PRESTA: Promoting Recovery After STroke With Amantadine

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT05140148
Collaborator
(none)
60
1
2
28.9
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Promoting Recovery After STroke With Amantadine
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

placebo pill, twice daily

Drug: Placebo
placebo pills

Active Comparator: Amantadine

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

Drug: 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Global rating on the Stroke Impact Scale (SIS) [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

  2. Total score on the National Institute of Health Stroke Scale (NIHSS) [90 days]

    Assessment for stroke deficits in patients; scores range from 0-42, with a higher score indicating more severe stroke symptoms

  3. Digit Symbol Substitution Test (DSST) score [90 Days]

    Cognitive test; scores range from 0 to 100, with higher scores indicating higher cognitive function

  4. Montreal Cognitive Assessment test (MOCA) score [90 Days]

    Cognitive test; scores range from 0 to 30, with higher scores indicating higher cognitive function

  5. Patient Health Questionnaire (PHQ-9) score [90 days]

    Patient reported survey of depression symptoms; scores range from 0 to 27, with higher scores indicating higher levels of depression

  6. Upper limb strength [90 Days]

    The upper limb strength for each subject with be measured using a hand dynamometer

  7. Modified Rankin Score (mRS) [90 days]

    Assessment of post-stroke recovery; scores range from 0 to 6, with higher scores indicating more severe impairments on daily functioning

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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) -

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Scott Kasner, MD, Professor of Neurology, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05140148
Other Study ID Numbers:
  • 849451
First Posted:
Dec 1, 2021
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022