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Completed

NCT Number: NCT00657163

Fluoxetine on Motor Rehabilitation After Ischemic Stroke

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Impairment Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluoxetine

Drug

fluoxetine per os 20 mg daily

Other names: PROZAC

Placebo

Drug

placebo per os daily

Primary outcomes

  1. Progression in the Fugl-Meyer Motor Scale

    Time frame: M3 (3 months)

Secondary outcomes

  1. Fugl-Meyer Stroke Scale

    Time frame: M12 (12 months)

  2. NIH stroke scale

    Time frame: M3 and M12

  3. MADRS depression scale

    Time frame: M3 and M12

  4. Modified Rankin scale

    Time frame: M3 and M12

  5. Mortality

    Time frame: M3 and M12

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: FLAME

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Apr 14, 2008
Registry last updated
Sep 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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