Post-Herpetic Neuralgia (PHN)
Conditions
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
Interventions
DRUGBMS-954561
DRUGPlacebo
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo. | up to 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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, on the Patient Global Impression of Change (PGIC) scale. | Double-blind Treatment Phase: Weeks 1 |
| 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 |
Countries
France, United States
Outcome results
None listed