Crossover Post-herpetic Neuralgia (PHN)

Post-Herpetic Neuralgia (PHN) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305538
• Other study ID #: CN169-002
• Secondary ID: 2010-023041-30
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2011
• Last updated: November 6, 2015
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: November 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Description:

Allocation: Randomized Stratified

Interventional model: Cross-over Placebo Controlled

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Post-Herpetic Neuralgia (PHN)

Intervention

Drug:
• BMS-954561

• BMS-954561

• Placebo

Locations

Country	Name	City	State
France	Local Institution	Bordeaux Cedex
France	Local Institution	Boulogne-Billancourt
France	Local Institution	Nice Cedex 1
France	Local Institution	Saint Priest En Jarez
United States	Radiant Research, Inc.	Akron	Ohio
United States	Futuresearch Trials Of Neurology	Austin	Texas
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Brain Matters Research	Delray Beach	Florida
United States	Quest Research Institute	Farmington Hills	Michigan
United States	The Center For Pharmaceutical Research. Pc	Kansas City	Missouri
United States	Torrance Clinical Research	Lomita	California
United States	Commonwealth Biomedical Research, Llc	Madisonville	Kentucky
United States	Drug Studies America	Marietta	Georgia
United States	Analgesic Solutions	Natick	Massachusetts
United States	Renstar Medical Research	Ocala	Florida
United States	Cor Clinical Research	Oklahoma City	Oklahoma
United States	Compass Research, Llc	Orlando	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	Wake Research Associates, Llc	Raleigh	North Carolina
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Comprehensive Clinical Development, Inc.	St Petersburg	Florida
United States	Medex Healthcare Research, Inc	St. Louis	Missouri
United States	Pmg Research Of Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.		up to 10 weeks	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Screening/Baseline Phase: Baseline	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Weeks 1	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Weeks 2	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Weeks 3	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Weeks 4	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Weeks 5	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Weeks 6	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Weeks 7	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Weeks 8	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Weeks 9	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Weeks 10	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Open-Label Phase: Weeks 2	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Open-Label Phase: Weeks 4	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Open-Label Phase: Weeks 8	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Open-Label Phase: Weeks 12	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Open-Label Phase: Weeks 16	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Open-Label Phase: Weeks 20	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Weeks 1	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Weeks 2	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Weeks 3	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Weeks 4	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Weeks 5	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Weeks 6	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Weeks 7	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Weeks 8	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Weeks 9	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Weeks 10	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Open-Label Phase: Weeks 2	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Open-Label Phase: Weeks 4	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Open-Label Phase: Weeks 8	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Open-Label Phase: Weeks 12	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Open-Label Phase: Weeks 16	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Open-Label Phase: Weeks 20	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form