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Clinical Trials

Chronic Pain Studies in the Department of Pain Medicine and Palliative Care at Beth Israel
List of Open Trials
ClinicalTrials.gov
IFPMA Clinical Trials Portal
American Pain Foundation Clinical Trials Resource Center


Chronic Pain Studies in the Department of Pain Medicine and Palliative Care at Beth Israel

Pain is one of the most common reasons for visiting a physician. Although there are a wide range of treatments now available, new approaches are being investigated. At Beth Israel Medical Center's Department of Pain Medicine and Palliative Care, studies are currently recruiting patients with some types of neuropathic pain, pain due to cancer, low back pain, and pain associated with multiple sclerosis and osteoarthritis.

Neuropathic pain includes many conditions caused by injury to nerves. The discomfort experienced by patients with this type of pain can be severe, long-lasting, and not easily treated by current analgesics.

Clinical trials are also currently underway to study postherpetic neuralgia, fatigue in cancer and AIDS, the micronutrient L-carnitine, and treatments for breakthrough pain. New methods of structuring doctor-patient relationships are also being investigated, as well as the development of strategies to increase access to pain specialists in the United States.

For more information write or call

Jeanne A. Lapin, RN
Department of Pain Medicine and Palliative Care
Institute for Education and Research
Beth Israel Medical Center
16th Street and First Avenue
NY, NY 10003
Phone: (212) 844-1475
Email: stoppain@chpnet.org

List of Open Trials

Breakthrough Pain in Patients with Cancer

IRB #213-05 A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of EN3267 for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients Followed by an up to 12-Month Non-Randomized, Open-Label Extension to Assess Long-Term Safety - Protocol EN3267-005

Principal Investigator: Russell K. Portenoy, MD
Contact: Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment

Design: Endo Pharmaceuticals Inc. is conducting a research study of an experimental drug called EN3267 as a therapy in the management of breakthrough pain (intermittent or irregular flares of pain that can occur suddenly). The study drug, EN3267, is the drug fentanyl citrate. Subjects will be instructed to place the study medication under the tongue and allow it to dissolve. The medication should dissolve completely in approximately 1 minute. This dosing method of fentanyl is a new investigational preparation.

The purpose of this study is to compare the effectiveness (the power to produce an effect) of EN3267 with that of placebo (inactive substance or “sugar pill”) in treating breakthrough pain episodes in subjects with cancer.

The first part of the study begins with a titration of EN3267 (methods of increasing the study drug that a study participant will take until a dose is reached that best works for his/her breakthrough pain). Every participant will receive EN3267 during this study period. Once a dose has been identified as an adequate treatment for their breakthrough pain, subjects will enter the double-blind part of the study. In the double-blind part, they will be assigned by chance, to get either EN3267 or placebo (a look-alike with no active ingredients, sometimes called a sugar pill) during the treatment period of the study.

The second part of the study is an open-label, long-term extension period. Subjects who complete the double-blind period may continue to use EN3267 to treat breakthrough pain episodes over a 12-month period.

Participation will involve approximately 13 months with up to 18 separate visits at the site.




Breakthrough Pain in Patients with Cancer

IRB #214-05 A Multiple-Dose, Non-Randomized, Open-Label, Multicenter Study to Evaluate the Long-Term Safety and Effectiveness of EN3267 in the Treatment of Breakthrough Pain in Cancer Patients - Protocol EN3267-007

Principal Investigator: Russell K. Portenoy, MD
Contact: Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment

Design: EN3267, a rapidly dissolving tablet formulation of fentanyl citrate, is currently under development for the treatment of breakthrough cancer pain in patients already receiving an opioid (narcotic) medication for pain. This formulation of fentanyl is designed specifically to be placed under the tongue and allowed to dissolve. The medication should dissolve completely in approximately 1 minute. This dosing method of fentanyl is a new investigational preparation.

Eligible study participants will begin a titration of EN3267 (methods of increasing EN3267 that study participants will take until a dose is reached that best works for their breakthrough pain). Every participant will receive EN3267 during this study period.

Once a dose has been identified as an adequate treatment for their breakthrough pain, subjects will be able to receive EN3267 for up to 12 months to treat breakthrough pain episodes. Patients will return to the study site each month.

Safety and effectiveness of EN3267 will be assessed throughout the 12 months.




