Clinical Trial: A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double Blind, Randomized, Placebo-controlled, Parallel Group Study, for the Assessment of Efficacy, Safety and Tolerability of Brivaracetam at the Doses of 200 mg/Day and 400 mg/Day, in Subjects (at
Brief Summary: Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor down-titration.
Detailed Summary:
Sponsor: UCB Pharma
Current Primary Outcome: Percentage change in average pain intensity score (11-point Likert scale) from baseline to the last week of the 4-week treatment period [ Time Frame: Baseline, last week of the 4-week treatment period ]
Original Primary Outcome: To evaluate the reduction in the average pain intensity score on an 11-point numerical pain rating scale from the Baseline Period to the last week of the Treatment Period (4 weeks).
Current Secondary Outcome:
- 30% responder rate based on percent change in average pain intensity score (11-point Likert scale) from baseline to the last week of the 4-week treatment period [ Time Frame: Last week of the 4-week treatment period ]30% responder rate based on percent change in average pain intensity score (11-point Likert scale) from baseline to the last week of the 4-week treatment period
- Percentage change in sleep interference score (11-point Likert scale) from baseline to the last week of the 4-week treatment period [ Time Frame: Baseline, last week of the 4-week treatment period ]Percentage change in sleep interference score (11-point Likert scale) from baseline to the last week of the 4-week treatment period
- Absolute change in total pain score based on the Short-Form McGill Pain Questionnaire (SF-MPQ) from baseline to last assessment during the 4-week treatment period [ Time Frame: Baseline, last assessment during the 4-week treatment period ]Absolute change in total pain score based on the Short-Form McGill Pain Questionnaire (SF-MPQ) from baseline to last assessment during the 4-week treatment period
- Patient's Global Evaluation Scale (GES) at the end of the 4-week treatment period [ Time Frame: Last assessment during the 4-week treatment period ]Patient's Global Evaluation Scale (GES) at the end of the 4-week treatment period
- Investigator's Global Evaluation Scale (GES) at the end of the 4-week treatment period [ Time Frame: Last assessment during the 4-week treatment period ]Investigator's Global Evaluation Scale (GES) at the end of the 4-week treatment period
- Percent change in brush evoked allodynia intensity (11-point Likert scale) from baseline to the end of the 4-week treatment period [ Time Frame: Baseline, last assessment during the 4-week treatment period ]Percent change in brush evoked allodynia intensity (11-point Likert scale) from baseline to the end of the 4-week treatment period
- Percentage change in brush evoked allodynia surface area (body, face) from baseline to the end of the 4-week treatment period [ Time Frame: Baseline, last assessment during the 4-week treatment period ]Percentage change in brush evoked allodynia surface area (body, face) from baseline to the end of the 4-week treatment period
Original Secondary Outcome:
- o Change in the Sleep Interference Score (11-point numerical sleep interference rating scale from the Baseline Period to the last week of the Treatment Period (4 weeks).
- o Absolute change from the Randomization visit to the Evaluation/Early Discontinuation visit, in each score of the SF-MPQ.
- o Reduction in the brush-evoked allodynia intensity and area from the Randomization Visit to the Evaluation/Early Discontinuation visit (4 weeks).
- o Safety and tolerability of Brivaracetam in PHN.
Information By: UCB Pharma
Dates:
Date Received: September 8, 2005
Date Started: October 2004
Date Completion:
Last Updated: October 15, 2010
Last Verified: October 2010