CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Fluoxetine Hydrochloride +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03448159
NCT03448159Phase 2Completed
CompareCT.gov

FLOW Trial: Fluoxetine to Open the Critical Period Time Window to Improve Motor Recovery After Stroke

University Health Network, Toronto·interventional·Posted Feb 27, 2018·Updated Nov 4, 2022

In Brief

A Phase 2 clinical trial evaluating Fluoxetine Hydrochloride, Placebo, and 1 other intervention for Stroke and 9 related conditions. Completed, enrolled 52 participants across 8 sites.

Detailed Summary

The FLOW trial is a randomized placebo-controlled trial analyzing the effect of coupling an anti-depressant, fluoxetine (Prozac), and exercise to improve motor recovery following a stroke.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Cerebrovascular Accident, Cerebral Infarction, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases
CountriesCanada
CollaboratorsUniversity of British Columbia, Sunnybrook Health Sciences Centre, University of Calgary, Dalhousie University, Parkwood Hospital, London, Ontario, Riverview Health Centre Foundation, Memorial University of Newfoundland, Applied Health Research Centre, Brain Canada, Heart and Stroke Foundation of Canada

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 27, 2018
Enrollment StartJan 1, 2019
Primary CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.3 years ago

Interventions

Fluoxetine Hydrochloridedrug

Half of the participants will take fluoxetine for a period of 15-17 weeks (depending on ramp-up period).

Placeboother

Half of the participants will take the a placebo for a period of 15-17 weeks (depending on ramp-up period).

Exercise Programbehavioral

All participants will take part in a 12-week exercise program. The program will run 3 times/week, 1 hour/class.