Breakthrough Pain in Patients with Cancer

IRB #237-05 A Double-Blind, Placebo Controlled, Evaluation of the Efficacy, Safety and Tolerability of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects - Protocol FEN-201

Principal Investigator: Russell K. Portenoy, MD
Contact: Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment

Design: Subjects with chronic cancer-related pain often experience episodes of pain, called “breakthrough” pain. Breakthrough pain occurs between doses of regularly scheduled (around-the-clock), long-acting pain medication.

BioDelivery Sciences International, Inc. has developed a small disc containing fentanyl which is placed on the inside of the cheek. The purpose of this study is to determine if BioErodible MucoAdhesive fentanyl (BEMA™ fentanyl) is safe and effective in the treatment of breakthrough pain in cancer subjects.

Subjects with chronic cancer-related pain, having frequent episodes of breakthrough pain, will enter the titration phase of the study. During this portion of the study, the best dose of BEMA™ fentanyl to control the breakthrough pain will be determined for each subject. Once a subject’s effective dose is determined, the subject will then enter the randomized portion of the study. All eligible subjects will then receive 9 doses of the study medication. The dose of BEMA™ fentanyl will be the same dose determined to be effective for each subject during the titration period. Three of the discs will be placebo (a dummy treatment that contains no active ingredients) and 6 will contain fentanyl. The order in which the study drug (BEMA™ fentanyl or placebo) is given will be randomized. In this study, randomized means the 9 discs will be administered in a mixed-up order so that neither the subject nor the doctor will know if the disc is fentanyl or placebo (this is referred to as ‘double-blind’).

Males and non-pregnant females over the age of 18 years, who are receiving the equivalent of 60 – 1000 mg oral morphine per day for chronic cancer-related pain and are experiencing at least one episode of breakthrough pain per day, will be eligible to participate.

The duration of the study is 29 days and consists of 4 clinic visits.




Breakthrough Pain in Patients with Cancer

IRB #238-05 An Open Label, Long-Term Treatment Evaluation of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy - Protocol FEN-202

Principal Investigator: Russell K. Portenoy, MD
Contact: Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment

Design: BioDelivery Sciences International, Inc. has developed a small disc containing fentanyl which is placed on the inside of the cheek. The purpose of this study is to determine if BioErodible MucoAdhesive fentanyl (BEMA™ fentanyl) is safe and effective in the treatment of breakthrough pain in cancer subjects.

The study will continue for an unlimited period of time and consists of monthly clinic visits. Open label means that all subjects will receive the active study drug BEMA™ fentanyl and that both the subject and the study physician will know the dose that is being prescribed.

Subjects are eligible to enter following successful completion of the previous study, FEN-201 (IRB #237-05), and will be able to continue on the effective dose used in that study with dose adjustments as needed.

In addition, other subjects with chronic cancer-related pain that experience frequent episodes of acute (breakthrough) pain can also be enrolled in this study.

The subject and the study doctor will identify, ahead of time, a specific type of breakthrough pain (“target episodes”) that will be treated with BEMA™ fentanyl. In the titration phase of the study, the best dose of BEMA™ fentanyl to control the breakthrough pain will be determined for each subject. Once the dose is determined, subjects will then enter the open-label phase of the study where they will take BEMA™ fentanyl for breakthrough pain.

Participating subjects will be asked to visit the study doctor up to 3 times during the first 2 weeks to establish their required dose of BEMA™ fentanyl. After that, they will be required to visit the study doctor every 4 weeks for as long as they continue in the study. The first visit will take approximately 1-2 hours.




Breakthrough Pain in Patients with Chronic Pain

IRB# 131-06 A 12-Week Open-Label Study with 3 Within-Patient Double-Blind Placebo-Controlled Periods to Evaluate the Efficacy and Safety of ORAVESCENT® Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients with Noncancer-Related Chronic Pain

Principal Investigator: Russell K. Portenoy, MD
Contact: Andrew Kobets 212-844-1491 or Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment

Design: The study drug, OraVescent® fentanyl citrate, is an investigational drug (a new compound), that has not yet been approved by the U.S. Food and Drug Administration (FDA). It is being studied as a therapy in the management of breakthrough pain (intermittent or irregular flares of pain) in patients with chronic (long-term) pain.

