Fluoxetine on Motor Rehabilitation After Ischemic Stroke

Phase 2

Completed

• Conditions: Ischemic Stroke; Motor Impairment
• Interventions: Drug: placebo; Drug: fluoxetine

• Registration Number: NCT00657163
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-14
• Status Verified: 2009-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2011-09-15
• Last Update Posted: 2011-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Men and women aged from 18 to 85
• No motor relapse from a previous stroke
• Inclusion from day 5 to day 10 after stroke
• Ischemic stroke with unilateral motor deficit
• Motor NIHSS ≥ 5 on the affected side of the body
• NIHSS < 20
• Fugl Meyer Motor Scale <55
• Modified Rankin Scale between 1 and 5
• Informed consent obtained from the subject or a member of his family

Exclusion Criteria

• Pregnant or breast-feeding woman
• Woman able to procreate without valid contraception
• Subject protected by law
• Concomitant disease with unfavourable prognosis within 1 year
• Drug addiction
• Allergy to fluoxetine
• Hepatic failure (TGO and TGP >2N)
• Permanent Renal failure (Creatinin >180micromol/l)
• Patients treated by tricyclic antidepressant, selective serotonin reuptake inhibitor, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month
• Depression requiring pharmacological treatment
• Previous stroke with motor relapse
• Fugl Meyer Motor Scale > 55
• Modified Rankin Scale = 0 or 6
• Patients needing carotid surgery within 3 months
• Aphasia preventing correct evaluation of motor and depression scales.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	Placebo
1	fluoxetine	fluoxetine

Primary Outcome Measures

Name	Time	Method
Progression in the Fugl-Meyer Motor Scale	M3 (3 months)

Secondary Outcome Measures

Name	Time	Method
Mortality	M3 and M12
Fugl-Meyer Stroke Scale	M12 (12 months)
NIH stroke scale	M3 and M12
Modified Rankin scale	M3 and M12
MADRS depression scale	M3 and M12

Trial Locations

Locations (6)

University Hospital René Dubos; 🇫🇷 Cergy-Pontoise, France

University Hospital Sainte Anne; 🇫🇷 Paris, France

University Hospital Pitié Salpétrière; 🇫🇷 Paris, France

University Hospital Rangueil; 🇫🇷 Toulouse, France

University Hospital Purpan; 🇫🇷 Toulouse, France

University Hospital; 🇫🇷 Nantes, France