Promoting Recovery After STroke With Amantadine
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- University of Pennsylvania
- Study ID
- NCT05140148
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Stroke Hemorrhagic
- Stroke, Ischemic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Amantadine — DRUGAmantadine is a antiviral drug and dopamine promoter that is currently approved by the FDA for the treatment of influenza A and Parkinson's Disease
- Placebo — DRUGplacebo pills
Study Details
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.
Key Dates
- Start date
- Feb 1, 2022
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2027
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Placeboplacebo pill, twice daily
- Active Comparator: Amantadine100 mg amantadine twice daily, or if 65 years or older once daily
Primary Outcome Measure
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Day 90 ]
Central Contacts
- Aaron Rothstein, M.D267-624-4442
- Nichole Gallatti, M.S.Ed.
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Nichole Gallatti Scott Kasner, MD (PRINCIPAL_INVESTIGATOR) |
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