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NMDA Receptor Antagonist
Memantine XR for Stroke
Phase < 1
Waitlist Available
Led By Jennifer Majersik, M.D.
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
Awards & highlights
Study 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.
Eligible Conditions
- Ischemic Stroke
- Stroke
- Arm Weakness
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Adverse events
Fugl-Meyer Assessment
Secondary outcome measures
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
1,094 Previous Clinical Trials
1,775,497 Total Patients Enrolled
4 Trials studying Ischemic Stroke
1,370 Patients Enrolled for Ischemic Stroke
Jennifer Majersik, M.D.Principal InvestigatorUniversity of Utah
Alicia Bennett, D.O.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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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