Action of the Amantadine on Post Stroke Aphasic Patients' Language and Communication
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 50
- Locations
- 6
- Primary Endpoint
- 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).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
1
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)
Intervention: Amantadin (Drug)
1
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)
Intervention: Placebo (Drug)
2
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)
Intervention: Amantadin (Drug)
2
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)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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).
Time Frame: 2 years
Secondary Outcomes
- 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)