Health TrialsbyHealthPanel

Promoting Recovery After STroke With Amantadine

ConditionsStroke, IschemicStroke Hemorrhagic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Any degree of receptive aphasia

Moderate or severe expressive aphasia

Currently pregnant or plans to get pregnant

Currently breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Placebo

    Drug

    placebo pills

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: AmantadineActive comparator 1 intervention

Trial outcomes

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.

Time frame
Day 90

Secondary outcomes

1

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

Time frame
90 days
2

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

Time frame
90 days
3

Digit Symbol Substitution Test (DSST) score

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

Time frame
90 Days
4

Montreal Cognitive Assessment test (MOCA) score

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

Time frame
90 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
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