Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain

Summary

The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate (ESL) as therapy in subjects with Diabetic Neuropathic Pain (DNP) over a 15 week treatment phase.

Timeline

Start

2010-11

Primary completion

2012-04

Completion

2012-04

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Esl 1600 mg vs Placebo; p = 0.3726; Dunnett's test (analysis of covariance) NCT01129960 ↗

registry analysis (superiority or other test); Esl 1200 mg; p = 0.8034; Dunnett's test (analysis of covariance) NCT01129960 ↗

registry analysis (superiority or other test); Esl 800 mg vs Placebo; p = 0.1391; Dunnett's test (analysis of covariance) NCT01129960 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eslicarbazepine acetate	Unknown	800 mg	—
Subject	Eslicarbazepine acetate	Unknown	1200 mg	—
Subject	Eslicarbazepine acetate	Unknown	1600 mg	—

Indications