Fluoxetine on Motor Rehabilitation After Ischemic Stroke (FLAME)

Toulouse University Hospital

Status and phase

Completed

Phase 2

Conditions

Ischemic Stroke

Motor Impairment

Treatments

Drug: placebo

Drug: fluoxetine

Study type

Interventional

Funder types

Other

Identifiers

NCT00657163

French PHRC (Other Grant/Funding Number)

0300501

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.