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

2. mai 2022 oppdatert av: Farrah Mateen, Massachusetts General Hospital

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

34

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tanzania
      • Dar es Salaam, Tanzania
        • Muhimbili National Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  1. NIH Stroke Scale Score >20 points
  2. Unconscious at presentation
  3. Hemorrhagic conversion of ischemic infarct
  4. transient ischemic symptoms <24h,
  5. Current antidepressant or psychoactive drug use (e.g. SSRI, monoxidase amine inhibitor, benzodiazepine).
  6. Current pregnancy.
  7. History of recent head trauma.
  8. Baseline motor deficits from other etiologies including prior stroke.
  9. Dysphagia preventing the swallowing of a pill.
  10. Hyponatremia (<125 mmol/L), hepatic impairment as defined by a serum alanine aminotransferase (ALT) of >120 U/L.
  11. Renal impairment as defined by a creatinine >180 micromol/L or GFR <30mL/min/1.73m2.
  12. Patients who are moribund for other reasons and unlikely to survive to 90 days will also be excluded from participation.
  13. Contraindication to MRI (e.g. piercings/tattoos, electronic/metallic implants, claustrophobia)
  14. 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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 20mg dose
Fluoxetine 20 MG Oral Tablet
Legemiddel: Fluoxetine 20 MG Oral Tablet
Once-daily dosing for 90 days
Andre navn:
  • Prozac 20 MG Oral Tablet

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serum Sodium Concentration
Tidsramme: 90 days following acute, ischemic stroke
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)
Tidsramme: 90 days
Hepatic impairment was measured by elevation of hepatic enzyme (serum alanine aminotransferase; ALT) of >120 U/L
90 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fugl-Meyer Motor Scale Score for Assessment of Motor Function After Stroke
Tidsramme: 90 days following acute, ischemic 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.
90 days following acute, ischemic stroke
Montgomery-Asberg Depression Rating Scale
Tidsramme: 90 days following acute, ischemic stroke
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.
90 days following acute, ischemic stroke
Modified Rankin Scale
Tidsramme: 90 days following acute, ischemic stroke
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.
90 days following acute, ischemic stroke
The Patient Health Questionnaire-9 (PHQ-9) Scale for Measuring Depression
Tidsramme: 90 days following acute ischemic stroke
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.
90 days following acute ischemic stroke

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Massachusetts General Hospital

Samarbeidspartnere

Muhimbili University of Health and Allied Sciences

Etterforskere

  • Hovedetterforsker: Farrah J Mateen, MD, PhD, Massachusetts General Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. november 2019

Primær fullføring (Faktiske)

6. januar 2021

Studiet fullført (Faktiske)

6. januar 2021

Datoer for studieregistrering

Først innsendt

29. oktober 2018

Først innsendt som oppfylte QC-kriteriene

30. oktober 2018

Først lagt ut (Faktiske)

1. november 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. mai 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. mai 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2018P001693

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Contingent upon the requirements of the Tanzanian National Medical Institute for Research

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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