NCT01305538

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2

Geographic Reach
2 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 7, 2015

Status Verified

November 1, 2015

Enrollment Period

11 months

First QC Date

February 14, 2011

Last Update Submit

November 6, 2015

Conditions

Post-Herpetic Neuralgia (PHN)

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.

    up to 10 weeks

Secondary Outcomes (50)

  • 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

  • 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

  • +45 more secondary outcomes

Study Arms (2)

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)

Drug: BMS-954561Drug: Placebo

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)

Drug: BMS-954561Drug: Placebo

Interventions

BMS-954561DRUG
Arm 1 BMS-954561 40mg or 80mg
PlaceboDRUG
Arm 1 BMS-954561 40mg or 80mgArm 2 BMS-954561 150mg or 300mg

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Torrance Clinical Research

Lomita, California, 90717, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80304, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Compass Research, Llc

Orlando, Florida, 32806, United States

Location

Comprehensive Clinical Development, Inc.

St. Petersburg, Florida, 33716, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Commonwealth Biomedical Research, Llc

Madisonville, Kentucky, 42431, United States

Location

Analgesic Solutions

Natick, Massachusetts, 01760, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

The Center For Pharmaceutical Research. Pc

Kansas City, Missouri, 64114, United States

Location

Medex Healthcare Research, Inc

St Louis, Missouri, 63117, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Wake Research Associates, Llc

Raleigh, North Carolina, 27612, United States

Location

Pmg Research Of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Radiant Research, Inc.

Akron, Ohio, 44311, United States

Location

Cor Clinical Research

Oklahoma City, Oklahoma, 73103, United States

Location

Futuresearch Trials Of Neurology

Austin, Texas, 78731, United States

Location

Local Institution

Bordeaux, 33076, France

Location

Local Institution

Boulogne-Billancourt, 92100, France

Location

Local Institution

Nice, 06003, France

Location

Local Institution

Saint-Priest-en-Jarez, 42277, France

Location

Related Links

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 28, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2012

Study Completion

June 1, 2012

Last Updated

December 7, 2015

Record last verified: 2015-11

Locations

FR(4)US(19)