Memantine for Enhanced Stroke Recovery

NCT02144584 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: 00068751
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Ischemic Stroke; Upper Extremity Weakness

Keywords

ischemic stroke; memantine; upper extremity weakness; motor recovery

Outcome Measures

Primary Outcomes (4)

• Fugl-Meyer Assessment

  Fugl-Meyer Assessment UE and LE scales (FMUE and FMLE). Our primary outcome measures will be the scores on the FMUE and FMLE as they have been shown to have good reliability and validity. These scales measure motor impairment by asking the participant to perform various arm, hand, and leg motions. Items are scored on a 3-point scale with 0 representing no movement, 1 representing the inability to complete the entire item and 2 representing ability to complete the item as asked. Scores range from 0-66 on the FMUE and 0-34 on the FMLE with higher scores indicating better motor control. In addition, the proprioception subscale of the FM will be used to assess status of proprioception in the UE and LE. The hip, knee, ankle, big toe, shoulder, elbow, wrist, and the thumb are moved passively and the participant is asked to indicate in which direction the joint was moved.

  30 days

• Fugl-Meyer Assessment

  Fugl-Meyer Assessment UE and LE scales (FMUE and FMLE). Our primary outcome measures will be the scores on the FMUE and FMLE as they have been shown to have good reliability and validity. These scales measure motor impairment by asking the participant to perform various arm, hand, and leg motions. Items are scored on a 3-point scale with 0 representing no movement, 1 representing the inability to complete the entire item and 2 representing ability to complete the item as asked. Scores range from 0-66 on the FMUE and 0-34 on the FMLE with higher scores indicating better motor control. In addition, the proprioception subscale of the FM will be used to assess status of proprioception in the UE and LE. The hip, knee, ankle, big toe, shoulder, elbow, wrist, and the thumb are moved passively and the participant is asked to indicate in which direction the joint was moved.

  90 days

• Adverse events

  Participants will be contacted by the stroke research nurse after weeks 1, 2, 3, and 8 of after randomization by telephone call or inpatient visit (if in the hospital or acute inpatient rehabilitation). Participants will be asked about potential adverse events during each phone call and each clinic visit. All adverse events, serious and minor, will be recorded on an adverse event table. The study investigators will review study records after every 5 participants are enrolled to monitor for patterns of adverse events to evaluate the safety of continuing the study.

  up to 30 days

• Adverse Events

  Participants will be contacted by the stroke research nurse after weeks 1, 2, 3, and 8 of after randomization by telephone call or inpatient visit (if in the hospital or acute inpatient rehabilitation). Participants will be asked about potential adverse events during each phone call and each clinic visit. All adverse events, serious and minor, will be recorded on an adverse event table. The study investigators will review study records after every 5 participants are enrolled to monitor for patterns of adverse events to evaluate the safety of continuing the study.

  30-90 days

Secondary Outcomes (12)

• Motor Activity Log (MAL)

  30 days

• Motor Activity Log (MAL)

  90 days

• Ten Meter Walk Test

  30 days

• Ten Meter Walk Test

  90 days

• Stroke Impact Scale (SIS)

  30 days

Study Arms (2)

Placebo plus standard of care

PLACEBO COMPARATOR

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.

Drug: Placebo (for memantine)

Memantine plus standard of care

ACTIVE COMPARATOR

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.

Drug: Memantine XR

Interventions

Memantine XR DRUG

The active drug will be encapsulated by the University of Utah Research Pharmacy to maintain blinding.

Also known as: Namenda XR

Memantine plus standard of care

Placebo (for memantine) DRUG

Placebo to be capsuled to look identical to active drug (memantine)

Also known as: sugar capsule

Placebo plus standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years old
• Randomization between 3 days-8 weeks days of stroke symptom onset
• Arm weakness severe enough to warrant inpatient or outpatient occupational therapies
• Able to voluntarily move affected UE
• Living independently prior to their stroke
• Image-confirmed ischemic stroke (MRI or CT)
• Supratentorial location of stroke
• Fugl-Meyer Upper Extremity Score of 50 or less and/or Fugl Meyer Lower Extremity Score of 28 or less
• Ability to swallow pills

You may not qualify if:

• subarachnoid hemorrhage, subdural hemorrhage or other cause of symptoms other than ischemic or hemorrhagic stroke
• Infratentorial location of stroke (brainstem or cerebellum)
• NIH Stroke Scale \>20 at the time of randomization
• History of dementia that will interfere with rehabilitation
• Pre or post-stroke use of memantine or amantadine
• Contraindications to taking memantine XR in pill form
• History of prior clinical stroke with residual symptoms on the same side as the current symptoms that would interfere with outcomes of this study
• 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.
• Moribund or not expected to live 6 months
• Severe cognitive deficits or pre-morbid function causing inaccurate neurologic assessment or inability to complete the initial assessment
• 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.
• Documented severe hepatic impairment (Child-Pugh score \> 6) or severe hepatic disease (hepatitis)
• Patients who are pregnant or breast feeding

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

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MeSH Terms

Conditions

Ischemic Stroke; Paresis

Interventions

Memantine; Sugars

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates

Study Officials

• Alicia Bennett, D.O.

  University of Utah

  PRINCIPAL INVESTIGATOR

• Jennifer Majersik, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: May 22, 2014
• Study Start: January 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)