Memantine for Enhanced Stroke Recovery

Recruiting

Phase Early 1 Results N/A

Trial 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

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.

Conditions

Interventions

  • Memantine (Ebixa)Drug
    Intervention Desc: The active drug will be encapsulated by the University of Utah Research Pharmacy to maintain blinding.
    ARM 1: Kind: Experimental
    Label: Memantine plus standard of care
    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 5mg daily for 1 week, followed by 5mg twice daily for 1 week, then 10mg every morning and 5mg every evening for 1 week and finally 10mg twice daily (goal dose) as recommend by the manufacturer. Participants will continue memantine for 90 days. Continue with standard care for stroke.
  • Placebo (for memantine) Drug
    Other Names: sugar capsule
    Intervention Desc: Placebo to be capsuled to look identical to active drug (memantine)
    ARM 1: Kind: Experimental
    Label: Placebo plus standard of care
    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.
  • Memantine XR Drug
    Other Names: Namenda XR
    Intervention Desc: The active drug will be encapsulated by the University of Utah Research Pharmacy to maintain blinding.
    ARM 1: Kind: Experimental
    Label: Memantine plus standard of care
    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.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment 30 days No
Primary Adverse events up to 30 days Yes
Secondary Motor Activity Log (MAL) 30 days No
Secondary Ten Meter Walk Test 30 days No
Secondary Stroke Impact Scale (SIS) 30 days No
Secondary Cancellation Tests 30 Days No
Secondary Cancellations Tests 90 Days No
Secondary Grip Strength Test 30 Days No
Secondary Montreal Cognitive Assessment (MoCA©) 30 Days No

Sponsors