Included in the study will be adult subjects 18 through 80 years of age who have chronic pain (i.e., pain is of at least 3 months duration) that is associated with any of the following conditions: back pain, neck pain, diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, fibromyalgia, osteoarthritis, and chronic pancreatitis. Patients with other chronic painful conditions may qualify for the study with permission from the Sponsor, Cephalon, Inc.

OraVescent® fentanyl citrate is a newly designed tablet that releases a drug called fentanyl citrate into the body. To administer the medication, the tablet is placed in the mouth between the cheek and gum, and allowed to dissolve (about 10 minutes).

The study begins with all subjects receiving ORAVESCENT® fentanyl to be used to determine, through titration, each person’s successful dose. The dose of ORAVESCENT® fentanyl identified to be successful is defined as a single dose that provides adequate analgesia for that person without unacceptable adverse events. Subjects will then be treated with open-label ORAVESCENT® fentanyl for 4 weeks, followed by a double-blind treatment period (treating 9 breakthrough pain episodes) to assess the effectiveness of ORAVESCENT® fentanyl compared to placebo (tablets that look like ORAVESCENT® fentanyl but have no active ingredient). This cycle will be repeated twice.

All subjects will return for 9 clinic visits to assess safety and tolerability. The need to adjust the dose of the study medication during the study will be taken into account.

Eligible subjects will be compensated for their time and travel expense required to participate in the study.




Daytime Sleepiness Due to Opioid Therapy

IRB #060-06 A Double-Blind, Randomized, Placebo-Controlled Study of Modafinil and Morphine in Patients with Excessive Daytime Sleepiness Due to Opioid Therapy

Principal Investigator: Russell K. Portenoy, MD
Contact: Andrew Kobets 212-844-1491 or Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment

Design: Medgenex, Inc. is conducting a research study with a drug called modafinil as a therapy in the management of daytime sleepiness. The purpose of this research study is to evaluate how well modafinil will decrease the sleepiness that may occur throughout the day when persons are taking opioid (narcotic) pain medications such as morphine. The Food and Drug Administration (FDA) has not approved this drug for treating daytime sleepiness caused by opioid (narcotic) pain medications, and so for that reason, it is considered to be investigational.

Modafinil is currently approved by the FDA for other disorders that affect sleeping habits.

The study will enroll subjects ages 18 and older with moderate to severe chronic pain who are receiving a stable, oral opioid regimen equivalent to 30 to 800 mg of oral morphine per day and who have been on opioid therapy for at least 3 months. Eligibility criteria include only those patients who have been identified as having excessive daytime sleepiness.

Eligible subjects will be “randomized” into one of three groups. Randomized means that a subject is put into a group by chance, much like flipping a coin. Subjects will receive either the study drug (modafinil 200 mg or modafinil 400 mg) or placebo (like a sugar pill without active drug) once a day at approximately 8:00 AM in the morning.

This is a double-blind study. That means that neither the subject nor the study investigator will know which study drug the subject will receive. The reason for not knowing if the subject is taking the study drug or the placebo is to test the effects of the drug in a way that will not be influenced by anyone’s opinions or expectations.

The study will last for no longer than 8 weeks. Once the subject begins to take the study drug, treatment will continue for 4 weeks. Subjects will be asked to return to the study clinic several times during the study. These clinic visits will last about one hour.

Eligible subjects will be compensated for their time and travel expense required to participate in the study.




Fatigue in Patients with Cancer

IRB #175-04 Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients with Cancer - Protocol E4Z02

Principal Investigator: Ricardo Cruciani, MD, PhD
Contact: Ella Dvorkin, MSW, CSW, (212) 844-1483
Status: Open for Enrollment

Design: This study is being funded by a grant from the Eastern Cooperative Oncology Group (ECOG). ECOG is a cancer group that conducts studies for the National Cancer Institute. The study doctor is a member of ECOG.

The purpose of this study is to determine whether L-carnitine supplementation will improve fatigue and related phenomena in subjects with cancer. Adult subjects with a diagnosis of cancer and significant persistent fatigue at the time of the screening interview will be evaluated for eligibility.

In the study phase, patients will receive either the study drug (L-carnitine) or a placebo. The doses of study drug and placebo will be titrated over 2 days to the desired study dose. This phase will last for 4 weeks. In the following extension phase, which will continue for an additional 4 weeks, all the patients enrolled in the study will receive L-carnitine. The extension phase will ensure that patients who originally received placebo have the opportunity to receive a potentially beneficial drug.

