Clinical trial NCT00821691: Action of Amantadine on Post-Stroke Aphasic Patients
Official title: Action of the Amantadine on Post Stroke Aphasic Patients' Language and Communication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cerebral Infarction
Keywords: cerebral infarction
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2009-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 2 years
Secondary outcomes:
measure: Codify a drug test to be included in the" recommendations "to take care of these patients
timeFrame: 2 years
measure: Establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment
timeFrame: 2 years
measure: Identify extra linguistic components of communication influenced by amantadine
timeFrame: 2 years
Other outcomes:
Locations:
city: Saint Pierre
country: France
facility: CH Saint Pierre La Réunion
state: Ile de La Réunion
city: Bordeaux
country: France
facility: University hospital of Bordeaux
city: Dijon
country: France
facility: CHU de Dijon
city: Limoges
country: France
facility: CHU Limoges
city: Nice
country: France
facility: CHU de Nice
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: University hospital of Nice
name: Marcel CHATEL, MDPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University hospital of Nice
name: Hélène MAHAGNE, PH
role: STUDY_DIRECTOR
affiliation: University hospital of Nice
name: Sylvain LACHAUD, PH
role: STUDY_DIRECTOR
References: