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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023041-30 | EudraCT Number |
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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).
Allocation: Randomized Stratified
Interventional model: Cross-over Placebo Controlled
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 BMS-954561 40mg or 80mg | Other | 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 | Other | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-954561 | Drug |
| ||
| BMS-954561 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo. | up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Screening/Baseline Phase: Baseline | |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Double-blind Treatment Phase: Weeks 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85023 | United States | ||
| Torrance Clinical Research |
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|
| Placebo | Drug |
|
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Double-blind Treatment Phase: Weeks 2 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Double-blind Treatment Phase: Weeks 3 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Double-blind Treatment Phase: Weeks 4 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Double-blind Treatment Phase: Weeks 5 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Double-blind Treatment Phase: Weeks 6 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Double-blind Treatment Phase: Weeks 7 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Double-blind Treatment Phase: Weeks 8 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Double-blind Treatment Phase: Weeks 9 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Double-blind Treatment Phase: Weeks 10 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Open-Label Phase: Weeks 2 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Open-Label Phase: Weeks 4 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Open-Label Phase: Weeks 8 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Open-Label Phase: Weeks 12 |
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Open-Label Phase: Weeks 16 |
| 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. | Double-blind Treatment Phase: Weeks 1 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Double-blind Treatment Phase: Weeks 2 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Double-blind Treatment Phase: Weeks 3 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Double-blind Treatment Phase: Weeks 4 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Double-blind Treatment Phase: Weeks 5 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Double-blind Treatment Phase: Weeks 6 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Double-blind Treatment Phase: Weeks 7 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Double-blind Treatment Phase: Weeks 8 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Double-blind Treatment Phase: Weeks 9 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Double-blind Treatment Phase: Weeks 10 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Open-Label Phase: Weeks 2 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Open-Label Phase: Weeks 4 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Open-Label Phase: Weeks 8 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Open-Label Phase: Weeks 12 |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Open-Label Phase: Weeks 16 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Open-Label Phase: Weeks 20 |
| Lomita |
| California |
| 90717 |
| United States |
| Alpine Clinical Research Center | Boulder | Colorado | 80304 | United States |
| Brain Matters Research | Delray Beach | Florida | 33445 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Compass Research, Llc | Orlando | Florida | 32806 | United States |
| Comprehensive Clinical Development, Inc. | St. Petersburg | Florida | 33716 | United States |
| Drug Studies America | Marietta | Georgia | 30060 | United States |
| Commonwealth Biomedical Research, Llc | Madisonville | Kentucky | 42431 | United States |
| Analgesic Solutions | Natick | Massachusetts | 01760 | United States |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | United States |
| The Center For Pharmaceutical Research. Pc | Kansas City | Missouri | 64114 | United States |
| Medex Healthcare Research, Inc | St Louis | Missouri | 63117 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Wake Research Associates, Llc | Raleigh | North Carolina | 27612 | United States |
| Pmg Research Of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Radiant Research, Inc. | Akron | Ohio | 44311 | United States |
| Cor Clinical Research | Oklahoma City | Oklahoma | 73103 | United States |
| Futuresearch Trials Of Neurology | Austin | Texas | 78731 | United States |
| Local Institution | Bordeaux | 33076 | France |
| Local Institution | Boulogne-Billancourt | 92100 | France |
| Local Institution | Nice | 06003 | France |
| Local Institution | Saint-Priest-en-Jarez | 42277 | France |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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