- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03728153
Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania (MAMBO)
MAMBO: Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Dar es Salaam, Tanzania
- Muhimbili National Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Participant is 18 years of age or older
- Participant has experienced a CT-confirmed ischemic stroke w/in 21 days of enrollment
Exclusion Criteria:
- 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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 20mg dose
Fluoxetine 20 MG Oral Tablet
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Once-daily dosing for 90 days
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Serum Sodium Concentration
Lasso di tempo: 90 days following acute, ischemic stroke
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Serum Sodium Concentration was measured in mmol/L.
Hyponatremia was considered as <125 mmol/L.
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90 days following acute, ischemic stroke
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Serum Alanine Aminotransferase (ALT)
Lasso di tempo: 90 days
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Hepatic impairment was measured by elevation of hepatic enzyme (serum alanine aminotransferase; ALT) of >120 U/L
|
90 days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Fugl-Meyer Motor Scale Score for Assessment of Motor Function After Stroke
Lasso di tempo: 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.
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90 days following acute, ischemic stroke
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Montgomery-Asberg Depression Rating Scale
Lasso di tempo: 90 days following acute, ischemic stroke
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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.
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90 days following acute, ischemic stroke
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Modified Rankin Scale
Lasso di tempo: 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.
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90 days following acute, ischemic stroke
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The Patient Health Questionnaire-9 (PHQ-9) Scale for Measuring Depression
Lasso di tempo: 90 days following acute ischemic stroke
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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.
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90 days following acute ischemic stroke
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Farrah J Mateen, MD, PhD, Massachusetts General Hospital
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Ictus
- Ictus ischemico
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Psicofarmaci
- Inibitori dell'assorbimento della serotonina
- Inibitori dell'assorbimento dei neurotrasmettitori
- Modulatori di trasporto a membrana
- Agenti serotoninergici
- Agenti antidepressivi
- Inibitori dell'enzima del citocromo P-450
- Agenti antidepressivi, seconda generazione
- Inibitori del citocromo P-450 CYP2D6
- Fluoxetina
Altri numeri di identificazione dello studio
- 2018P001693
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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