ACTION OF THE AMANTADINE ON POST STROKE APHASIC PATIENTS LANGUAGE AND COMMUNICATION - CELIC-1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003945-10-FR

Enrollment

Registered

2009-03-12

Start date

2009-01-20

Completion date

Unknown

Last updated

2022-08-08

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

Conditions

post stroke chronic aphasia patients

Interventions

Trade Name: Mantadix Product Name: mantadix Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - RANKIN 18 years and six month - stable treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 (<2mois) cognitives. - pregnant or lactating

Design outcomes

Primary

Measure	Time frame
Main Objective: To confirm by a «drug test", using amantadine as dopamine agonist, 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).;Secondary Objective: to codify a drug test to be included in the" recommendations "to take care of these patients. - to establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment. - to identify extra linguistic components of communication influenced by the amantadine. ;Primary end point(s): number of correctly enonce by patient during fluence verbale test.	—

Measure

Time frame

Main Objective: To confirm by a «drug test", using amantadine as dopamine agonist, 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).;Secondary Objective: to codify a drug test to be included in the" recommendations "to take care of these patients. - to establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment. - to identify extra linguistic components of communication influenced by the amantadine. ;Primary end point(s): number of correctly enonce by patient during fluence verbale test.

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026