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NCT Number: NCT00821691

Action of Amantadine on Post-Stroke Aphasic Patients

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.

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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CH Saint Pierre La Réunion, Saint-Pierre, Ile de La Réunion, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amantadin

Drug

Amantadin caps

Placebo

Drug

Placebo caps

Primary outcomes

  1. 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

  1. Codify a drug test to be included in the" recommendations "to take care of these patients

    Time frame: 2 years

  2. Establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment

    Time frame: 2 years

  3. Identify extra linguistic components of communication influenced by amantadine

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: CELIC-1

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 13, 2009
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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