Subjects may consent to have an additional tube of blood collected before they start treatment and during their Week 4 evaluation. Researchers hope these blood tests will help them learn more about cancer and other diseases.




Headache

IRB #036-06 Evaluation of Response to Treatment, Quality of Life, and Aberrant Behavior in Patients Receiving Opioids for Headaches. A Case Series

Principal Investigator: Ricardo Cruciani, MD, PhD
Contact: Jeanne Lapin, RN, 212-844-1475
Status: Open for Enrollment

Design: This is a case series to determine the response to opioid treatment, aberrant behavior, and quality of life of patients with headaches currently under the care of a physician in the Department of Pain Medicine and Palliative Care.

Active patients will be grouped by different types of headache following the guidelines of the International Association for Headaches, obtaining the information from patient interview and medical records. Questionnaires will help to confirm the type of headache, determine the types of medications that patients are taking, assess quality of life, frequency and severity of headaches, visits to the emergency room, and the presence or absence of aberrant behavior.




Improving Quality of Care

IRB #130-03 Rethinking Doctor-Patient Relationships

Principal Investigator: Russell K. Portenoy, MD
Contact: Michael Yedidia, PhD, 212-998-7447
Status: Open for Enrollment

Design: New methods of structuring doctor-patient relationships will be investigated in this research project with the intent to promote patient-centered care. The study will consist of a structured interview. The responses from participants will contribute to recommendations for a new training process for physicians, preparing them to assume new roles in relationships with patients so as to improve the quality of care.

Subjects will be systematically selected to include individuals from a variety of settings and socio-demographic groups in order to capture diverse views; women and minority patients and providers will be over-sampled whenever possible. All respondents will be over the age of 21. Other criteria for inclusion are that subjects converse easily in English and that they are sufficiently alert to discuss the topics addressed in the study.

The study is being conducted by Dr. Michael Yedidia, a faculty member at the Wagner Graduate School of Public Service at New York University in collaboration with Department of Pain Medicine and Palliative Care at Beth Israel Medical Center.




L-Carnitine in Patients with AIDS

IRB #098-02 Phase II Developmental Study on Fatigue in AIDS Patients

Principal Investigator: Ricardo Cruciani, MD, PhD
Contact: Ella Dvorkin, MSW, CSW, (212)-844-1483
Status: Open for Enrollment

Design: Fatigue is a commonly reported symptom in patients with AIDS placing them at risk for micronutrient deficiencies because of decreased caloric intake, increased metabolic requirements, and treatment with medications that can interfere with its absorption, synthesis, and excretion.

In the present study, L-carnitine is used to treat patients with carnitine deficiency, fatigue, and Stage IV-C AIDS. This study is being funded by a grant from the Nation Institutes of Health (NIH).

Patients are randomized to receive oral L-carnitine or a suitable placebo, 2 times/day, over a 2-week period in double-blind fashion. A dose titration will be used to decrease the possibility of adverse effects. Questionnaires to assess fatigue, performance status, cognitive function, mood, and quality of life are completed at baseline and at specific intervals. At Week 3, all patients will be supplemented with a standard dose of L-carnitine.

No major risks are anticipated from the administration of this dietary supplement. Long term oral administration of L-carnitine may cause mild gastrointestinal symptoms that include nausea and vomiting, abdominal cramps and diarrhea.

The total duration of the study will be 5 weeks and will include a total of four study visits.




Low Back Pain Study

IRB #106-03 A Pilot Trial of IV Pamidronate for Low Back Pain

Principal Investigator: Marco Pappagallo, MD
Contact: Brenda Breuer, PhD, (212) 844-1290
Status: Open for Enrollment

Design: This is a single center, randomized, double-blind, placebo-controlled dose escalation pilot study. The primary objective is to determine which pamidronate treatment protocol is optimal for the Phase III trial.

Pamidronate belongs to a class of drugs used to treat weak or brittle bones. The purpose of this research study is to evaluate the effect of pamidronate on chronic low back pain. While preliminary results with pamidronate for low back pain are promising, well-designed trials are needed to determine the true effectiveness of this drug for low back pain.

Study subjects will receive intravenously (injection into a vein) administered placebo or pamidronate. There will be very close monitoring via blood tests, physical examinations, and telephone contact with subjects.

