Clinical trial NCT01305538: Crossover Post-herpetic Neuralgia (PHN)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Herpetic Neuralgia (PHN)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).

Detailed description: Allocation: Randomized Stratified

Interventional model: Cross-over Placebo Controlled

Eligibility 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.

Primary outcomes:
measure: The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.
timeFrame: up to 10 weeks
Secondary outcomes:
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Screening/Baseline Phase: Baseline
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Weeks 1
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Weeks 2
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Weeks 3
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Weeks 4
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Weeks 5
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Weeks 6
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Weeks 7
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Weeks 8
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Weeks 9
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Weeks 10
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Open-Label Phase: Weeks 2
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Open-Label Phase: Weeks 4
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Open-Label Phase: Weeks 8
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Open-Label Phase: Weeks 12
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Open-Label Phase: Weeks 16
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Open-Label Phase: Weeks 20
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Weeks 1
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Weeks 2
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Weeks 3
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Weeks 4
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Weeks 5
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Weeks 6
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Weeks 7
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Weeks 8
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Weeks 9
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Weeks 10
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Open-Label Phase: Weeks 2
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Open-Label Phase: Weeks 4
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Open-Label Phase: Weeks 8
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Open-Label Phase: Weeks 12
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Open-Label Phase: Weeks 16
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Open-Label Phase: Weeks 20
measure: 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.
timeFrame: Screening/Baseline Phase: Baseline
measure: 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.
timeFrame: Double-blind Treatment Phase: Weeks 1
measure: 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.
timeFrame: Double-blind Treatment Phase: Weeks 2
measure: 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.
timeFrame: Double-blind Treatment Phase: Weeks 3
measure: 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.
timeFrame: Double-blind Treatment Phase: Weeks 4
measure: 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.
timeFrame: Double-blind Treatment Phase: Weeks 5
measure: 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.
timeFrame: Double-blind Treatment Phase: Weeks 6
measure: 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.
timeFrame: Double-blind Treatment Phase: Weeks 7
measure: 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.
timeFrame: Double-blind Treatment Phase: Weeks 8
measure: 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.
timeFrame: Double-blind Treatment Phase: Weeks 9
measure: 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.
timeFrame: Double-blind Treatment Phase: Weeks 10
measure: 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.
timeFrame: Open-Label Phase: Weeks 2
measure: 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.
timeFrame: Open-Label Phase: Weeks 4
measure: 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.
timeFrame: Open-Label Phase: Weeks 8
measure: 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.
timeFrame: Open-Label Phase: Weeks 12
measure: 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.
timeFrame: Open-Label Phase: Weeks 16
measure: 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.
timeFrame: Open-Label Phase: Weeks 20
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Lomita
country: United States
facility: Torrance Clinical Research
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, Llc
state: Florida
city: St Petersburg
country: United States
facility: Comprehensive Clinical Development, Inc.
state: Florida
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, Llc
state: Kentucky
city: Natick
country: United States
facility: Analgesic Solutions
state: Massachusetts
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Kansas City
country: United States
facility: The Center For Pharmaceutical Research. Pc
state: Missouri
city: St. Louis
country: United States
facility: Medex Healthcare Research, Inc
state: Missouri
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates, Llc
state: North Carolina
city: Winston-Salem
country: United States
facility: Pmg Research Of Winston-Salem
state: North Carolina
city: Akron
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Cor Clinical Research
state: Oklahoma
city: Austin
country: United States
facility: Futuresearch Trials Of Neurology
state: Texas
city: Bordeaux Cedex
country: France
facility: Local Institution
city: Boulogne-Billancourt
country: France
facility: Local Institution
city: Nice Cedex 1
country: France
facility: Local Institution
city: Saint Priest En Jarez
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: