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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the drug Memantine XR can improve arm strength in individuals who have recently experienced an ischemic stroke, which occurs due to a blockage in blood flow to the brain. Participants will be randomly assigned to take either Memantine XR or a placebo (a pill with no active medicine) alongside their regular stroke care. The trial seeks individuals who have had a stroke within the past few weeks and are experiencing significant arm weakness that impacts daily activities. As an Early Phase 1 trial, this research aims to understand how Memantine XR functions in people, offering participants the opportunity to contribute to groundbreaking stroke recovery science.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using memantine or amantadine. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that Memantine XR is likely to be safe for humans?

Research shows that memantine XR could aid stroke recovery. Previous studies have found that memantine improves scores on tests measuring stroke recovery, such as the NIHSS (which assesses stroke severity) and the Barthel index (which evaluates daily living skills).

Regarding safety, memantine has been tested in individuals with conditions like Alzheimer's disease. These studies assessed safety by examining side effects, vital signs, and lab results. Memantine was generally well-tolerated, with most participants not experiencing serious side effects.

The specific trial for stroke is in its early stages. While encouraging information exists from other uses, the safety for stroke patients remains under investigation. If memantine is already FDA-approved for other uses, it suggests a good safety record, but more information is needed for stroke patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard stroke treatments that focus mainly on restoring blood flow or preventing further clots, Memantine XR offers a different approach by targeting the brain's NMDA receptors. This is particularly exciting because overactivation of these receptors can lead to brain damage after a stroke. By modulating these receptors, Memantine XR could potentially protect brain cells and improve recovery outcomes. Researchers are hopeful that this unique mechanism might enhance recovery in stroke patients more effectively than current options.

What evidence suggests that Memantine XR might be an effective treatment for stroke?

Research has shown that memantine XR, which participants in this trial may receive, might aid recovery after an ischemic stroke. Studies have found that memantine can enhance recovery by improving scores on tests measuring stroke severity and daily living skills. Researchers believe it boosts levels of brain-derived neurotrophic factor, a protein that supports brain health. Memantine possesses properties that may protect the brain from further damage post-stroke. Additionally, some animal studies suggest that memantine could help heal brain damage caused by a stroke. ^{1 2 6 7 8}

Who Is on the Research Team?

Alicia Bennett, D.O.

Principal Investigator

University of Utah

Jennifer Majersik, M.D.

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9893121/

Memantine as a neuroprotective agent in ischemic stroke The available clinical trials of high-dose memantine in patients poststroke have found that it can improve patients' NIHSS and Barthel index and help patients ...

2. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.113.004476?doi=10.1161/STROKEAHA.113.004476

Memantine Enhances Recovery From Stroke Our results suggest that memantine improves stroke outcomes in an apparently non-neuroprotective manner involving increased brain-derived neurotrophic factor ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02144584

NCT02144584 | Memantine for Enhanced Stroke Recovery The primary purpose of this pilot study is to measure adverse events, drop-out rates, feasibility of trial conductance, and establishment of effect sizes in ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0967586821003003

The effects of memantine on the serum concentrations ... Memantine was suggested as a promising treatment for stroke due to its neuroprotective property and efficacy in reducing ischemic brain injury.

5. neurologylive.com neurologylive.com/view/memantine-and-recovery-after-stroke

Memantine and Recovery After Stroke A recent mouse study 1 has indicated that memantine, an Alzheimer disease medication, could aid in recovery from the damage caused by stroke.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0028390823003271

Memantine: Updating a rare success story in pro-cognitive ... Considered one of the rare exceptions, memantine has consistently demonstrated restorative and prophylactic properties in many AD models.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00322153

NCT00322153 | A Study of the Safety and Efficacy ... The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe AD on a ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2010/022525orig1s000medr.pdf

22-525 MEDICAL REVIEW(S) - accessdata.fda.gov Safety outcome measures in the majority of these studies included adverse events, vital signs, safety laboratory tests, and electrocardiograms.