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NMDA Receptor Antagonist
Memantine XR for Stroke
Phase < 1
Waitlist Available
Led By Alicia Bennett, D.O.
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-90 days
Summary
This trial will test a new drug for people who have had a stroke and have weak arms. The trial is double blind, meaning neither the participants nor the researchers will know who is getting the drug or the placebo.
Who is the study for?
This trial is for adults over 18 who lived independently before having an ischemic stroke, can swallow pills, and have arm weakness needing therapy. They must be within 3 days to 8 weeks of their stroke, able to move the affected arm, and have a confirmed supratentorial stroke with certain Fugl-Meyer scores.
What is being tested?
The study tests if Memantine XR helps in recovery from acute ischemic stroke compared to a placebo. Participants are randomly assigned to either the drug or placebo group without knowing which one they receive (double-blind).
What are the potential side effects?
While not specified here, common side effects of Memantine may include dizziness, headache, confusion, constipation. Since it's being tested post-stroke for recovery enhancement rather than dementia treatment as usual, monitoring will be essential.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30-90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Adverse events
Fugl-Meyer Assessment
Secondary study objectives
Cancellation Tests
Cancellations Tests
Grip Strength Test
+4 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Memantine plus standard of careActive Control1 Intervention
Participants will start taking either memantine or placebo within 24 hours after baseline testing and randomization is completed, but no later than day 8 post-symptom onset. Participants will use a titration schedule starting at 7mg daily for 1 week, increasing by 7mg (1 capsule) per week until at a goal dose of 28mg daily (goal dose) as recommend by the manufacturer. Participants will continue memantine for 90 days. Continue with standard care for stroke.
Group II: Placebo plus standard of carePlacebo Group1 Intervention
Participants will start taking either memantine or placebo within 24 hours after baseline testing and randomization is completed, but no later than day 8 post-symptom onset. Participants will titrate up on the dose of placebo until taking twice daily. Participants will continue for 90 days with placebo. Continue with standard of care for other treatment of stroke.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,697,779 Total Patients Enrolled
20 Trials studying Stroke
3,457 Patients Enrolled for Stroke
Alicia Bennett, D.O.Principal InvestigatorUniversity of Utah
Jennifer Majersik, M.D.Principal InvestigatorUniversity of Utah
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are very sick and not expected to live for another 6 months.You have a neurological condition such as Multiple Sclerosis, spinal cord disease, or brain cancer that could affect the study results.You have severe liver problems or hepatitis.You are older than 18 years.You have a history of dementia that would make it hard for you to recover.You have used memantine or amantadine before or after having a stroke.You have bleeding in the brain from a specific type of stroke.The stroke occurred in the lower part of the brain (brainstem or cerebellum).Your stroke severity score is very high.You have reasons that make it unsafe for you to take memantine XR in pill form.You had a stroke in the past and still have symptoms on the same side that could affect the results of this study.You have very severe kidney problems, which will be checked with a blood test before the study.Your arm weakness is so bad that you need occupational therapy either in the hospital or outside the hospital.You can move your affected arm voluntarily.You have had a stroke confirmed by a brain MRI or CT scan.The stroke occurred in the upper part of the brain.Your arm and leg movement scores are lower than a certain number on a test called Fugl-Meyer.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo plus standard of care
- Group 2: Memantine plus standard of care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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