Conditions: Painful Diabetic Neuropathy
Keywords: pain diabetes neuropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 557
Healthy volunteers: no

Brief summary:
The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy.

Detailed description:

Arms:
arm 1: ESL 400 mg twice daily (BID) arm 2: ESL 800 mg once-daily (QD) arm 3: Eslicarbazepine 600 mg twice daily arm 4: Eslicarbazepine acetate 1200 mg once daily arm 5: Eslicarbazepine acetate 800 mg twice daily arm 6: Placebo

Interventions: intervention 1: Eslicarbazepine acetate intervention 2: Placebo
Intervention descriptions: intervention 1: Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. intervention 2: oral route

Protocol document: