NCT Number: NCT01305538
Crossover Post-herpetic Neuralgia (PHN)
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).
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Notify MeKey information
Conditions
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Local Institution, Bordeaux, France
About this study
Allocation: Randomized Stratified
Interventional model: Cross-over Placebo Controlled
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Placebo
DrugPrimary outcomes
-
The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.
Time frame: up to 10 weeks
Secondary outcomes
-
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 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 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 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 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 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 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 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 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 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 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 4
-
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: 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: 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 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 1
-
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 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, on the Patient Global Impression of Change (PGIC) scale.
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: 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 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 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 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 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 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, 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, 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 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: 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: 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.
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 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 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 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 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 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: 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: 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 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 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
-
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 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
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study 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)
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Feb 28, 2011
- Registry last updated
- Dec 7, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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