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Fluoxetine on Motor Rehabilitation After Ischemic Stroke (FLAME)

Primary Purpose

Ischemic Stroke, Motor Impairment

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
fluoxetine
placebo
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring 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

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital
  • University Hospital René Dubos
  • University Hospital
  • University Hospital
  • University Hospital
  • University Hospital Pitié Salpétrière
  • University Hospital Sainte Anne
  • University Hospital Rangueil
  • University Hospital Purpan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

fluoxetine

Placebo

Outcomes

Primary Outcome Measures

Progression in the Fugl-Meyer Motor Scale

Secondary Outcome Measures

Fugl-Meyer Stroke Scale
NIH stroke scale
MADRS depression scale
Modified Rankin scale
Mortality

Full Information

First Posted
April 8, 2008
Last Updated
September 15, 2011
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT00657163
Brief Title
Fluoxetine on Motor Rehabilitation After Ischemic Stroke
Acronym
FLAME
Official Title
Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Motor Impairment
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
fluoxetine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
fluoxetine
Other Intervention Name(s)
PROZAC
Intervention Description
fluoxetine per os 20 mg daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo per os daily
Primary Outcome Measure Information:
Title
Progression in the Fugl-Meyer Motor Scale
Time Frame
M3 (3 months)
Secondary Outcome Measure Information:
Title
Fugl-Meyer Stroke Scale
Time Frame
M12 (12 months)
Title
NIH stroke scale
Time Frame
M3 and M12
Title
MADRS depression scale
Time Frame
M3 and M12
Title
Modified Rankin scale
Time Frame
M3 and M12
Title
Mortality
Time Frame
M3 and M12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Chollet, PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
University Hospital René Dubos
City
Cergy-Pontoise
ZIP/Postal Code
95303
Country
France
Facility Name
University Hospital
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
University Hospital
City
Grenoble
ZIP/Postal Code
38048
Country
France
Facility Name
University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
University Hospital Pitié Salpétrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
University Hospital Sainte Anne
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
University Hospital Rangueil
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
University Hospital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
11761469
Citation
Pariente J, Loubinoux I, Carel C, Albucher JF, Leger A, Manelfe C, Rascol O, Chollet F. Fluoxetine modulates motor performance and cerebral activation of patients recovering from stroke. Ann Neurol. 2001 Dec;50(6):718-29. doi: 10.1002/ana.1257.
Results Reference
background
PubMed Identifier
8685930
Citation
Dam M, Tonin P, De Boni A, Pizzolato G, Casson S, Ermani M, Freo U, Piron L, Battistin L. Effects of fluoxetine and maprotiline on functional recovery in poststroke hemiplegic patients undergoing rehabilitation therapy. Stroke. 1996 Jul;27(7):1211-4. doi: 10.1161/01.str.27.7.1211.
Results Reference
background
PubMed Identifier
21216670
Citation
Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7. Erratum In: Lancet Neurol. 2011 Mar;10(3):205.
Results Reference
derived

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Fluoxetine on Motor Rehabilitation After Ischemic Stroke

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