StrokeFLANNCT01674868
Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke
A study testing fluoxetine in people with Stroke, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American sample of post-acute stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- fluoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2015
- Phase
- Interventional
- 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
- Ischemic infarction within 15 days
- Admission NIHSS item 5 score equal to or >2 -Able to give informed consent, with surrogate consent acceptable-
Who cannot join
- Pre-stroke modified Rankin Scale score equal or .3
- Pregnant or lactating
- Taking an SSRI on admission to SRH
- Taking a medication likely to have adverse interaction with an SSRI
- Unable to return for follow-up testing days 90,180
- Concurrent medial condition likely to worsen patient's functional status over next 6 months
- Unable to competently participate in testing for 45min-2hrs with rest breaks
- for MRI substudy: contraindication to MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot RCT of Fluoxetine vs Placebo to Treat Motor, Language and Unilateral Neglect After Ischemic Stroke
This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American sample of post-acute stroke patients. This trial will in addition examine the effect of treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial attention, as well as post-stroke fatigue and will evaluate the durability of observed effects. The results of this pilot trial will be used to develop power estimates for a larger trial and to evaluate recruitment and intervention completion rates for subjects in an American post-acute environment. There are two additional substudies: the first will use MRI to assess structural changes at the beginning and end of the intervention; the second will examine the relationship of serum biomarkers of inflammation to the intervention.
- Conditions
- Stroke
- Being tested
- fluoxetine, placebo
- Keywords
- stroke, recovery, fluoxetine, aphasia, neglect, motor
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoxetineDrug
20 mg daily for 90 days starting day 5-10 after stroke.
placeboDrug
subjects will take one pill po daily for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Experimental | Subjects will take 20 mg fluoxetine daily for 90 days after stroke Receives: Drug: fluoxetine |
| placebo | Placebo comparator | Subjects will take one pill daily for 90 days after stroke. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Motor Scale (FMMS)
change in FMMS score
Measured: baseline to 90 days
Fugl-Meyer Motor Scale (FMMS)
change in FMMS
Measured: baseline to 180 days
Secondary outcomes (11)
Western Aphasia Battery
change in Western Aphasia Quotient
Measured: baseline to 90 days
Behavioral Inattention Test (BIT)
change in BIT
Measured: baseline to 90 days
Behavioral Inattention Test (BIT)
change in BIT
Measured: baseline to 180 days
Functional Independence Measure
change in FIM
Measured: baseline to discharge
Fatigue Severity Scale
Measured: baseline to 90 days
Beck Depression Inventory
Measured: baseline to 90 days
Western Aphasia Battery
change in Western Aphasia Quotient
Measured: baseline to 180 days
Beck Depression Inventory
Measured: baseline to 180 days
Fatigue Severity Scale
Measured: baseline to 180 days
modified Rankin Scale
Measured: baseline to 90 days
modified Rankin Scale
Measured: baseline to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startApr 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: unable to find patients meeting inclusion/exclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randie Black-Schaffer MD, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674868
- Sponsor's protocol ID
- FLAN SpauldingRH
- Acronym
- FLAN
- Status last verified
- Jun 2015
- First submitted
- 24 Aug 2012
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot RCT of Fluoxetine vs Placebo to Treat Motor, Language and Unilateral Neglect After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01674868
- Acronym / sponsor ID
- FLAN / FLAN SpauldingRH
- Conditions
- Stroke
- Keywords
- stroke, recovery, fluoxetine, aphasia, neglect, motor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to find patients meeting inclusion/exclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 Aug 2012 (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.
This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American sample of post-acute stroke patients. This trial will in addition examine the effect of treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial attention, as well as post-stroke fatigue and will evaluate the durability of observed effects. The results of this pilot trial will be used to develop power estimates for a larger trial and to evaluate recruitment and intervention completion rates for subjects in an American post-acute environment. There are two additional substudies: the first will use MRI to assess structural changes at the beginning and end of the intervention; the second will examine the relationship of serum biomarkers of inflammation to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Experimental | Drug: fluoxetineSubjects will take 20 mg fluoxetine daily for 90 days after stroke |
| placebo | Placebo comparator | Drug: placeboSubjects will take one pill daily for 90 days after stroke. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ischemic infarction within 15 days
- Admission NIHSS item 5 score equal to or >2 -Able to give informed consent, with surrogate consent acceptable-
Key exclusion criteria (8 listed)
- Pre-stroke modified Rankin Scale score equal or .3
- Pregnant or lactating
- Taking an SSRI on admission to SRH
- Taking a medication likely to have adverse interaction with an SSRI
- Unable to return for follow-up testing days 90,180
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 |
|---|---|---|
| fluoxetine20 mg daily for 90 days starting day 5-10 after stroke. | Drug | Fluoxetine |
| placebosubjects will take one pill po daily for 90 days. | Drug | placebo |
Primary outcome
Fugl-Meyer Motor Scale (FMMS)
Time frame: baseline to 90 days
change in FMMS score
Fugl-Meyer Motor Scale (FMMS)
Time frame: baseline to 180 days
change in FMMS
11 secondary outcomes
Western Aphasia Battery
Time frame: baseline to 90 days
Behavioral Inattention Test (BIT)
Time frame: baseline to 90 days
Behavioral Inattention Test (BIT)
Time frame: baseline to 180 days
Functional Independence Measure
Time frame: baseline to discharge
Fatigue Severity Scale
Time frame: baseline to 90 days
Beck Depression Inventory
Time frame: baseline to 90 days
Western Aphasia Battery
Time frame: baseline to 180 days
Beck Depression Inventory
Time frame: baseline to 180 days
Fatigue Severity Scale
Time frame: baseline to 180 days
modified Rankin Scale
Time frame: baseline to 90 days
modified Rankin Scale
Time frame: baseline to 180 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluoxetine in people with Stroke, run by Spaulding Rehabilitation Hospital at 1 site in United States.
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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Fugl-Meyer Motor Scale (FMMS) (time frame: baseline to 90 days). The study lists 2 primary outcomes in all. 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 16 Jun 2015.