drugset / Trial / NCT00160667

A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)

NCT00160667 ↗

Phase 2 Completed 152 enrolled UCB Pharma
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2004-10-11
Primary completion
2006-01-05
Completion
2006-01-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Brivaracetam 200 mg/Day; p =0.965; Mean Difference (Final Values) 0.29 (95% CI -12.82 to 13.41); ANCOVA NCT00160667 ↗

registry analysis (superiority or other test); Placebo vs Brivaracetam 400 mg/Day; p =0.825; Mean Difference (Final Values) 1.48 (95% CI -11.69 to 14.65); ANCOVA NCT00160667 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Brivaracetam Small molecule 200 mg Oral
Subject Brivaracetam Small molecule 400 mg Oral