Promoting Recovery After STroke With Amantadine (NCT05140148) | Clinical Trial Compass
RecruitingPhase 2
Promoting Recovery After STroke With Amantadine
United States60 participantsStarted 2022-02-01
Plain-language summary
The investigators aim to examine whether amantadine can help patients recover from stroke. This will be a blinded randomized clinical trial (RCT). Patients will be randomized post-ischemic or hemorrhagic stroke either to the placebo arm or amantadine arm. Patients will be on study drug or placebo for 1 month but will be enrolled for 3 months total. At various time points patients will be examined and fill out questionnaires to determine level of stroke recovery.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 18 to 85 years old, male and female
✓. Modified Rankin Score (mRS)\<=2 prior to stroke
✓. Ischemic or hemorrhagic stroke as diagnosed by vascular neurologist or as proven on magnetic resonance imaging (MRI) or non-contrast head computed tomography NCHCT)
✓. 24 hours to 3 weeks after stroke onset or time last known well prior to detection of symptoms
✓. National Institute of Health Stroke Scale (NIHSS)\>=3 and NIHSS\<=15
✓. Creatinine Clearance of greater than or equal to 60 mL/min using the Cockroft- Gault equation.
✓. Have passed a swallow evaluation prior to drug administration
✓. The patient is an acute rehabilitation candidate or candidate for the Homeward Stroke Program
Exclusion criteria
✕. Any degree of receptive aphasia
✕. Moderate or severe expressive aphasia
✕. Currently pregnant or plans to get pregnant
✕. Currently breastfeeding
✕. Any patient admitted with primary SubarachnoidH emorrhage (SAH )on either non-contrast head CT or MRI brain
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]