Acute StrokePhase 2MAMBONCT03728153
Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania
A Phase 2 study testing Fluoxetine 20 MG Oral Tablet in people with Acute Stroke and Stroke, Ischemic, run by Massachusetts General Hospital at 1 site in Tanzania.
Trial summary
This is a phase II, randomized study of 120 adults age 18 or above who will prescribed 20mg daily Fluoxetine for 90 days following acute, ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Stroke, Stroke, Ischemic
- What is being tested?
- Fluoxetine 20 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTanzania
- Study dates
- 26 Nov 2019to 6 Jan 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is 18 years of age or older
- Participant has experienced a CT-confirmed ischemic stroke w/in 21 days of enrollment
Who cannot join
- NIH Stroke Scale Score >20 points
- Unconscious at presentation
- Hemorrhagic conversion of ischemic infarct
- transient ischemic symptoms <24h,
- Current antidepressant or psychoactive drug use (e.g. SSRI, monoxidase amine inhibitor, benzodiazepine).
- Current pregnancy.
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- History of recent head trauma.
- Baseline motor deficits from other etiologies including prior stroke.
- Dysphagia preventing the swallowing of a pill.
- Hyponatremia (<125 mmol/L), hepatic impairment as defined by a serum alanine aminotransferase (ALT) of >120 U/L.
- Renal impairment as defined by a creatinine >180 micromol/L or GFR <30mL/min/1.73m2.
- Patients who are moribund for other reasons and unlikely to survive to 90 days will also be excluded from participation.
- Contraindication to MRI (e.g. piercings/tattoos, electronic/metallic implants, claustrophobia)
- Contraindication to lumbar puncture (e.g. infection at site of needle insertion, evidence of elevated ICP, coagulopathy/thrombocytopenia or use of therapeutic anticoagulation, or a history of LP complications).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MAMBO: Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania
This is a phase II, randomized study of 120 adults age 18 or above who will prescribed 20mg daily Fluoxetine for 90 days following acute, ischemic stroke.
Read the detailed description
This is a prospective, phase II study of fluoxetine for motor recovery post-stroke in adults with new-onset ischemic stroke in urban Tanzania. Participants will be enrolled at the Muhimbili National Hospital (MNH) in Dar Es Salaam after confirmation of exclusion and inclusion criteria, including a head CT. Participants will be enrolled within 21 days of acute, ischemic stroke. The study will utilize a novel method for monitoring patient medication adherence: electronic pill bottles that can record medication use events. The primary goals of this study are to assess the safety and tolerability of fluoxetine post-stroke to evaluate the feasibility of conducting a larger, phase III study in the future.
Vital status will be monitored throughout the study's enrollment period. At enrollment, participants will have cognitive tests administered, receive lumbar puncture, and receive an MRI brain. After discharge from the hospital, participants will be seen at 30-, 60-, and 90-days post-enrollment for an in-person study visit. At each time point, investigators will draw 10-15 mL of blood; download medication adherence data from participants' electronic pill bottles; and inquire about adverse events and evaluate patient disability through the modified Rankin Scale. If participants stop taking their daily pill, stroke specific reasons for non-adherence will be inquired including dysphagia, self-administration, and other concerns.
Primary assessments will be for safety and tolerability, as well as measurement of the Fugl-Meyer Motor Scale. Medication use data will also be collected through the electronic pill bottle, which will be returned to study investigators. As secondary assessments, the PHQ-9, and the Asberg Depressive Symptom Questionnaire will be administered. All 90-day assessments will be administered by senior site investigators, who will take a final 10-15mL blood draw to test for serum sodium and liver enzymes, possible adverse events related to long-term fluoxetine use, conduct a second MRI brain, evaluate participant mRS, and inquire about tolerability issues. Completion of the 90-day visit and associated assessments is considered the study endpoint.
