Action of Amantadine on Post-Stroke Aphasic Patients (CELIC-1)

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cerebral Infarction

Treatments: Drug: Amantadin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00821691

01-APN-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

1

Other group

Description:

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)

Treatment:

Drug: Amantadin

Drug: Placebo

2

Other group

Description:

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)

Treatment:

Drug: Amantadin

Drug: Placebo