Promoting Recovery After STroke With Amantadine

NCT ID: NCT05140148

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2026-06-30

Brief 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.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

placebo pill, twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo pills

Amantadine

100 mg amantadine twice daily, or if 65 years or older once daily

Group Type: ACTIVE_COMPARATOR

Amantadine

Intervention Type: DRUG

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

Interventions

Amantadine

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

Intervention Type: DRUG

Placebo

placebo pills

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 18 to 85 years old, male and female

2. Modified Rankin Score (mRS)<=2 prior to stroke

3. Ischemic or hemorrhagic stroke as diagnosed by vascular neurologist or as proven on magnetic resonance imaging (MRI) or non-contrast head computed tomography NCHCT)

4. 24 hours to 3 weeks after stroke onset or time last known well prior to detection of symptoms

5. National Institute of Health Stroke Scale (NIHSS)>=3 and NIHSS<=15

6. Creatinine Clearance of greater than or equal to 60 mL/min using the Cockroft- Gault equation.

7. Have passed a swallow evaluation prior to drug administration

8. The patient is an acute rehabilitation candidate or candidate for the Homeward Stroke Program

9. Able to participate in administered tests

Exclusion Criteria

1. Any degree of receptive aphasia

2. Moderate or severe expressive aphasia

3. Currently pregnant or plans to get pregnant

4. Currently breastfeeding

5. Any patient admitted with primary SubarachnoidH emorrhage (SAH )on either non-contrast head CT or MRI brain

6. Diagnosis of dementia or mild cognitive impairment prior to index stroke

7. Prior limb amputation

8. Currently prescribed or taking a primary anticholinergic medication

9. Currently enrolled in any other investigational pharmacologic or procedural clinical trial

10. Malignancy with active treatment

11. History of prior stroke with residual impairment

12. Current or prior neuroleptic use

13. History of suicidality or psychosis (The Columbia Suicide Severity Ratings Scale (C-SSRS) will be administered at the screening visit to assess depression and suicidal thoughts for subject eligibility. Any subjects who indicate severe depression or suicidal thoughts and/or attempts within the last year will not be eligible)

14. Prior history of seizures

15. Prior treatment with amantadine

16. Parkinson's disease

17. Amantadine allergy

18. Elevated liver function tests (aspartate aminotransferase and alanine aminotransferase above the upper limit of normal) -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Scott Kasner, MD

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aaron Rothstein, M.D

Role: CONTACT

aaron.rothstein@pennmedicine.upenn.edu

267-624-4442

Nichole Gallatti, M.S.Ed.

Role: CONTACT

nichole.gallatti@pennmedicine.upenn.edu

Facility Contacts

Nichole Gallatti

Role: primary

nichole.gallatti@penn.medicine.upenn.edu

Other Identifiers

849451

Identifier Type: -

Identifier Source: org_study_id