Action of Amantadine on Post-Stroke Aphasic Patients

Action of the Amantadine on Post Stroke Aphasic Patients' Language and Communication

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00821691

Acronym

CELIC-1

Enrollment

Registered

2009-01-13

Start date

2009-03-31

Completion date

2013-04-30

Last updated

2014-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Infarction

Keywords

cerebral infarction

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.

Interventions

DRUGAmantadin

Amantadin caps

DRUGPlacebo

Placebo caps

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026