Ischemic StrokeEarly Phase 1NCT02144584

Memantine for Enhanced Stroke Recovery

A Early Phase 1 study testing Memantine XR in people with Ischemic Stroke and Upper Extremity Weakness, run by University of Utah at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Stroke, Upper Extremity Weakness
What is being tested?: Memantine XR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jan 2014to Jun 2027
Phase: Early Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Show all 9Show fewer

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Utah
Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: Pilot Study of Memantine for Enhanced Stroke Recovery

Read the 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
Being tested: Memantine XR, Placebo (for memantine)
Keywords: ischemic stroke, memantine, upper extremity weakness, motor recovery
Medical subject headings: Ischemic Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Memantine XRDrug
Also called Namenda XR
The active drug will be encapsulated by the University of Utah Research Pharmacy to maintain blinding.
Placebo (for memantine)Drug
Also called sugar capsule
Placebo to be capsuled to look identical to active drug (memantine)

Study groups in NCT02144584
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Memantine XR

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30-90 days

Secondary outcomes (12)

Motor Activity Log (MAL)
The validity of the MAL has been well established against upper extremity accelerometry.
The Motor Activity Log is a self-report measure of how frequently the participant uses his or her paretic hand in 30 common daily activities, such as opening a drawer and shaving or putting on make-up. Participants rate how often they use the paretic UE in these tasks on a 6 point scale from 0 representing no use to 5 representing as much use as before the stroke. The quality of movement scale on the Motor Activity Log asks the participant to rate how well he or she perceives the task is performed with the paretic UE. The ratings are also made on a 6 point scale with 0 representing no use to 5 representing as well as before the stroke. This assessment will only be completed at post-intervention and follow-up as it is invalid assessment in the in-patient setting where participants have few opportunities to engage in the tested items.
Measured: 30 days
Motor Activity Log (MAL)
The validity of the MAL has been well established against upper extremity accelerometry.
The Motor Activity Log is a self-report measure of how frequently the participant uses his or her paretic hand in 30 common daily activities, such as opening a drawer and shaving or putting on make-up. Participants rate how often they use the paretic UE in these tasks on a 6 point scale from 0 representing no use to 5 representing as much use as before the stroke. The quality of movement scale on the Motor Activity Log asks the participant to rate how well he or she perceives the task is performed with the paretic UE. The ratings are also made on a 6 point scale with 0 representing no use to 5 representing as well as before the stroke. This assessment will only be completed at post-intervention and follow-up as it is invalid assessment in the in-patient setting where participants have few opportunities to engage in the tested items.
Measured: 90 days
Ten Meter Walk Test
The 10 meter walk is a measure of typical gait speed.
The participant is asked to walk at his/her usual pace for 10 meters along a hallway. Two trials are completed with the best time in seconds to walk the distance recorded. The test is reliable. We will videotape the walk and later use the Riverside Scale for rating quality of locomotion.
Measured: 30 days
Ten Meter Walk Test
The 10 meter walk is a measure of typical gait speed.
The participant is asked to walk at his/her usual pace for 10 meters along a hallway. Two trials are completed with the best time in seconds to walk the distance recorded. The test is reliable. We will videotape the walk and later use the Riverside Scale for rating quality of locomotion.
Measured: 90 days
Stroke Impact Scale (SIS)
The SIS is a self-report measure of functioning after stroke at the body function, activity, and participation levels.