Eligible participants include males and females over age 21, with non-cancer-related low back pain that has been present for at least 3 months.

Risks associated with pamidronate include flu-like symptoms within 3 days of the treatment. The development of local inflammation of a vein, increased bleeding from low platelets, and low blood calcium or magnesium levels is rare.




Neuropathic Pain

IRB #104-03 Pharmacokinetics-Pharmacodynamics Study of Levetiracetam in Patients with Neuropathic Pain: A Two-Phase 'Enriched Enrollment' Design Including A Randomized Crossover Study

Principal Investigator: Ricardo Cruciani, MD, Ph.D.
New Contact: Helena Knotkova, PhD, (212) 420-3823
Status: Open for Enrollment.

Design: Levetiracetam is a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of epilepsy. Research data suggest that it may be useful in the treatment of neuropathic pain (pain caused by nerve damage). The purpose of this research study is to evaluate the safety and efficacy (ability to decrease pain) of levetiracetam for the treatment of neuropathic pain. Levetiracetam is not currently approved by the FDA for the treatment of pain and is, therefore, considered experimental.

Patients with a diagnosis of neuropathic pain will be considered for study. Examples of neuropathic pain include diabetic neuropathy (DN), toxic neuropathy, HIV neuropathy, post-herpetic neuralgia (PHN), post-stroke pain, and complex regional pain syndrome (CRPS).

This is a two-phase study designed to assess the efficacy and safety of levetiracetam to treat neuropathic pain. The first phase is an open-label trial of levetiracetam at escalating doses, for a maximum duration of 12 days. Subjects who respond to levetiracetam (decreased daily 'pain on average') will be enrolled in the second phase. In this second phase, subjects will receive either the study drug (levetiracetam) or a placebo tablet (a tablet that does not contain any active drug). Each period includes a there-day baseline period, maximum 12 days of drug titration and one maintenance week. One week of medication tapering and one week off study medication will separate the two periods.

The maximum duration of the study is 66 days.




Painful Conditions of the Wrist

IRB #092-05 A Study of the Effectiveness and Safety of the Carpal-Ease Unit for the Treatment of Wrist Pain

Principal Investigator: Peter Homel, PhD
Contact: Peter Homel, PhD, (212) 844-1490
Status: Open for Enrollment

Design: This is a research study of an experimental device called Carpal-Ease as a therapy in the management of painful conditions of the wrist. The Carpal-Ease unit is investigational, which means that it has not received marketing approval from the U.S. Food and Drug Administration (FDA).

This research study is being done to see if the Carpal-Ease unit is an effective treatment for wrist pain due to carpal tunnel syndrome, wrist arthritis or wrist repetitive stress syndrome. The study will compare the active treatment, when the Carpal-Ease unit is turned on, to a placebo (when the unit is turned off).

The Carpal-Ease unit is a newly designed system that uses a low voltage electrical energy to encourage the flow of excess fluid (swelling) inside the carpal tunnel to flow outward. The result relieves pressure on the median nerve, which in turn leads to reduction in pain and greater ease of movement.

The study will take place over four weeks.




Painful Oral Mucositis

IRB #261-04 A Study of the Feasibility of Avinza Administered via Gastric Tube for Treatment of Pain in Head and Neck Cancer Patients Undergoing Radiation Therapy

Principal Investigator: Russell K. Portenoy, MD
Contact: Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment

Design: Avinza is a 24-hour formulation of morphine sulfate and has been approved by the U.S. Food and Drug Administration (FDA) to treat chronic pain in patients who need around the clock therapy for an extended period of time. In this study, the Avinza capsule will be opened and the contents given through a gastric (stomach) tube. The way that Avinza will be given in this study is experimental.

Avinza is a long acting morphine formulation that is intended for ‘once a day’ dosing. It comes in a capsule containing two forms of morphine. One is for immediate release in order to provide immediate relief of pain. The other is for extended release over the course of 24 hours to maintain steady pain relief over time. The purpose of this research study is to evaluate the safety and effectiveness of Avinza when given once a day by way of a gastric tube in patients receiving radiation therapy as treatment for head and neck cancer. In this study, all patients will receive the active study medication, Avinza.

