Ischemic Stroke | Memantine for Enhanced Stroke Recovery
Ischemic Stroke research study
What is the primary objective of this study?
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
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Upper Extremity Weakness
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Memantine XRThe active drug will be encapsulated by the University of Utah Research Pharmacy to maintain blinding.
Drug:Placebo (for memantine)Placebo to be capsuled to look identical to active drug (memantine)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Placebo plus standard of careParticipants 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.
Memantine plus standard of careParticipants 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.
Start Date: January 2014
Completed Date: December 2018
Phase: Early Phase 1
Primary Outcome: Fugl-Meyer Assessment
Secondary Outcome: Motor Activity Log (MAL)
Study sponsors, principal investigator, and references
Principal Investigator: Alicia Bennett, D.O.
Lead Sponsor: University of Utah
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):143-52. doi: 10.1161/CIR.0b013e318282ab8f. Review.