Participants rate on a 5 point scale how frequently statements apply to them across 8 domains (strength, communication, emotion, hand use, activities of daily living, mobility, thinking, and social participation). Scores for each domain are tallied and converted to a 100-point scale. Scores across domains are also tallied and converted to a 100-point scale. The SIS has been shown to be reliable and valid. This assessment will only be completed at post-intervention and follow-up as many of the items concern activities that are only encountered in the community. Participants who are new inpatients will not have had the opportunity to engage in these activities.
Measured: 30 days
Stroke Impact Scale (SIS)
The SIS is a self-report measure of functioning after stroke at the body function, activity, and participation levels.
Participants rate on a 5 point scale how frequently statements apply to them across 8 domains (strength, communication, emotion, hand use, activities of daily living, mobility, thinking, and social participation). Scores for each domain are tallied and converted to a 100-point scale. Scores across domains are also tallied and converted to a 100-point scale. The SIS has been shown to be reliable and valid. This assessment will only be completed at post-intervention and follow-up as many of the items concern activities that are only encountered in the community. Participants who are new inpatients will not have had the opportunity to engage in these activities.
Measured: 90 days
Cancellation Tests
These tests measure the presence of unilateral neglect.
The letter cancellation task includes 40 target letters (E, R) among 130 non-target letters on an A4-sized landscape sheet (maximum score 40, cutoff point 32). The letters are arranged in five rows, each containing 34 items. The star cancellation task consists of 56 targets (small stars) and 75 non-targets (big stars, words, and letters) randomly spaced on an A4-sized landscape sheet. In these three cancellation tasks, participants are instructed to search and mark all the targets on the stimulus sheet. The total number of targets crossed out on the left and the right of each form will be tallied and the percentage.
Measured: 30 Days
Cancellations Tests
These tests measure the presence of unilateral neglect.
The letter cancellation task includes 40 target letters (E, R) among 130 non-target letters on an A4-sized landscape sheet (maximum score 40, cutoff point 32). The letters are arranged in five rows, each containing 34 items. The star cancellation task consists of 56 targets (small stars) and 75 non-targets (big stars, words, and letters) randomly spaced on an A4-sized landscape sheet. In these three cancellation tasks, participants are instructed to search and mark all the targets on the stimulus sheet. The total number of targets crossed out on the left and the right of each form will be tallied and the percentage.
Measured: 90 Days
Grip Strength Test
Grip strength will be tested using the American Hand Therapy Association recommended protocol.
Briefly, the participant will be seated in a straight backed chair with the paretic shoulder in neutral, elbow flexed, forearm half-way between supination and pronation. He or she grasps the Jamar-type dynamometer by the handle and squeezes it as hard as possible for 5 seconds. The tester gives the command "Ok, squeeze as hard as you can….harder…..harder…..relax". The test is repeated 2 more times with a 30 second rest in between squeezes. Grip strength will be measured as the average of the 3 trials to the nearest kilogram.
Measured: 30 Days
Grip Strength Test
Grip strength will be tested using the American Hand Therapy Association recommended protocol.
Briefly, the participant will be seated in a straight backed chair with the paretic shoulder in neutral, elbow flexed, forearm half-way between supination and pronation. He or she grasps the Jamar-type dynamometer by the handle and squeezes it as hard as possible for 5 seconds. The tester gives the command "Ok, squeeze as hard as you can….harder…..harder…..relax". The test is repeated 2 more times with a 30 second rest in between squeezes. Grip strength will be measured as the average of the 3 trials to the nearest kilogram.
Measured: 90 Days
Montreal Cognitive Assessment (MoCA©)
The MoCA© is recommended by NIH and Canadian Stroke Consortium for Cognitive Assessment after Stroke. It is reliable and valid for the stroke population.
Measured: 30 Days
Montreal Cognitive Assessment (MoCA©)
The MoCA© is recommended by NIH and Canadian Stroke Consortium for Cognitive Assessment after Stroke. It is reliable and valid for the stroke population.
Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Jun 2027

