Crossover Post-herpetic Neuralgia (PHN)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01305538
• Date of registration: 14/02/2011
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Crossover Post-herpetic Neuralgia (PHN)
• Scientific 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)
• Date of first enrolment: March 2011
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01305538
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Post-Herpetic Neuralgia (PHN)

Intervention(s)

Drug: Placebo

Drug: BMS-954561

Primary Outcome(s)

The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo. [Time Frame: up to 10 weeks]

Secondary Outcome(s)

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]

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]

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]

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]

Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Time Frame: Screening/Baseline Phase: Baseline]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Secondary ID(s)

2010-023041-30

CN169-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors