Intracerebral HemorrhagePhase 3FMRICHNCT01737541
Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage
A Phase 3 study testing Fluoxetine in people with Intracerebral Hemorrhage and Motor Impairment, run by Universidad Autónoma de Aguascalientes at 4 sites in Mexico.
Trial summary
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will be carried out in Mexico. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Motor Impairment
- What is being tested?
- Fluoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 4 sitesMexico
- Study dates
- Nov 2012to Aug 2014
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had an acute intracerebral hemorrhage within the past 10 days causing hemiparesis or hemiplegia
- Fugl-Meyer motor scale (FMMS) scores of 55 or less
- Written informed consent for participation in the trial
Who cannot join
- Severe post-stroke disability (National Institutes of Health stroke scale [NIHSS] score >20)
- Premorbid disability, evidenced by residual motor deficit from a previous stroke
- Comprehension deficit or severe aphasia
- Previous diagnosis of depression or one of the following:
- Hospital Anxiety and Depression Scale score ≥11 points
- Taking antidepressant drugs two weeks before inclusion
- Taking neuroleptic drugs or benzodiazepines two weeks before inclusion
- Other major diseases with life expectancy less than 3 months.
Trial locations and contacts
4 sites in 1 country.
Mexico4 sites
Hospital General de Zona #1
Aguascalientes, Aguascalientes, 202301
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
Instituto Nacional de Neurología y Neurocirugía
Mexico City, Mexico City, 14269
Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus
Villahermosa, Tabasco, 86126
About this study
Official title: Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage (FMRICH): a Randomised Placebo-controlled Trial
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will be carried out in Mexico. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral hemorrhage.
Read the detailed description
Spontaneous, nontraumatic intracerebral hemorrhage (ICH) is a subtype of stroke that causes a great amount of disability, economic and social burden. This is particularly true in developing countries where it accounts for between 20% and 50% of all strokes. Pharmacological and surgical interventions have been attempted to diminish the mortality and disability derived from ICH, with unsuccessful results. Recently the use of Fluoxetine in addition to physical rehabilitation has been proven useful to improve motor recovery from cerebral infarct. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral hemorrhage.
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial. This trial will recruit 86 patients with intracerebral hemorrhage of both sexes, ages >18 years, from four Mexican hospitals. The patients will receive either 20mg of fluoxetine or a placebo once daily for 90 days. The primary outcome is the mean change in Fugl-Meyer Motor Scale score between inclusion (day 0) and day 90. The secondary outcomes will be changes in Barthel Index, Modified Rankin scale and National Institutes of Health (NIH) Stroke Scale. The outcomes will be measured at day 45±7days and at day 90, for a total of four visits with each subject (at screening and at 0, 45 and 90days).
- Conditions
- Intracerebral Hemorrhage, Motor Impairment
- Being tested
- Fluoxetine, Placebo
- Keywords
- Cerebrovascular Disorders, Cardiovascular Diseases, Intracerebral Hemorrhage, Serotonin Uptake Inhibitors, Therapeutic Uses
- Medical subject headings
- Cerebral Hemorrhage, Cerebrovascular Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called Fluoxac
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Experimental | fluoxetine per os 20 mg daily Receives: Drug: Fluoxetine |
| Placebo | Placebo comparator | per os daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Motor Scale score
Change from Baseline in Fugl Meyer Motor Scale score at 90 days
Measured: Baseline and 90 days
Secondary outcomes (3)
Barthel Index
Change from Baseline in Barthel Index at 90 days
Measured: Baseline and 90 days
modified Rankin Scale
Change from Baseline in modified Rankin Scale at 90 days
Measured: Baseline and 90 days
NIH Stroke Scale
Change from Baseline in NIH Stroke Scale at 90 days
Measured: Baseline and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Study recruitment was suspended due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Aguascalientes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Manuel Marquez-Romero, Universidad Autónoma de Aguascalientes
- Investigators
- Juan M Marquez-Romero, MD, Principal investigator, Universidad Autónoma de AguascalientesAngel A Arauz, PhD, Study director, Instituto Nacional de Neurología y Neurocirugía
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737541
- Sponsor's protocol ID
- 83/11
- Acronym
- FMRICH
- Status last verified
- Aug 2014
- First submitted
- 21 Nov 2012
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marquez-Romero JM, Arauz A, Ruiz-Sandoval JL, Cruz-Estrada Ede L, Huerta-Franco MR, Aguayo-Leytte G, Ruiz-Franco A, Silos H. Fluoxetine for motor recovery after acute intracerebral hemorrhage (FMRICH): study protocol for a randomized, double-blind, placebo-controlled, multicenter trial. Trials. 2013 Mar 19;14:77. doi: 10.1186/1745-6215-14-77.