Adult patients between 18 and 65 years of age and currently receiving radiation therapy for the treatment of head and neck cancer will be considered for study. Eligible patients will qualify for the study if they have pain as a result of oral mucositis and their treating physician has discussed the need for a gastric tube placement because of their oral mucositis. Oral mucositis is the medical term used to describe the inflammation and painful sores that develop in the mouth.

The study will last for 12 weeks with 9 clinic visits required.




Postherpetic Neuralgia (pain after shingles)

IRB #019-06 [S,S]-Reboxetine Dose-range Finding Trial: A 16-week, Randomized, Double-blind, Placebo and Pregabalin Controlled, Multi-center Trial of [S,S]-Reboxetine in Patients with Postherpetic Neuralgia (PHN) - Protocol A6061026

Principal Investigator: Russell K. Portenoy, MD
Contact: Andrew Kobets 212-844-1491
Status: Open for Enrollment

Design: Pfizer, Inc. is conducting a research study with a drug called [S,S]-Reboxetine ([S,S]-RBX) as a therapy in the management of chronic pain following a shingles infection, called postherpetic neuralgia (PHN). The study drug is a new investigational preparation. An investigational product is one that has not yet been approved by the U.S. Food and Drug Administration (FDA).

The purpose of this research study is to evaluate the effectiveness, safety, and tolerability of [S,S]-RBX in subjects with postherpetic neuralgia (PHN).

Because this is a research study, [S,S]-RBX will only be given during study participation, and if the subject continues in the open label extension study (Protocol Number: A6061029) that follows this study. The open-label study allows participants to continue to use [S,S]-RBX for an extended period of time. To enter the open label extension study certain conditions must be met including the completion of this current study.

In this study, participants will either get [S,S]-RBX, or Pregabalin, or placebo. Placebo is a pill that does not contain any drug. Pregabalin (marketed as Lyrica®) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of PHN. The order in which the study drug ([S,S]-RBX, or Pregabalin, or placebo) is given will be randomized. In this study, randomization means that you have a 75% chance of getting [S,S] RBX, and a 12.5% chance of getting either Pregabalin or placebo. This means 2 out of 8 people will get placebo or pregabalin. The study medication will be assigned in a mixed-up order so that neither you nor the study doctor will know if you get placebo or Pregabalin or [S,S]-RBX (this is referred to as ‘double-blind’).

During the course of the study subjects will be required to come to the clinic 9 times. Some study visits may be very short (for example, half an hour) whereas others may be longer (for example, 2 hours). The study should last about 16 weeks in total.

Eligible subjects will be compensated for their time and travel expense required to participate in the study.




Postherpetic Neuralgia (pain after shingles)

IRB #130-06 An Open-Label Extension Trial Assessing the Safety and Tolerability of [S,S]-Reboxetine in Patients with Postherpetic Neuralgia (PHN) - Protocol A6061029

Principal Investigator: Russell K. Portenoy, MD
Contact: Andrew Kobets 212-844-1491
Status: Open for Enrollment

Design: This is an open-label extension study of [S,S]-RBX for subjects with chronic pain following a shingles infection, called postherpetic neuralgia (PHN). Eligibility includes only those participants who have completed the preceding 16 week double-blind protocol A6061026 (IRB #019-06).

Open label means that all subjects will receive the active study drug [S,S]-RBX and that both the subject and the study physician will know the dose that is being prescribed. The aims of this study are to assess the long-term safety, efficacy, and tolerability of [S,S]-RBX.

There are different doses of [S,S]-RBX included in this study as the dose is adjusted (titrated) based on the subject’s response to the study medication. During the first week, subjects will start with a total daily dose of 1 mg [S,S]-RBX. Dose increases may occur at any time after Day 7 (Visit 2) and will be conducted in 1 mg increments up to a maximum total daily dose of 8 mg of [S,S]-RBX. Stepwise dose reduction is also conducted in 1 mg decrements.

The study investigators will be attempting to adjust the dose until favorable clinical effects develop. The purpose of increasing or decreasing the dose is to find out what the best dose for each participant might be. Dose adjustment may occur either at scheduled clinic visits, or at an unscheduled visit.

If subjects are eligible and agree to participate, their participation in this study may last up to 2 years. Subjects will be asked to return to the study clinic on 14 occasions during the course of the study.

Eligible subjects will be compensated for their time and travel expense required to participate in the study.




