Trial Outcomes & Findings for Maraviroc to Augment Rehabilitation Outcomes After Stroke (NCT NCT03172026)

Results Overview

Timed walking speed over 10 meters. The evaluable sample size of 30 in each group will have 80% power to detect a difference in means of -0.206 (m/s), the difference between an assumed usual care walking speed of 0.51 (SD=0.28) and an assumed intervention group mean walking speed of 0.716. This assumes a common standard deviation in the two groups and a two group t-test with a 0.05 two-sided significance level. The estimates for the mean and standard deviation for walking speed come from the LEAPS RCT (Duncan, N Engl J Med, 2011). The t-test used for the power calculation is a simplification of the mixed effects analysis plan for the primary endpoints.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

2 participants

Primary outcome timeframe

Baseline, 6 months post

Results posted on

2021-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	Maraviroc + Augmented Rehabilitation Maraviroc 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.	Placebo + Augmented Rehabilitation Placebo 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.
Overall Study STARTED	2	0
Overall Study 8 Week Assessment	0	0
Overall Study 6 Month Assessment	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Maraviroc + Augmented Rehabilitation Maraviroc 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.	Placebo + Augmented Rehabilitation Placebo 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.
Overall Study Withdrawal by Subject	1	0
Overall Study COVID restrictions	1	0

Baseline Characteristics

Maraviroc to Augment Rehabilitation Outcomes After Stroke

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline, 6 months post

Population: Participants exited study prior to 6 month assessment

Timed walking speed over 10 meters. The evaluable sample size of 30 in each group will have 80% power to detect a difference in means of -0.206 (m/s), the difference between an assumed usual care walking speed of 0.51 (SD=0.28) and an assumed intervention group mean walking speed of 0.716. This assumes a common standard deviation in the two groups and a two group t-test with a 0.05 two-sided significance level. The estimates for the mean and standard deviation for walking speed come from the LEAPS RCT (Duncan, N Engl J Med, 2011). The t-test used for the power calculation is a simplification of the mixed effects analysis plan for the primary endpoints.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 6 months post

Population: Participants exited study prior to 6 month assessment

Assessment of upper extremity function. Our sample size of 30 for each group is based on a statistical power of 80% with an alpha of 5% for detecting a meaningful difference of 6 points, i.e., a 10% change, which has been suggested by several completed trials. In a stroke trial, the standard deviation was 8 points measured at 2 weeks post stroke.