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CompletedNCT01305538Updated Dec 7, 2015

Crossover Post-herpetic Neuralgia (PHN)

A Phase 2 interventional study of BMS-954561 and BMS-954561 in Post-Herpetic Neuralgia (PHN), sponsored by Bristol-Myers Squibb. Completed at 23 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-12-07.

Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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).

Read the detailed description

Allocation: Randomized Stratified

Interventional model: Cross-over Placebo Controlled

02

Conditions studied

  • Post-Herpetic Neuralgia (PHN)
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 100 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Other
    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 · Drug: Placebo

  • Other
    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 · Drug: Placebo

Interventions

  • DrugBMS-954561
  • DrugBMS-954561
  • DrugPlacebo
06

What researchers measure

Primary outcomes

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

    Time frame: up to 10 weeks

Secondary outcomes

  1. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Screening/Baseline Phase: Baseline

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

07

Study locations

23 sites
  • Arizona Research Center
    Phoenix, Arizona 85023, United States
  • Torrance Clinical Research
    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 Cedex, 33076, France
  • Local Institution
    Boulogne-Billancourt, 92100, France
  • Local Institution
    Nice Cedex 1, 06003, France
  • Local Institution
    Saint Priest En Jarez, 42277, France
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01305538
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Feb 28, 2011
Start date
Mar 2011
Primary completion
Feb 2012
Completion
Jun 2012
Last update
Dec 7, 2015

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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