NCT00657163

Fluoxetine on Motor Rehabilitation After Ischemic Stroke

Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.

Detailed description

We project to include in the study a maximum of 168 patients with a recent (5 to 10 days) ischemic stroke and unilateral motor deficit in order to obtain 100 completed patients. Nine stroke centers in France are involved. Each patient will receive daily, during three months, 20 mg of fluoxetin or placebo. Patients will be evaluated at inclusion, day 30, M3 (3 months), M12.

Conditions

• Ischemic Stroke
• Motor Impairment

Interventions

Type	Name	Description
DRUG	fluoxetine	fluoxetine per os 20 mg daily
DRUG	placebo	placebo per os daily

Timeline

• Start date: 2005-03-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-04-14
• Last updated: 2011-09-16

Locations

9 sites across 1 country: France