PubMed 23510124Marquez-Romero JM, Reyes-Martinez M, Huerta-Franco MR, Ruiz-Franco A, Silos H, Arauz A. Fluoxetine for motor recovery after acute intracerebral hemorrhage, the FMRICH trial. Clin Neurol Neurosurg. 2020 Mar;190:105656. doi: 10.1016/j.clineuro.2019.105656. Epub 2019 Dec 28.
PubMed 31896491
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage (FMRICH): a Randomised Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01737541
- Acronym / sponsor ID
- FMRICH / 83/11
- Conditions
- Intracerebral Hemorrhage, Motor Impairment
- Keywords
- Cerebrovascular Disorders, Cardiovascular Diseases, Intracerebral Hemorrhage, Serotonin Uptake Inhibitors, Therapeutic Uses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study recruitment was suspended due to lack of funding
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad Autónoma de AguascalientesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Nov 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 is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will be carried out in Mexico. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral hemorrhage.
Detailed description
Spontaneous, nontraumatic intracerebral hemorrhage (ICH) is a subtype of stroke that causes a great amount of disability, economic and social burden. This is particularly true in developing countries where it accounts for between 20% and 50% of all strokes. Pharmacological and surgical interventions have been attempted to diminish the mortality and disability derived from ICH, with unsuccessful results. Recently the use of Fluoxetine in addition to physical rehabilitation has been proven useful to improve motor recovery from cerebral infarct. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral hemorrhage.
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial. This trial will recruit 86 patients with intracerebral hemorrhage of both sexes, ages >18 years, from four Mexican hospitals. The patients will receive either 20mg of fluoxetine or a placebo once daily for 90 days. The primary outcome is the mean change in Fugl-Meyer Motor Scale score between inclusion (day 0) and day 90. The secondary outcomes will be changes in Barthel Index, Modified Rankin scale and National Institutes of Health (NIH) Stroke Scale. The outcomes will be measured at day 45±7days and at day 90, for a total of four visits with each subject (at screening and at 0, 45 and 90days).
Study design
- Primary purpose
- Supportive care
- 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: Fluoxetinefluoxetine per os 20 mg daily |
| Placebo | Placebo comparator | Drug: Placeboper os daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who had an acute intracerebral hemorrhage within the past 10 days causing hemiparesis or hemiplegia
- Fugl-Meyer motor scale (FMMS) scores of 55 or less
- Written informed consent for participation in the trial
Key exclusion criteria (8 listed)
- Severe post-stroke disability (National Institutes of Health stroke scale [NIHSS] score >20)
- Premorbid disability, evidenced by residual motor deficit from a previous stroke
- Comprehension deficit or severe aphasia
- Previous diagnosis of depression or one of the following:
- Taking neuroleptic drugs or benzodiazepines two weeks before inclusion
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: Fluoxac | Drug | Fluoxetine |
| Placebo | Drug | Placebo |
Primary outcome
Fugl Meyer Motor Scale score
Time frame: Baseline and 90 days
Change from Baseline in Fugl Meyer Motor Scale score at 90 days
3 secondary outcomes
Barthel Index
Time frame: Baseline and 90 days
modified Rankin Scale
Time frame: Baseline and 90 days
NIH Stroke Scale
Time frame: Baseline and 90 days
Results and safety
The study was stopped early (reason given: Study recruitment was suspended due to lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
- Background: PubMed 23510124Marquez-Romero JM, Arauz A, Ruiz-Sandoval JL, Cruz-Estrada Ede L, Huerta-Franco MR, Aguayo-Leytte G, Ruiz-Franco A, Silos H. Fluoxetine for motor recovery after acute intracerebral hemorrhage (FMRICH): study protocol for a randomized, double-blind, placebo-controlled, multicenter trial. Trials. 2013 Mar 19;14:77. doi: 10.1186/1745-6215-14-77.
- Derived from this study: PubMed 31896491Marquez-Romero JM, Reyes-Martinez M, Huerta-Franco MR, Ruiz-Franco A, Silos H, Arauz A. Fluoxetine for motor recovery after acute intracerebral hemorrhage, the FMRICH trial. Clin Neurol Neurosurg. 2020 Mar;190:105656. doi: 10.1016/j.clineuro.2019.105656. Epub 2019 Dec 28.
- Full text protocolLink provided by the sponsor.
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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.
Juan M Marquez-Romero, MD principal investigator
Universidad Autónoma de Aguascalientes
Angel A Arauz, PhD study director
Instituto Nacional de Neurología y Neurocirugía
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoxetine in people with Intracerebral Hemorrhage and Motor Impairment, run by Universidad Autónoma de Aguascalientes at 4 sites in Mexico.
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 3 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: stopped early, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Mexico. 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 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 was stopped early (reason given: Study recruitment was suspended due to lack of funding). Results are not available in the source record.
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 score (time frame: Baseline and 90 days). 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 NCT01737541, which also lists 2 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 22 Aug 2014.