Crossover Post-herpetic Neuralgia (PHN)

Phase 2

Completed

• Conditions: Post-Herpetic Neuralgia (PHN)
• Interventions: Drug: BMS-954561; Drug: Placebo

• Registration Number: NCT01305538
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with post-herpetic neuralgia (PHN).

Detailed Description

Allocation: Randomized Stratified

Interventional model: Cross-over Placebo Controlled

Study Timeline

• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-02-28
• Study Start: 2011-03
• Primary Completion: 2012-02
• Study Completion: 2012-06
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Disposition First Posted: 2015-10-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-06
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient with Post-Herpetic Neuralgia (PHN) as defined as pain present for more than 6 months after the onset of a herpes zoster skin rash affecting the trigeminal, cervical, thoracic, lumbar, or sacral regions.
• Based on patient diary information collected during the Baseline week (day -7 to randomization Day 1), patient has completed at least 5 diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale.
• The patient is able to satisfactorily complete, in the Investigator's judgment, the Cognitive Battery.
• Male or female, 18-85 years of age.

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Exclusion Criteria

• Other severe pain that may potentially confound pain assessment.
• History of complete lack of response to pregabalin (at least 300 mg qd for 4 weeks) or gabapentin (at least 1800 mg qd for 4 weeks).
• Hemoglobin A1c > 9%
• Hemoglobin ≤ 9 g/dL.
• Active herpes zoster or known viral infection.
• Previous neurolytic or neurosurgical therapy for PHN.
• Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 40ml/min/1.73m2.
• Patients who have been on a stable dose of anticonvulsant,anticholinergic, antiviral medications, nicotine replacements, or any other smoking cessation medications for <4 weeks prior to randomization. Patients who are on stable doses for => 4 weeks prior to randomization are allowed, however, there should be no adjustments to the dose of these medications during study.
• Patients currently on more than one drug for treatment of neuropathic pain (low dose opioids, antidepressants, or anticonvulsants). Patients are allowed to participate if on a stable dose for at least 4 weeks prior to randomization (Day1) and should remain stable during course of study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1 BMS-954561 40mg or 80mg	BMS-954561	Arm description: BMS-954561 40mg or 80mg three times daily (TID) to Placebo OR Placebo to 40mg or 80mg TID. Arm type: Active to Placebo or Placebo to Active (cross-over)
Arm 1 BMS-954561 40mg or 80mg	Placebo	Arm description: BMS-954561 40mg or 80mg three times daily (TID) to Placebo OR Placebo to 40mg or 80mg TID. Arm type: Active to Placebo or Placebo to Active (cross-over)
Arm 2 BMS-954561 150mg or 300mg	BMS-954561	Arm description: BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Arm type: Active to Placebo or Placebo to Active(cross-over)
Arm 2 BMS-954561 150mg or 300mg	Placebo	Arm description: BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Arm type: Active to Placebo or Placebo to Active(cross-over)

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.	up to 10 weeks

Secondary Outcome Measures

Name	Time	Method
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).	Open-Label Phase: Weeks 20
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.	Open-Label Phase: Weeks 20
Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.	Open-Label Phase: Weeks 20

Trial Locations

Locations (20)

Radiant Research, Inc.; 🇺🇸 Akron, Ohio, United States

Medex Healthcare Research, Inc; 🇺🇸 St. Louis, Missouri, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Brain Matters Research; 🇺🇸 Delray Beach, Florida, United States

Drug Studies America; 🇺🇸 Marietta, Georgia, United States

Commonwealth Biomedical Research, Llc; 🇺🇸 Madisonville, Kentucky, United States

Analgesic Solutions; 🇺🇸 Natick, Massachusetts, United States

Quest Research Institute; 🇺🇸 Farmington Hills, Michigan, United States

Comprehensive Clinical Development, Inc.; 🇺🇸 St Petersburg, Florida, United States

The Center For Pharmaceutical Research. Pc; 🇺🇸 Kansas City, Missouri, United States

Finger Lakes Clinical Research; 🇺🇸 Rochester, New York, United States

Cor Clinical Research; 🇺🇸 Oklahoma City, Oklahoma, United States

Local Institution; 🇫🇷 Saint Priest En Jarez, France

Compass Research, Llc; 🇺🇸 Orlando, Florida, United States

Alpine Clinical Research Center; 🇺🇸 Boulder, Colorado, United States

Torrance Clinical Research; 🇺🇸 Lomita, California, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

Pmg Research Of Winston-Salem; 🇺🇸 Winston-Salem, North Carolina, United States

Wake Research Associates, Llc; 🇺🇸 Raleigh, North Carolina, United States

Futuresearch Trials Of Neurology; 🇺🇸 Austin, Texas, United States