Conditions: Diabetic Neuropathy
Keywords: Diabetic neuropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 352
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy.

Detailed description:
This is a randomized, double-blind, placebo-controlled, parallel-group study. This is a 5-arm, 21-week study comprised of up to a 2-week Screening period, a 15-week Dose-Escalation and Maintenance Phase using 4 doses of E2007 (2 mg, 4 mg, 6 mg, and 8 mg) or placebo, and a 4-week, single-blind placebo Follow-Up Phase. Patients will be randomly assigned to one of the five treatment groups. Those patients assigned to receive either 4 mg, 6 mg, or 8 mg E2007 will be escalated to the appropriate dose according to an escalation schedule. All patients will take four identical-looking tablets on a daily basis for the entire study duration for blinding purposes.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Placebo intervention 2: E2007 (2 mg) intervention 3: E2007 (4 mg) intervention 4: E2007 (6 mg) intervention 5: E2007 (8 mg)
Intervention descriptions: intervention 1: Placebo tablets, once daily, for 15 weeks (taken orally). intervention 2: Perampanel, 2 mg once daily, for 15 weeks (taken orally). intervention 3: Perampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally). intervention 4: Perampanel, 2 mg once daily for three weeks, followed by 4 mg once daily, for three weeks and 6 mg, once daily, for nine weeks (taken orally). intervention 5: Perampanel, 2 mg once daily, for three weeks, followed by 4 mg, once daily for three weeks, 6 mg once daily for three weeks and 8 mg, once daily, for six weeks (taken orally).

Protocol document: