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Memantine for Enhanced Stroke Recovery

Information source: University of Utah
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ischemic Stroke; Upper Extremity Weakness

Intervention: Memantine (Drug); Placebo (for memantine) (Drug)

Phase: Phase 0

Status: Recruiting

Sponsored by: University of Utah

Official(s) and/or principal investigator(s):
Alicia Bennett, D.O., Principal Investigator, Affiliation: University of Utah
Jennifer Majersik, M.D., Principal Investigator, Affiliation: University of Utah

Overall contact:
Alicia Bennett, D.O., Phone: 801-585-2033, Email: alicia.bennett@hsc.utah.edu


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.

Clinical Details

Official title: Pilot Study of Memantine for Enhanced Stroke Recovery

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Fugl-Meyer Assessment

Fugl-Meyer Assessment

Adverse events

Adverse Events

Secondary outcome:

Motor Activity Log (MAL)

Motor Activity Log (MAL)

Ten Meter Walk Test

Ten Meter Walk Test

Stroke Impact Scale (SIS)

Stroke Impact Scale (SIS)

Cancellation Tests

Cancellations Tests

Grip Strength Test

Grip Strength Test

Montreal Cognitive Assessment (MoCA©)

Montreal Cognitive Assessment (MoCA©)


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


Inclusion Criteria: 1. Age 18-80 years old 2. Randomization between 3-8 days of stroke symptom onset 3. Arm weakness severe enough to warrant inpatient or outpatient occupational therapies 4. Able to voluntarily move the wrist or a digit of the 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 Score of 55 or less 9. Ability to swallow pills Exclusion Criteria: 1. Hemorrhagic stroke, subarachnoid hemorrhage, or other cause of symptoms other than ischemic 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 in pill form 7. History of prior clinical stroke 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

Locations and Contacts

Alicia Bennett, D.O., Phone: 801-585-2033, Email: alicia.bennett@hsc.utah.edu

University of Utah, Salt Lake City, Utah 84132, United States; Recruiting
Alicia Bennett, D.O., Principal Investigator
Jennifer Majersik, M.D., Principal Investigator
Lorie Richards, Ph.D., OTR/L, Sub-Investigator
Jana Wold, M.D., Sub-Investigator
Dana DeWitt, M.D., Sub-Investigator
Peter Hannon, M.D., Sub-Investigator
Aleks Tkach, M.D., Sub-Investigator
Tina Burton, M.D., Sub-Investigator
Kevin Brennan, M.D., Sub-Investigator
Julie Martinez, RN, Sub-Investigator
Suyi Niu, Sub-Investigator
Haimei Wang, Sub-Investigator
Steve Edgley, M.D., Sub-Investigator
Edward DiBella, PhD, Sub-Investigator
Abby DeLawder, Sub-Investigator
Connie Keith, Sub-Investigator
Gina McDonald, Sub-Investigator
David Scott, Sub-Investigator
Christopher Walter, Sub-Investigator
Additional Information

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Starting date: January 2014
Last updated: May 19, 2014

Page last updated: August 23, 2015

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