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Promoting Recovery After STroke With Amantadine (PRESTA)

Primary Purpose

Stroke, Ischemic, Stroke Hemorrhagic

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amantadine
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) -

Sites / Locations

  • The Hospital of the University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Amantadine

Arm Description

placebo pill, twice daily

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Global rating on the Stroke Impact Scale (SIS)
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
Total score on the National Institute of Health Stroke Scale (NIHSS)
Assessment for stroke deficits in patients; scores range from 0-42, with a higher score indicating more severe stroke symptoms
Digit Symbol Substitution Test (DSST) score
Cognitive test; scores range from 0 to 100, with higher scores indicating higher cognitive function
Montreal Cognitive Assessment test (MOCA) score
Cognitive test; scores range from 0 to 30, with higher scores indicating higher cognitive function
Patient Health Questionnaire (PHQ-9) score
Patient reported survey of depression symptoms; scores range from 0 to 27, with higher scores indicating higher levels of depression
Upper limb strength
The upper limb strength for each subject with be measured using a hand dynamometer
Modified Rankin Score (mRS)
Assessment of post-stroke recovery; scores range from 0 to 6, with higher scores indicating more severe impairments on daily functioning

Full Information

First Posted
September 15, 2021
Last Updated
February 15, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05140148
Brief Title
Promoting Recovery After STroke With Amantadine
Acronym
PRESTA
Official Title
Promoting Recovery After STroke With Amantadine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Stroke Hemorrhagic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo pill, twice daily
Arm Title
Amantadine
Arm Type
Active Comparator
Arm Description
100 mg amantadine twice daily, or if 65 years or older once daily
Intervention Type
Drug
Intervention Name(s)
Amantadine
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
placebo pills
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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
Day 90
Secondary Outcome Measure Information:
Title
Global rating on the Stroke Impact Scale (SIS)
Description
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
Title
Total score on the National Institute of Health Stroke Scale (NIHSS)
Description
Assessment for stroke deficits in patients; scores range from 0-42, with a higher score indicating more severe stroke symptoms
Time Frame
90 days
Title
Digit Symbol Substitution Test (DSST) score
Description
Cognitive test; scores range from 0 to 100, with higher scores indicating higher cognitive function
Time Frame
90 Days
Title
Montreal Cognitive Assessment test (MOCA) score
Description
Cognitive test; scores range from 0 to 30, with higher scores indicating higher cognitive function
Time Frame
90 Days
Title
Patient Health Questionnaire (PHQ-9) score
Description
Patient reported survey of depression symptoms; scores range from 0 to 27, with higher scores indicating higher levels of depression
Time Frame
90 days
Title
Upper limb strength
Description
The upper limb strength for each subject with be measured using a hand dynamometer
Time Frame
90 Days
Title
Modified Rankin Score (mRS)
Description
Assessment of post-stroke recovery; scores range from 0 to 6, with higher scores indicating more severe impairments on daily functioning
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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) 24 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 Exclusion Criteria: 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 Parkinson's disease Amantadine allergy Elevated liver function tests (aspartate aminotransferase and alanine aminotransferase above the upper limit of normal) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Rothstein, M.D
Phone
267-624-4442
Email
aaron.rothstein@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nichole Gallatti, M.S.Ed.
Email
nichole.gallatti@pennmedicine.upenn.edu
Facility Information:
Facility Name
The Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nichole Gallatti
Email
nichole.gallatti@penn.medicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Scott Kasner, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Promoting Recovery After STroke With Amantadine

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