Memantine for Enhanced Stroke Recovery

Utah System of Higher Education (USHE)

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Upper Extremity Weakness; Ischemic Stroke

Treatments: Drug: Placebo (for memantine); Drug: Memantine XR

Study type: Interventional

Funder types: Other

Identifiers

NCT02144584

00068751

Details and patient eligibility

About

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

Full description

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, complete therapy, and complete outcomes assessments at baseline, 4, and 12 weeks post-stroke. Target enrollment will be 10 patients per group and adaptive randomization will be used to assist with equal representation of pre-stroke selective serotonin reuptake inhibitor (SSRI) use and motor severity (Fugl-Meyer score) in each arm. 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 each group in order to power a larger efficacy trial at the University of Utah. An intention to treat model will be used during the study.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >18 years old
2. Randomization between 3 days-8 weeks days of stroke symptom onset
3. Arm weakness severe enough to warrant inpatient or outpatient occupational therapies
4. Able to voluntarily move affected UE
5. Living independently prior to their stroke
6. Image-confirmed ischemic stroke (MRI or CT)
7. Supratentorial location of stroke
8. Fugl-Meyer Upper Extremity Score of 50 or less and/or Fugl Meyer Lower Extremity Score of 28 or less
9. Ability to swallow pills

Exclusion criteria

1. subarachnoid hemorrhage, subdural hemorrhage or other cause of symptoms other than ischemic or hemorrhagic stroke
2. Infratentorial location of stroke (brainstem or cerebellum)
3. NIH Stroke Scale >20 at the time of randomization
4. History of dementia that will interfere with rehabilitation
5. Pre or post-stroke use of memantine or amantadine
6. Contraindications to taking memantine XR in pill form
7. History of prior clinical stroke with residual symptoms on the same side as the current symptoms that would interfere with outcomes of this study
8. Documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment if not done as part of clinical care.
9. Moribund or not expected to live 6 months
10. Severe cognitive deficits or pre-morbid function causing inaccurate neurologic assessment or inability to complete the initial assessment
11. Comorbid neurologic disease that would interfere with the results including but not limited to Multiple Sclerosis, neurodegenerative diseases, spinal cord disease, and central nervous system cancer.
12. Documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease (hepatitis)
13. Patients who are pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Placebo plus standard of care

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo (for memantine)

Memantine plus standard of care

Active Comparator group

Description:

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.

Treatment:

Drug: Memantine XR