NCT02144584

Memantine for Enhanced Stroke Recovery

Pilot Study of Memantine for Enhanced Stroke Recovery

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke
• Upper Extremity Weakness

Interventions

Type	Name	Description
DRUG	Memantine XR	The 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)

Timeline

• Start date: 2014-01-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2014-05-22
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States