Cerebral InfarctionPhase 2/3CELIC-1NCT00821691
Action of Amantadine on Post-Stroke Aphasic Patients
A Phase 2/3 study testing Amantadin in people with Cerebral Infarction, run by Centre Hospitalier Universitaire de Nice at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Amantadin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 6 sitesFrance
- Study dates
- Mar 2009to Apr 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- RANKIN > 3
- non francophone
- do not read nor write
- many stroke - against indication
- participated in another clinical trial
- deaf or blind
Show all 9Show fewer
- intercurrent disease
- new treatment (< 2 months) cognitive
- pregnant or lactating
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
University hospital of Bordeaux
Bordeaux
CHU de Dijon
Dijon
CHU Limoges
Limoges
CHU de Nice
Nice, 06000
CHU Rennes
Rennes
CH Saint Pierre La Réunion
Saint-Pierre, Ile de La Réunion
About this study
Official title: Action of the Amantadine on Post Stroke Aphasic Patients' Language and Communication
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.
Read the 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.
- Conditions
- Cerebral Infarction
- Being tested
- Amantadin, Placebo
- Keywords
- cerebral infarction
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmantadinDrug
Amantadin caps
PlaceboDrug
Placebo caps
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 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) Receives: Drug: Amantadin; Drug: Placebo |
| 2 | Other | 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) Receives: Drug: Amantadin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (3)
Codify a drug test to be included in the" recommendations "to take care of these patients
Measured: 2 years
Establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment
Measured: 2 years
Identify extra linguistic components of communication influenced by amantadine
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcel CHATEL, MDPH, Principal investigator, University hospital of NiceHélène MAHAGNE, PH, Study director, University hospital of NiceSylvain LACHAUD, PH, Study director, University hospital of Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821691
- Sponsor's protocol ID
- 01-APN-08
- Acronym
- CELIC-1
- Status last verified
- Jun 2013
- First submitted
- 9 Jan 2009
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action of the Amantadine on Post Stroke Aphasic Patients' Language and Communication
- ClinicalTrials.gov ID
- NCT00821691
- Acronym / sponsor ID
- CELIC-1 / 01-APN-08
- Conditions
- Cerebral Infarction
- Keywords
- cerebral infarction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Amantadin, Drug: PlaceboAmantadin - 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) |
| 2 | Other | Drug: Amantadin, Drug: PlaceboPlacebo - 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- RANKIN < 3
- > 18 years and < 75
- francophone
- within cognitive deficit known before stroke
- stroke, single in sylvian artery area
Key exclusion criteria (9 listed)
- RANKIN > 3
- non francophone
- do not read nor write
- many stroke - against indication
- participated in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmantadinAmantadin caps | Drug | 1, 2 |
| PlaceboPlacebo caps | Drug | 1, 2 |
Primary outcome
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
3 secondary outcomes
Codify a drug test to be included in the" recommendations "to take care of these patients
Time frame: 2 years
Establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment
Time frame: 2 years
Identify extra linguistic components of communication influenced by amantadine
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel CHATEL, MDPH principal investigator
University hospital of Nice
Hélène MAHAGNE, PH study director
University hospital of Nice
Sylvain LACHAUD, PH study director
University hospital of Nice
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amantadin in people with Cerebral Infarction, run by Centre Hospitalier Universitaire de Nice at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.