- Conditions
- Acute Stroke, Stroke, Ischemic
- Being tested
- Fluoxetine 20 MG Oral Tablet
- Keywords
- Motor recovery
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoxetine 20 MG Oral TabletDrug
Also called Prozac 20 MG Oral Tablet
Once-daily dosing for 90 days
| Study group | Role | What they receive |
|---|---|---|
| 20mg dose | Experimental | Fluoxetine 20 MG Oral Tablet Receives: Drug: Fluoxetine 20 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Sodium Concentration
Serum Sodium Concentration was measured in mmol/L. Hyponatremia was considered as <125 mmol/L.
Measured: 90 days following acute, ischemic stroke
Serum Alanine Aminotransferase (ALT)
Hepatic impairment was measured by elevation of hepatic enzyme (serum alanine aminotransferase; ALT) of >120 U/L
Measured: 90 days
Secondary outcomes (4)
Fugl-Meyer Motor Scale Score for Assessment of Motor Function After Stroke
The Fugl Meyer motor scale is used to assess post-stroke motor recovery in stroke patients. It is scored on a scale from 0 to 100, with lower scores indicating greater disability. It evaluates both lower and upper extremities for motor performance: 66 points are allocated to the upper extremities, 34 to the lower extremities. The two extremities are summed to achieve the total score.
Measured: 90 days following acute, ischemic stroke
Montgomery-Asberg Depression Rating Scale
10-item questionnaire used to evaluate the severity of a patient's depressive symptoms. Each item is scored on a scale from 0 to 6, the scores are summed, and the total score (0 to 60 points) is reported. The greater the score, the more severe the degree of depression.
Measured: 90 days following acute, ischemic stroke
Modified Rankin Scale
Validated instrument for measuring the degree of disability in stroke patients. The modified Rankin Scale is based on a physicians subjective evaluation. The scale ranges from 0, indicating perfect health, to 6, indicating that the patient is dead.
Measured: 90 days following acute, ischemic stroke
The Patient Health Questionnaire-9 (PHQ-9) Scale for Measuring Depression
The PHQ-9 is a validated 9-point questionnaire for measuring depression symptom severity. Each question is scored from 0-3. Answers are summed and the total score (0 to 27) is reported. The greater the score, the greater the severity of depression.
Measured: 90 days following acute ischemic stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start26 Nov 2019
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Phase II study of one dose
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Responsible party
- Principal investigator, Farrah Mateen, Massachusetts General Hospital
- Investigators
- Farrah J Mateen, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728153
- Sponsor's protocol ID
- 2018P001693
- Acronym
- MAMBO
- Status last verified
- May 2022
- First submitted
- 29 Oct 2018
- Last updated
- 25 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Contingent upon the requirements of the Tanzanian National Medical Institute for Research
Publications
Vogel AC, Okeng'o K, Chiwanga F, Ismail SS, Buma D, Pothier L, Mateen FJ. MAMBO: Measuring ambulation, motor, and behavioral outcomes with post-stroke fluoxetine in Tanzania: Protocol of a phase II clinical trial. J Neurol Sci. 2020 Jan 15;408:116563. doi: 10.1016/j.jns.2019.116563. Epub 2019 Nov 6.
PubMed 31731111
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAMBO: Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania
- ClinicalTrials.gov ID
- NCT03728153
- Acronym / sponsor ID
- MAMBO / 2018P001693
- Conditions
- Acute Stroke, Stroke, Ischemic
- Keywords
- Motor recovery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Posted 25 May 2022
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 phase II, randomized study of 120 adults age 18 or above who will prescribed 20mg daily Fluoxetine for 90 days following acute, ischemic stroke.
Detailed description
This is a prospective, phase II study of fluoxetine for motor recovery post-stroke in adults with new-onset ischemic stroke in urban Tanzania. Participants will be enrolled at the Muhimbili National Hospital (MNH) in Dar Es Salaam after confirmation of exclusion and inclusion criteria, including a head CT. Participants will be enrolled within 21 days of acute, ischemic stroke. The study will utilize a novel method for monitoring patient medication adherence: electronic pill bottles that can record medication use events. The primary goals of this study are to assess the safety and tolerability of fluoxetine post-stroke to evaluate the feasibility of conducting a larger, phase III study in the future.
