drugset / Trial / NCT01124097

Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia

NCT01124097 ↗

Phase 3 Terminated 240 enrolled Bial - Portela C S.A.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2010-09
Primary completion
2012-04
Completion
2012-04

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Esl 800 mg Once Daily (QD) vs Placebo; p = 0.9321; Dunnett's test NCT01124097 ↗

registry analysis (superiority or other test); Esl 1200 mg QD vs Placebo; p = 0.2610; Dunnett's test NCT01124097 ↗

registry analysis (superiority or other test); Esl 1600 mg QD vs Placebo; p = 0.4764; Dunnett's test NCT01124097 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Eslicarbazepine acetate Unknown 800 mg —
Subject Eslicarbazepine acetate Unknown 1200 mg —
Subject Eslicarbazepine acetate Unknown 1600 mg —