Memantine XR for Stroke

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Utah

Must not be taking: Memantine, Amantadine

Disqualifiers: Dementia, Severe renal impairment, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and upper extremity weakness are randomized to either drug or placebo

Research Team

Alicia Bennett, D.O.

Principal Investigator

University of Utah

Jennifer Majersik, M.D.

Principal Investigator

University of Utah

Eligibility Criteria

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.

Inclusion Criteria

Living independently prior to their stroke

Randomization between 3 days-8 weeks days of stroke symptom onset

Ability to swallow pills

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either memantine or placebo, titrating up to a goal dose, for 90 days

12 weeks

Weekly visits (in-person or virtual) for adverse event monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Memantine XR
• Placebo (for memantine)

Trial Overview 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).

Participant Groups

Group I: Memantine plus standard of care Active Control 1 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 care Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+