Vital status will be monitored throughout the study's enrollment period. At enrollment, participants will have cognitive tests administered, receive lumbar puncture, and receive an MRI brain. After discharge from the hospital, participants will be seen at 30-, 60-, and 90-days post-enrollment for an in-person study visit. At each time point, investigators will draw 10-15 mL of blood; download medication adherence data from participants' electronic pill bottles; and inquire about adverse events and evaluate patient disability through the modified Rankin Scale. If participants stop taking their daily pill, stroke specific reasons for non-adherence will be inquired including dysphagia, self-administration, and other concerns.
Primary assessments will be for safety and tolerability, as well as measurement of the Fugl-Meyer Motor Scale. Medication use data will also be collected through the electronic pill bottle, which will be returned to study investigators. As secondary assessments, the PHQ-9, and the Asberg Depressive Symptom Questionnaire will be administered. All 90-day assessments will be administered by senior site investigators, who will take a final 10-15mL blood draw to test for serum sodium and liver enzymes, possible adverse events related to long-term fluoxetine use, conduct a second MRI brain, evaluate participant mRS, and inquire about tolerability issues. Completion of the 90-day visit and associated assessments is considered the study endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase II study of one dose
| Arm | Type | Receives |
|---|---|---|
| 20mg dose | Experimental | Drug: Fluoxetine 20 MG Oral TabletFluoxetine 20 MG Oral Tablet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant is 18 years of age or older
- Participant has experienced a CT-confirmed ischemic stroke w/in 21 days of enrollment
Key exclusion criteria (14 listed)
- NIH Stroke Scale Score >20 points
- Unconscious at presentation
- Hemorrhagic conversion of ischemic infarct
- transient ischemic symptoms <24h,
- Current antidepressant or psychoactive drug use (e.g. SSRI, monoxidase amine inhibitor, benzodiazepine).
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 |
|---|---|---|
| Fluoxetine 20 MG Oral TabletAlso: Prozac 20 MG Oral TabletOnce-daily dosing for 90 days | Drug | 20mg dose |
Primary outcome
Serum Sodium Concentration
Time frame: 90 days following acute, ischemic stroke
Serum Sodium Concentration was measured in mmol/L. Hyponatremia was considered as <125 mmol/L.
Serum Alanine Aminotransferase (ALT)
Time frame: 90 days
Hepatic impairment was measured by elevation of hepatic enzyme (serum alanine aminotransferase; ALT) of >120 U/L
4 secondary outcomes
Fugl-Meyer Motor Scale Score for Assessment of Motor Function After Stroke
Time frame: 90 days following acute, ischemic stroke
Montgomery-Asberg Depression Rating Scale
Time frame: 90 days following acute, ischemic stroke
Modified Rankin Scale
Time frame: 90 days following acute, ischemic stroke
The Patient Health Questionnaire-9 (PHQ-9) Scale for Measuring Depression
Time frame: 90 days following acute ischemic stroke
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31731111Vogel AC, Okeng'o K, Chiwanga F, Ismail SS, Buma D, Pothier L, Mateen FJ. MAMBO: Measuring ambulation, motor, and behavioral outcomes with post-stroke fluoxetine in Tanzania: Protocol of a phase II clinical trial. J Neurol Sci. 2020 Jan 15;408:116563. doi: 10.1016/j.jns.2019.116563. Epub 2019 Nov 6.
- Individual participant dataSharing planned: No. Contingent upon the requirements of the Tanzanian National Medical Institute for Research
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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.
Farrah J Mateen, MD, PhD principal investigator
Massachusetts General Hospital
1 site 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 20 MG Oral Tablet in people with Acute Stroke and Stroke, Ischemic, run by Massachusetts General Hospital at 1 site in Tanzania.
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 14 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 25 May 2022. 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 Tanzania. 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 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?
Yes. Results are posted in the registry (first posted 25 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Sodium Concentration (time frame: 90 days following acute, ischemic stroke). 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?
On the ClinicalTrials.gov record for NCT03728153, which also lists 1 linked publication.
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 25 May 2022.