Fluoxetine on Motor Rehabilitation After Ischemic Stroke "FLAME"

Completed

Phase 2 Results N/A

Trial Description

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

Interventions

  • Fluoxetine (Prozac®)Drug
    Other Names: Patients receiving fluoxetine
    Intervention Desc: fluoxetine per os 20 mg daily
    ARM 1: Kind: Experimental
    Label: 1
    Description: fluoxetine
  • Placebo Drug
    Intervention Desc: placebo per os daily
    ARM 1: Kind: Experimental
    Label: 2
    Description: Placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Progression in the Fugl-Meyer Motor Scale
Secondary Fugl-Meyer Stroke Scale, NIH stroke scale, MADRS depression scale, Modified Rankin scale, & Mortality.
Secondary Fugl-Meyer Stroke Scale M12 (12 months) No
Secondary NIH stroke scale M3 and M12 No
Secondary MADRS depression scale M3 and M12 No
Secondary Modified Rankin scale M3 and M12 No
Secondary Mortality M3 and M12 Yes

Sponsors