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Fluoxetine on Motor Rehabilitation After Ischemic Stroke (FLAME)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00657163
First received: April 8, 2008
Last updated: September 15, 2011
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
Motor Impairment
Drug: fluoxetine
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Progression in the Fugl-Meyer Motor Scale [ Time Frame: M3 (3 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fugl-Meyer Stroke Scale [ Time Frame: M12 (12 months) ] [ Designated as safety issue: No ]
  • NIH stroke scale [ Time Frame: M3 and M12 ] [ Designated as safety issue: No ]
  • MADRS depression scale [ Time Frame: M3 and M12 ] [ Designated as safety issue: No ]
  • Modified Rankin scale [ Time Frame: M3 and M12 ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: M3 and M12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
fluoxetine
Drug: fluoxetine
fluoxetine per os 20 mg daily
Other Name: PROZAC
Placebo Comparator: 2
Placebo
Drug: placebo
placebo per os daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657163

Locations
France
University Hospital
Besançon, France, 25030
University Hospital René Dubos
Cergy-Pontoise, France, 95303
University Hospital
Dijon, France, 21000
University Hospital
Grenoble, France, 38048
University Hospital
Nantes, France, 44093
University Hospital Pitié Salpétrière
Paris, France, 75651
University Hospital Sainte Anne
Paris, France, 75674
University Hospital Purpan
Toulouse, France, 31059
University Hospital Rangueil
Toulouse, France, 31052
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: François Chollet, PhD University Hospital, Toulouse
  More Information

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00657163     History of Changes
Other Study ID Numbers: 0300501, French PHRC
Study First Received: April 8, 2008
Last Updated: September 15, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Stroke recovery
Pharmacological modulation
Selective Serotonin Reuptake Inhibitor (SSRI)
Fluoxetine
Brain plasticity
Ischemic Stroke and Motor impairment
Modulation of recovery and cerebral plasticity by Fluoxetine

Additional relevant MeSH terms:
Fluoxetine
Cerebral Infarction
Ischemia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Serotonin Uptake Inhibitors
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014