Action of Amantadine on Post-Stroke Aphasic Patients
- Conditions
- Cerebral Infarction
- Interventions
- Drug: AmantadinDrug: Placebo
- Registration Number
- NCT00821691
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Brief Summary
The objective of the study is to test the action of the amantadine, as DOPA-agonist, in a double blind cross-over trial, amantadine / placebo, on the verbal fluency of chronic post stroke aphasic patients.
- Detailed Description
In France, there are around 30000 aphasic patients. The actual taking care of these patients after stroke includes the treatment of acute stage in stroke unit, followed by rehabilitation program. However, most non fluent aphasic patients remain chronically handicapped despite of intensive logopedic training.
The objective of this clinical project is to test the action of pharmacologic agents on verbal fluency of aphasic patients victims of cerebral infarctions. Only a few studies have been done with various pharmacologic agents, and although the results were not clearly conclusive, they were sufficiently positive for suggesting to launch a well controlled randomized cross-over study.
Then the objective of study is to test the action of the amantadine, as DOPA-agonist, in a double blind cross-over trial, amantadine / placebo, on the verbal fluency of chronic post stroke aphasic patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- RANKIN < 3
- > 18 years and < 75
- francophone
- within cognitive deficit known before stroke
- stroke, single in sylvian artery area
- aphasia " non fluent " following a stroke
- stroke > six month
- stable treatment
- RANKIN > 3
- non francophone
- do not read nor write
- many stroke - against indication
- participated in another clinical trial
- deaf or blind
- intercurrent disease
- new treatment (< 2 months) cognitive
- pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Amantadin Amantadin - Placebo: 5 amantadin caps - 4 days wash out - 5 placebo caps 5 amantadin caps (100mg); 2 caps a day during 3 days; after wash out period (4 days): 5 placebo caps (2 caps a day during 3 days) 1 Placebo Amantadin - Placebo: 5 amantadin caps - 4 days wash out - 5 placebo caps 5 amantadin caps (100mg); 2 caps a day during 3 days; after wash out period (4 days): 5 placebo caps (2 caps a day during 3 days) 2 Amantadin Placebo - Amantadin: 5 placebo caps - 4 days wash out - 5 amantadin caps 5 placebo caps: 2 caps a day during 3 days after wash out period (4 days): 5 amantadin caps(100mg) (2 caps a day during 3 days) 2 Placebo Placebo - Amantadin: 5 placebo caps - 4 days wash out - 5 amantadin caps 5 placebo caps: 2 caps a day during 3 days after wash out period (4 days): 5 amantadin caps(100mg) (2 caps a day during 3 days)
- Primary Outcome Measures
Name Time Method Confirm that the possibility of significantly improving the verbal fluency and communication of patients with "not fluent" aphasia at the chronic stage when logopedic rehabilitation is "stabilized" (> 6months). 2 years
- Secondary Outcome Measures
Name Time Method Codify a drug test to be included in the" recommendations "to take care of these patients 2 years Establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment 2 years Identify extra linguistic components of communication influenced by amantadine 2 years
Trial Locations
- Locations (6)
University hospital of Bordeaux
🇫🇷Bordeaux, France
CHU Limoges
🇫🇷Limoges, France
CHU de Dijon
🇫🇷Dijon, France
CHU de Nice
🇫🇷Nice, France
CH Saint Pierre La Réunion
🇫🇷Saint Pierre, Ile de La Réunion, France
CHU Rennes
🇫🇷Rennes, France