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Crossover Post-herpetic Neuralgia (PHN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01305538
First received: February 14, 2011
Last updated: November 6, 2015
Last verified: November 2015
  Purpose
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).

Condition Intervention Phase
Post-Herpetic Neuralgia (PHN)
Drug: BMS-954561
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Post-herpetic Neuralgia (PHN)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo. [ Time Frame: up to 10 weeks ]

Secondary Outcome Measures:
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Screening/Baseline Phase: Baseline ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 1 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 2 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 3 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 4 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 5 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 6 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 7 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 8 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 9 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 10 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Weeks 2 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Weeks 4 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Weeks 8 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Weeks 12 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Weeks 16 ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Weeks 20 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 1 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 2 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 3 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 4 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 5 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 6 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 7 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 8 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 9 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 10 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Weeks 2 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Weeks 4 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Weeks 8 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Weeks 12 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Weeks 16 ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: 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. [ Time Frame: Screening/Baseline Phase: Baseline ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Weeks 1 ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Weeks 2 ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Weeks 3 ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Weeks 4 ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Weeks 5 ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Weeks 6 ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Weeks 7 ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Weeks 8 ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Weeks 9 ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Weeks 10 ]
  • 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. [ Time Frame: Open-Label Phase: Weeks 2 ]
  • 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. [ Time Frame: Open-Label Phase: Weeks 4 ]
  • 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. [ Time Frame: Open-Label Phase: Weeks 8 ]
  • 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. [ Time Frame: Open-Label Phase: Weeks 12 ]
  • 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. [ Time Frame: Open-Label Phase: Weeks 16 ]
  • 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. [ Time Frame: Open-Label Phase: Weeks 20 ]

Enrollment: 100
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 BMS-954561 40mg or 80mg

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)

Drug: BMS-954561 Drug: Placebo
Arm 2 BMS-954561 150mg or 300mg

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)

Drug: BMS-954561 Drug: Placebo

Detailed Description:

Allocation: Randomized Stratified

Interventional model: Cross-over Placebo Controlled

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305538

  Hide Study Locations
Locations
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Torrance Clinical Research
Lomita, California, United States, 90717
United States, Colorado
Alpine Clinical Research Center
Boulder, Colorado, United States, 80304
United States, Florida
Brain Matters Research
Delray Beach, Florida, United States, 33445
Renstar Medical Research
Ocala, Florida, United States, 34471
Compass Research, Llc
Orlando, Florida, United States, 32806
Comprehensive Clinical Development, Inc.
St Petersburg, Florida, United States, 33716
United States, Georgia
Drug Studies America
Marietta, Georgia, United States, 30060
United States, Kentucky
Commonwealth Biomedical Research, Llc
Madisonville, Kentucky, United States, 42431
United States, Massachusetts
Analgesic Solutions
Natick, Massachusetts, United States, 01760
United States, Michigan
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
United States, Missouri
The Center For Pharmaceutical Research. Pc
Kansas City, Missouri, United States, 64114
Medex Healthcare Research, Inc
St. Louis, Missouri, United States, 63117
United States, New York
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
United States, North Carolina
Wake Research Associates, Llc
Raleigh, North Carolina, United States, 27612
Pmg Research Of Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Radiant Research, Inc.
Akron, Ohio, United States, 44311
United States, Oklahoma
Cor Clinical Research
Oklahoma City, Oklahoma, United States, 73103
United States, Texas
Futuresearch Trials Of Neurology
Austin, Texas, United States, 78731
France
Local Institution
Bordeaux Cedex, France, 33076
Local Institution
Boulogne-Billancourt, France, 92100
Local Institution
Nice Cedex 1, France, 06003
Local Institution
Saint Priest En Jarez, France, 42277
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01305538     History of Changes
Other Study ID Numbers: CN169-002
2010-023041-30 ( EudraCT Number )
Study First Received: February 14, 2011
Last Updated: November 6, 2015

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 28, 2017