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 28, 2012
Last verified: November 2012
  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
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

  Show 23 Study Locations
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
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014