Postherpetic Neuralgia (pain after shingles)

IRB #186-05 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study Conducted Under In-House Blinding Conditions to Evaluate the Safety and Efficacy of Oral MK-0686 in the Treatment of Postherpetic Neuralgia

Principal Investigator: Russell K. Portenoy, MD
Contact: Andrew Kobets 212-844-1491
Status: Open for Enrollment

Design: If the pain from shingles does not go away, it is called postherpetic neuralgia (PHN). Only a small number of people with shingles develop PHN.

Merck & Co., Inc. is conducting a research study of an experimental drug called MK-0686 as a therapy in the management of PHN. The study drug, MK-0686, is a new investigational preparation. An investigational product is one that has not yet been approved by the U.S. Food and Drug Administration (FDA).

Participants must be between the ages of 18 and 80 to participate in this study and have a diagnosis of PHN with pain persisting for at least 6 months.

Subjects will be assigned by chance to get either MK-0686 or placebo (a look-alike with no active ingredients, sometimes called a sugar pill) during each treatment period of the study. Neither the subjects nor the study doctor will know which of these they are receiving. Every participant will receive MK-0686 for a period of time during the study. There will also be a period of time when all participants will receive placebo and not active treatment.

The study is expected to last for 7 weeks with up to 8 clinic visits expected.

Eligible subjects will be compensated for their time and travel expense required to participate in the study.




Spinal Cord Injury

IRB #197-04 Study of Levetiracetam in Patients with Central Pain Following Spinal Cord Injury: A Randomized Crossover Study

Principal Investigator: Ricardo Cruciani, MD, PhD
Contact: Jeanne Lapin, RN, 212-844-1475
Status: Open for Enrollment

Design: Levetiracetam (Keppra®) is a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of epilepsy. Research data suggest that it may be useful in the treatment of neuropathic pain (pain caused by nerve damage). The purpose of this research study is to evaluate the safety and efficacy (ability to decrease pain) of levetiracetam for the treatment of central neuropathic pain following complete spinal cord injury. Levetiracetam is not currently approved by the FDA for the treatment of pain and is, therefore, considered experimental.

This study will be conducted at the Bronx Veterans Administration Medical Center with oversight from Beth Israel Medical Center. The study is expected to last up to 16 weeks with all of the study visits taking place at the Bronx Veterans Administration Medical Center.

This is a two-phase study designed to assess the efficacy and safety of levetiracetam to treat neuropathic pain. The first phase is an open-label trial of levetiracetam with escalating doses. Subjects who respond to levetiracetam (decreased daily 'pain on average') will be enrolled in the second phase. In this second phase, subjects will receive either the study drug (levetiracetam) or a placebo tablet (a tablet that does not contain any active drug). Each period includes a baseline period, a period of drug titration and a maintenance period.




Testosterone Replacement in Opioid-Treated Hypogonadal Men with Persistent Pain

IRB #229-04 Safety and Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-Treated Chronic Pain Patients: A Controlled Trial

Principal Investigator: Ricardo Cruciani, MD, PhD
Contact: Helena Knotkova, PhD, 212-420-3823
Status: Open for Enrollment

Design: The study drug, AndroGel® is a clear colorless gel containing 1% testosterone. AndroGel® has been approved by the Food and Drug Administration (FDA) and is currently available in the United States. It is being studied to determine if testosterone replacement can improve pain control in male subjects on an opioid (narcotic) analgesic and who have been found to have hypogonadism (a low level of testosterone in the body).

AndroGel® provides continuous transdermal (through the skin) delivery of testosterone for 24 hours following a single application to skin’s surface of the shoulders, upper arms and/or abdomen. In this study, patients will receive either the study drug (AndroGel®) or a placebo gel. The placebo gel will contain an inactive substance (no active drug).

Adult male patients between the ages of 18 and 50 who are receiving an opioid for the treatment of chronic pain will be considered for this 6-week study. Eligibility includes a total testosterone level below 300 ng/dl and a free testosterone of below 50 pg/ml.

The study requires 4 visits to assess safety, effectiveness and tolerability.




For more information on these studies, or to see if your patients qualify for participation, please write or call:

Jeanne A. Lapin, RN
Department of Pain Medicine and Palliative Care
Institute for Education and Research
Beth Israel Medical Center
16th Street and First Avenue
NY, NY 10003
Telephone: (212) 844-1475
Email: stoppain@chpnet.org

   
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