Promoting Recovery After STroke With Amantadine

Who is this study for? Patients with ischemic or hemorrhagic stroke
What treatments are being studied? Amantadine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

• Able to participate in administered tests

Locations
United States
Pennsylvania
The Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Aaron Rothstein, M.D
aaron.rothstein@pennmedicine.upenn.edu
267-624-4442
Backup
Nichole Gallatti, M.S.Ed.
nichole.gallatti@pennmedicine.upenn.edu
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 60
Treatments
Placebo_comparator: Placebo
placebo pill, twice daily
Active_comparator: Amantadine
100 mg amantadine twice daily, or if 65 years or older once daily
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov

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