Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania

NCT03728153 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2018P001693
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Stroke; Stroke, Ischemic

Keywords

Motor recovery

Outcome Measures

Primary Outcomes (2)

• Serum Sodium Concentration

  Serum Sodium Concentration was measured in mmol/L. Hyponatremia was considered as \<125 mmol/L.

  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

  90 days

Secondary Outcomes (4)

• Fugl-Meyer Motor Scale Score for Assessment of Motor Function After Stroke

  90 days following acute, ischemic stroke

• Montgomery-Asberg Depression Rating Scale

  90 days following acute, ischemic stroke

• Modified Rankin Scale

  90 days following acute, ischemic stroke

• The Patient Health Questionnaire-9 (PHQ-9) Scale for Measuring Depression

  90 days following acute ischemic stroke

Study Arms (1)

20mg dose

EXPERIMENTAL

Fluoxetine 20 MG Oral Tablet

Drug: Fluoxetine 20 MG Oral Tablet

Interventions

Fluoxetine 20 MG Oral Tablet DRUG

Once-daily dosing for 90 days

Also known as: Prozac 20 MG Oral Tablet

20mg dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is 18 years of age or older
• Participant has experienced a CT-confirmed ischemic stroke w/in 21 days of enrollment

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Muhimbili University of Health and Allied Sciences: collaborator

Study Sites (1)

Muhimbili National Hospital

Dar es Salaam, Tanzania

Location

Related Publications (1)

• 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.

  PMID: 31731111 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Fluoxetine; Tablets

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

Our study had several limitations. There was no placebo group. Three participants were later found to lack diffuse weighted imaging (DWI) changes on brain MRI when read by an off-site neuroradiologist. We are unable to report on whether fluoxetine in combination with other interventions would be valuable or is influenced by physical therapy. Depression was not measured at enrollment.

Results Point of Contact

• Title: Farrah Mateen
• Organization: Massachusetts General Hospital

fmateen@mgh.harvard.edu

16177248653

Study Officials

• Farrah J Mateen, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Phase II study of one dose

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 1, 2018
• Study Start: November 26, 2019
• Primary Completion: January 6, 2021
• Study Completion: January 6, 2021
• Last Updated: May 25, 2022
• Results First Posted: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)