Status:
COMPLETED
Fluoxetine on Motor Rehabilitation After Ischemic Stroke
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Ischemic Stroke
Motor Impairment
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 combine...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00657163
Start Date
March 1 2005
End Date
December 1 2010
Last Update
September 16 2011
Active Locations (9)
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1
University Hospital
Besançon, France, 25030
2
University Hospital René Dubos
Cergy-Pontoise, France, 95303
3
University Hospital
Dijon, France, 21000
4
University Hospital
Grenoble, France, 38048