Promoting Recovery After STroke With Amantadine

NCT05140148 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 849451
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Tolerability of the study drug will be assessed based on the proportion of patients who adherent with at least 80% of study medication.

  Day 90

Secondary Outcomes (7)

• Global rating on the Stroke Impact Scale (SIS)

  90 days

• Total score on the National Institute of Health Stroke Scale (NIHSS)

  90 days

• Digit Symbol Substitution Test (DSST) score

  90 Days

• Montreal Cognitive Assessment test (MOCA) score

  90 Days

• Patient Health Questionnaire (PHQ-9) score

  90 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo pill, twice daily

Drug: Placebo

Amantadine

ACTIVE COMPARATOR

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

Drug: Amantadine

Interventions

Amantadine 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

Amantadine

Placebo DRUG

placebo pills

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• Diagnosis of dementia or mild cognitive impairment prior to index stroke
• Prior limb amputation
• Currently prescribed or taking a primary anticholinergic medication
• Currently enrolled in any other investigational pharmacologic or procedural clinical trial
• Malignancy with active treatment
• History of prior stroke with residual impairment
• Current or prior neuroleptic use
• 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)
• Prior history of seizures
• Prior treatment with amantadine

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Aaron Rothstein, M.D

CONTACT

267-624-4442; aaron.rothstein@pennmedicine.upenn.edu

Nichole Gallatti, M.S.Ed.

CONTACT

nichole.gallatti@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: December 1, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)