Clinical Trial: Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Post-Herpetic Neuralgia
Brief Summary: The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate (ESL) as therapy in subjects with Post-herpetic Neuralgia (PHN) over a 15 week treatment phase.
Detailed Summary:
Post-herpetic neuralgia (PHN) is a syndrome of intractable pain following an acute infection of herpes zoster (shingles).
Treatment for PHN is often suboptimal. More than 50% of the subjects fail to respond to pharmacological treatments or experience intolerable side effects.
The clinical development of ESL to treat neuropathic pain is based on its chemical and pharmacodynamic relationship to sodium channel blockers, including carbamazepine, which is effective for treating some neuropathic pain conditions. Preclinical data supports the theoretical background.
This study will examine the efficacy, safety, tolerability and pharmacokinetics of Eslicarbazepine acetate for the treatment of post herpetic neuralgia.
Sponsor: Bial - Portela C S.A.
Current Primary Outcome: Change From Baseline to Endpoint in Mean Pain [ Time Frame: baseline to endpoint ]
The efficacy analysis was restricted to the primary efficacy variable in the analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (October 31, 2011), was the basis for the analysis.
The primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 ["0" = no pain; "10" = the most intense pain imaginable]
Original Primary Outcome: To assess the efficacy of ESL as therapy in subjects with Post Herpetic Neuralgia [ Time Frame: 12 weeks ]
Current Secondary Outcome:
Original Secondary Outcome:
- Worst daily pain and worst night pain (change from Baseline to endpoint in worst daily pain and night pain is defined in the same way as the primary efficacy endpoint). [ Time Frame: 12 weeks ]
- Weekly mean pain intensity (calculated from the 11-point NRPS). [ Time Frame: 12 weeks ]
- Responder rates (reduction of at least 30% or at least 50% compared with baseline based on the 11-point NRPS average pain score). [ Time Frame: 12 weeks ]
- Time to response (time in days to the first of 2 consecutive days after randomization with average pain score at least 2 points below baseline mean pain, based on the 11-point NRPS average pain score). [ Time Frame: 12 weeks ]
- Patient and clinical global impression of change (subjects rate their change in the overall status answering the question on the scale). [ Time Frame: 12 weeks ]
- Short Form McGill Pain Questionnaire (subjects complete this questionnaire as a qualitative assessment of their pain and their affective response to pain). [ Time Frame: 12 weeks ]
- Allodynia Visual Analog Scale (subjects rate the allodynia severity after mechanic allodynia evoked pain). [ Time Frame: 12 weeks ]
- Chronic Pain Sleep Inventory (subjects complete this inventory to assess the impact of their pain on sleep). [ Time Frame: 12 Weeks ]
- Rescue medication use (number of days from first intake of double-blind study drug to first intake of rescue medication and the mean amount of paracetamol per study day will be derived). [ Time Frame: 12 weeks ]
Information By: Bial - Portela C S.A.
Dates:
Date Received: May 3, 2010
Date Started: September 2010
Date Completion:
Last Updated: February 26, 2014
Last Verified: February 2014
