Crossover Post-herpetic Neuralgia (PHN)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Post-Herpetic Neuralgia (PHN)

Treatments: Drug: Placebo; Drug: BMS-954561

Study type: Interventional

Funder types: Industry

Identifiers

NCT01305538

CN169-002

2010-023041-30 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

Allocation: Randomized Stratified

Interventional model: Cross-over Placebo Controlled

Enrollment: 100 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Arm 1 BMS-954561 40mg or 80mg

Other group

Description:

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)

Treatment:

Drug: BMS-954561

Drug: BMS-954561

Drug: Placebo

Arm 2 BMS-954561 150mg or 300mg

Other group

Description:

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)

Treatment:

Drug: BMS-954561

Drug: BMS-954561

Drug: Placebo