The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT05140148
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 2
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Amantadine 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 pills
Time frame: Day 90
Tolerability of the study drug will be assessed based on the proportion of patients who adherent with at least 80% of study medication.
Time frame: 90 days
Patient reported measure of stroke recovery; Stroke Impact Scale has 59 items in 8 domains (each domain score ranges from 0-100) And a 9th domain that is an overall scale from 0-100. Each item in the first 8 domains is on a likert scale from 1-5 where 5 is better and 1 is worse
Time frame: 90 days
Assessment for stroke deficits in patients; scores range from 0-42, with a higher score indicating more severe stroke symptoms
Time frame: 90 Days
Cognitive test; scores range from 0 to 100, with higher scores indicating higher cognitive function
Time frame: 90 Days
Cognitive test; scores range from 0 to 30, with higher scores indicating higher cognitive function
Time frame: 90 days
Patient reported survey of depression symptoms; scores range from 0 to 27, with higher scores indicating higher levels of depression
Time frame: 90 Days
The upper limb strength for each subject with be measured using a hand dynamometer
Time frame: 90 days
Assessment of post-stroke recovery; scores range from 0 to 6, with higher scores indicating more severe impairments on daily functioning
Contact information is provided by the study sponsor or research team.
Aaron Rothstein, M.D
CONTACT
Nichole Gallatti, M.S.Ed.
CONTACT
University of Pennsylvania
Other
Acronym: PRESTA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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