Crossover Post-herpetic Neuralgia (PHN)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01305538
First received: February 14, 2011
Last updated: November 28, 2012
Last verified: November 2012
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| 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
Capsule, Oral, 40mg or 80mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)
Other Name: BMS-954561
Drug: Placebo
Capsule, Oral, 0.0 mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label)
|
|
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
Capsule, Oral, 150mg or 300 mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)
Other Name: BMS-954561
Drug: Placebo
Capsule, Oral, 0.0 mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label)
|
Detailed Description:
Allocation: Randomized Stratified
Interventional model: Cross-over Placebo Controlled
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305538
Hide Study Locations
Hide Study LocationsLocations
| 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:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01305538 History of Changes |
| Other Study ID Numbers: | CN169-002, 2010-023041-30 |
| Study First Received: | February 14, 2011 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices |
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 May 16, 2013