Clinical trial NCT02144584: Memantine for Enhanced Stroke Recovery
Official title: Pilot Study of Memantine for Enhanced Stroke Recovery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Ischemic Stroke
Upper Extremity Weakness
Keywords: ischemic stroke
memantine
upper extremity weakness
motor recovery
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: 30 days
measure: Fugl-Meyer Assessment
timeFrame: 90 days
measure: Adverse events
timeFrame: up to 30 days
measure: Adverse Events
timeFrame: 30-90 days
Secondary outcomes:
measure: Motor Activity Log (MAL)
timeFrame: 30 days
measure: Motor Activity Log (MAL)
timeFrame: 90 days
measure: Ten Meter Walk Test
timeFrame: 30 days
measure: Ten Meter Walk Test
timeFrame: 90 days
measure: Stroke Impact Scale (SIS)
timeFrame: 30 days
measure: Stroke Impact Scale (SIS)
timeFrame: 90 days
measure: Cancellation Tests
timeFrame: 30 Days
measure: Cancellations Tests
timeFrame: 90 Days
measure: Grip Strength Test
timeFrame: 30 Days
measure: Grip Strength Test
timeFrame: 90 Days
measure: Montreal Cognitive Assessment (MoCA©)
timeFrame: 30 Days
measure: Montreal Cognitive Assessment (MoCA©)
timeFrame: 90 Days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Alicia Bennett, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Jennifer Majersik, M.D.
role: PRINCIPAL_INVESTIGATOR
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