Fluoxetine on Motor Rehabilitation After Ischemic Stroke (FLAME)

September 15, 2011 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • University Hospital
      • Cergy-Pontoise, France, 95303
        • University Hospital René Dubos
      • Dijon, France, 21000
        • University Hospital
      • Grenoble, France, 38048
        • University Hospital
      • Nantes, France, 44093
        • University Hospital
      • Paris, France, 75651
        • University Hospital Pitié Salpétrière
      • Paris, France, 75674
        • University Hospital Sainte Anne
      • Toulouse, France, 31052
        • University Hospital Rangueil
      • Toulouse, France, 31059
        • University Hospital Purpan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: placebo
placebo per os daily
Experimental: 1
fluoxetine
Drug: fluoxetine
fluoxetine per os 20 mg daily
Other Names:
  • PROZAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression in the Fugl-Meyer Motor Scale
Time Frame: M3 (3 months)
M3 (3 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer Stroke Scale
Time Frame: M12 (12 months)
M12 (12 months)
NIH stroke scale
Time Frame: M3 and M12
M3 and M12
MADRS depression scale
Time Frame: M3 and M12
M3 and M12
Modified Rankin scale
Time Frame: M3 and M12
M3 and M12
Mortality
Time Frame: M3 and M12
M3 and M12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: François CHOLLET, PhD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

September 16, 2011

Last Update Submitted That Met QC Criteria

September 15, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0300501
  • French PHRC (Other Grant/Funding Number: 0400401)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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