Ischemic StrokePhase 2FLAMENCT00657163
Fluoxetine on Motor Rehabilitation After Ischemic Stroke
A Phase 2 study testing fluoxetine in people with Ischemic Stroke and Motor Impairment, run by University Hospital, Toulouse at 9 sites in France.
Trial summary
Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke, Motor Impairment
- What is being tested?
- fluoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 9 sitesFrance
- Study dates
- Mar 2005to Dec 2010
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged from 18 to 85
- No motor relapse from a previous stroke
- Ischemic stroke with unilateral motor deficit
- Motor NIHSS ≥ 5 on the affected side of the body
- NIHSS < 20
- Fugl Meyer Motor Scale <55
- Modified Rankin Scale between 1 and 5
- Informed consent obtained from the subject or a member of his family
Who cannot join
- Pregnant or breast-feeding woman
- Woman able to procreate without valid contraception
- Subject protected by law
- Concomitant disease with unfavourable prognosis within 1 year
- Drug addiction
- Allergy to fluoxetine
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- Hepatic failure (TGO and TGP >2N)
- Permanent Renal failure (Creatinin >180micromol/l)
- Patients treated by tricyclic antidepressant, selective serotonin reuptake inhibitor, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month
- Depression requiring pharmacological treatment
- Previous stroke with motor relapse
- Fugl Meyer Motor Scale > 55
- Modified Rankin Scale = 0 or 6
- Patients needing carotid surgery within 3 months
- Aphasia preventing correct evaluation of motor and depression scales.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
University Hospital
Besançon, 25030
University Hospital René Dubos
Cergy-Pontoise, 95303
University Hospital
Dijon, 21000
University Hospital
Grenoble, 38048
University Hospital
Nantes, 44093
University Hospital Pitié Salpétrière
Paris, 75651
University Hospital Sainte Anne
Paris, 75674
University Hospital Rangueil
Toulouse, 31052
University Hospital Purpan
Toulouse, 31059
About this study
Official title: Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial
Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.
Read the detailed description
We project to include in the study a maximum of 168 patients with a recent (5 to 10 days) ischemic stroke and unilateral motor deficit in order to obtain 100 completed patients. Nine stroke centers in France are involved.
Each patient will receive daily, during three months, 20 mg of fluoxetin or placebo.
Patients will be evaluated at inclusion, day 30, M3 (3 months), M12.
- Conditions
- Ischemic Stroke, Motor Impairment
- Being tested
- fluoxetine, placebo
- Keywords
- Stroke recovery, Pharmacological modulation, Selective Serotonin Reuptake Inhibitor (SSRI), Fluoxetine, Brain plasticity, Ischemic Stroke and Motor impairment, Modulation of recovery and cerebral plasticity by Fluoxetine
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoxetineDrug
Also called PROZAC
fluoxetine per os 20 mg daily
placeboDrug
placebo per os daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | fluoxetine Receives: Drug: fluoxetine |
| 2 | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression in the Fugl-Meyer Motor Scale
Measured: M3 (3 months)
Secondary outcomes (5)
Fugl-Meyer Stroke Scale
Measured: M12 (12 months)
NIH stroke scale
Measured: M3 and M12
MADRS depression scale
Measured: M3 and M12
Modified Rankin scale
Measured: M3 and M12
Mortality
Measured: M3 and M12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMar 2005
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Chollet, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657163
- Sponsor's protocol ID
- 0300501
- Other IDs
- French PHRC
- Acronym
- FLAME
- Status last verified
- Jul 2009
- First submitted
- 8 Apr 2008
- Last updated
- 16 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Pariente J, Loubinoux I, Carel C, Albucher JF, Leger A, Manelfe C, Rascol O, Chollet F. Fluoxetine modulates motor performance and cerebral activation of patients recovering from stroke. Ann Neurol. 2001 Dec;50(6):718-29. doi: 10.1002/ana.1257.
PubMed 11761469Dam M, Tonin P, De Boni A, Pizzolato G, Casson S, Ermani M, Freo U, Piron L, Battistin L. Effects of fluoxetine and maprotiline on functional recovery in poststroke hemiplegic patients undergoing rehabilitation therapy. Stroke. 1996 Jul;27(7):1211-4. doi: 10.1161/01.str.27.7.1211.
PubMed 8685930Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7.
PubMed 21216670
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial
- ClinicalTrials.gov ID
- NCT00657163
- Acronym / sponsor ID
- FLAME / 0300501
- Conditions
- Ischemic Stroke, Motor Impairment
- Keywords
- Stroke recovery, Pharmacological modulation, Selective Serotonin Reuptake Inhibitor (SSRI), Fluoxetine, Brain plasticity, Ischemic Stroke and Motor impairment, Modulation of recovery and cerebral plasticity by Fluoxetine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Apr 2008 (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.
Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.
Detailed description
We project to include in the study a maximum of 168 patients with a recent (5 to 10 days) ischemic stroke and unilateral motor deficit in order to obtain 100 completed patients. Nine stroke centers in France are involved.
Each patient will receive daily, during three months, 20 mg of fluoxetin or placebo.
Patients will be evaluated at inclusion, day 30, M3 (3 months), M12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: fluoxetinefluoxetine |
| 2 | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged from 18 to 85
- No motor relapse from a previous stroke
- Ischemic stroke with unilateral motor deficit
- Motor NIHSS ≥ 5 on the affected side of the body
- NIHSS < 20
Key exclusion criteria (15 listed)
- Pregnant or breast-feeding woman
- Woman able to procreate without valid contraception
- Subject protected by law
- Concomitant disease with unfavourable prognosis within 1 year
- Drug addiction
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 |
|---|---|---|
| fluoxetineAlso: PROZACfluoxetine per os 20 mg daily | Drug | 1 |
| placeboplacebo per os daily | Drug | 2 |
Primary outcome
Progression in the Fugl-Meyer Motor Scale
Time frame: M3 (3 months)
5 secondary outcomes
Fugl-Meyer Stroke Scale
Time frame: M12 (12 months)
NIH stroke scale
Time frame: M3 and M12
MADRS depression scale
Time frame: M3 and M12
Modified Rankin scale
Time frame: M3 and M12
Mortality
Time frame: M3 and M12
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 16 Sep 2011.
- Background: PubMed 11761469Pariente J, Loubinoux I, Carel C, Albucher JF, Leger A, Manelfe C, Rascol O, Chollet F. Fluoxetine modulates motor performance and cerebral activation of patients recovering from stroke. Ann Neurol. 2001 Dec;50(6):718-29. doi: 10.1002/ana.1257.
- Background: PubMed 8685930Dam M, Tonin P, De Boni A, Pizzolato G, Casson S, Ermani M, Freo U, Piron L, Battistin L. Effects of fluoxetine and maprotiline on functional recovery in poststroke hemiplegic patients undergoing rehabilitation therapy. Stroke. 1996 Jul;27(7):1211-4. doi: 10.1161/01.str.27.7.1211.
- Derived from this study: PubMed 21216670Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7.
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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.
François Chollet, PhD principal investigator
University Hospital, Toulouse
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluoxetine in people with Ischemic Stroke and Motor Impairment, run by University Hospital, Toulouse at 9 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 15 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 16 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Progression in the Fugl-Meyer Motor Scale (time frame: M3 (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00657163, which also lists 3 linked publications.
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 16 Sep 2011.