First posted22 May 2014 (estimated)
Study startJan 2014
Primary completionJun 2027 (estimated)
Study completionJun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02144584
Sponsor's protocol ID: 00068751
Status last verified: Aug 2026
First submitted: 27 Jan 2014
Last updated: 27 Aug 2026
Results posted: No
Data monitoring committee: Yes

Publications

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. No abstract available.
PubMed 23283859
Rathore SS, Hinn AR, Cooper LS, Tyroler HA, Rosamond WD. Characterization of incident stroke signs and symptoms: findings from the atherosclerosis risk in communities study. Stroke. 2002 Nov;33(11):2718-21. doi: 10.1161/01.str.0000035286.87503.31.
PubMed 12411667
Kalra L, Eade J. Role of stroke rehabilitation units in managing severe disability after stroke. Stroke. 1995 Nov;26(11):2031-4. doi: 10.1161/01.str.26.11.2031.
PubMed 7482644
Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7.
PubMed 21216670
Ziemann U, Ilic TV, Pauli C, Meintzschel F, Ruge D. Learning modifies subsequent induction of long-term potentiation-like and long-term depression-like plasticity in human motor cortex. J Neurosci. 2004 Feb 18;24(7):1666-72. doi: 10.1523/JNEUROSCI.5016-03.2004.
PubMed 14973238
Lipton SA. Failures and successes of NMDA receptor antagonists: molecular basis for the use of open-channel blockers like memantine in the treatment of acute and chronic neurologic insults. NeuroRx. 2004 Jan;1(1):101-10. doi: 10.1602/neurorx.1.1.101.
PubMed 15717010
Chen HS, Lipton SA. Mechanism of memantine block of NMDA-activated channels in rat retinal ganglion cells: uncompetitive antagonism. J Physiol. 1997 Feb 15;499 ( Pt 1)(Pt 1):27-46. doi: 10.1113/jphysiol.1997.sp021909.
PubMed 9061638
Chen HS, Pellegrini JW, Aggarwal SK, Lei SZ, Warach S, Jensen FE, Lipton SA. Open-channel block of N-methyl-D-aspartate (NMDA) responses by memantine: therapeutic advantage against NMDA receptor-mediated neurotoxicity. J Neurosci. 1992 Nov;12(11):4427-36. doi: 10.1523/JNEUROSCI.12-11-04427.1992.
PubMed 1432103
Chen HS, Wang YF, Rayudu PV, Edgecomb P, Neill JC, Segal MM, Lipton SA, Jensen FE. Neuroprotective concentrations of the N-methyl-D-aspartate open-channel blocker memantine are effective without cytoplasmic vacuolation following post-ischemic administration and do not block maze learning or long-term potentiation. Neuroscience. 1998 Oct;86(4):1121-32. doi: 10.1016/s0306-4522(98)00163-8.
PubMed 9697119
Parsons CG, Danysz W, Quack G. Memantine is a clinically well tolerated N-methyl-D-aspartate (NMDA) receptor antagonist--a review of preclinical data. Neuropharmacology. 1999 Jun;38(6):735-67. doi: 10.1016/s0028-3908(99)00019-2.
PubMed 10465680
Kilic U, Yilmaz B, Reiter RJ, Yuksel A, Kilic E. Effects of memantine and melatonin on signal transduction pathways vascular leakage and brain injury after focal cerebral ischemia in mice. Neuroscience. 2013 May 1;237:268-76. doi: 10.1016/j.neuroscience.2013.01.059. Epub 2013 Feb 8.
PubMed 23396088
LUCAS DR, NEWHOUSE JP. The toxic effect of sodium L-glutamate on the inner layers of the retina. AMA Arch Ophthalmol. 1957 Aug;58(2):193-201. doi: 10.1001/archopht.1957.00940010205006. No abstract available.
PubMed 13443577
Leveille F, El Gaamouch F, Gouix E, Lecocq M, Lobner D, Nicole O, Buisson A. Neuronal viability is controlled by a functional relation between synaptic and extrasynaptic NMDA receptors. FASEB J. 2008 Dec;22(12):4258-71. doi: 10.1096/fj.08-107268. Epub 2008 Aug 18.
PubMed 18711223
Wenk GL, Zajaczkowski W, Danysz W. Neuroprotection of acetylcholinergic basal forebrain neurons by memantine and neurokinin B. Behav Brain Res. 1997 Feb;83(1-2):129-33. doi: 10.1016/s0166-4328(97)86056-1.
PubMed 9062671
Palmer GC. Neuroprotection by NMDA receptor antagonists in a variety of neuropathologies. Curr Drug Targets. 2001 Sep;2(3):241-71. doi: 10.2174/1389450013348335.
PubMed 11554551

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Not yet recruiting
Safety of NRICM301 Added to Standard Care in Adults With Acute Ischemic Stroke
Acute Ischemic Stroke
Not yet recruitingPhase 2/3
A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
Acute Ischemic Stroke AIS
Not yet recruitingObservational study
The GEIR (Grupo español de Ictus Retina) Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion, Central Retinal Artery Occlusion
RecruitingPhase 3
Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2
Acute Ischemic Stroke

All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Memantine for Enhanced Stroke Recovery
ClinicalTrials.gov ID: NCT02144584
Acronym / sponsor ID: 00068751
Conditions: Ischemic Stroke, Upper Extremity Weakness
Keywords: ischemic stroke, memantine, upper extremity weakness, motor recovery
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 20 participants (estimated)
Lead sponsor: University of UtahUniversity, hospital or other
Study start: Jan 2014 (actual)
Primary completion: Jun 2027 (estimated)
Study completion: Jun 2027 (estimated)
First posted: 22 May 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo plus standard of care	Placebo comparator	Drug: Placebo (for memantine)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 plus standard of care	Active comparator	Drug: Memantine XRParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Memantine XRAlso: Namenda XRThe active drug will be encapsulated by the University of Utah Research Pharmacy to maintain blinding.	Drug	Memantine plus standard of care
Placebo (for memantine)Also: sugar capsulePlacebo to be capsuled to look identical to active drug (memantine)	Drug	Placebo plus standard of care

Primary outcome

Fugl-Meyer Assessment
Time frame: 30 days
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.
Fugl-Meyer Assessment
Time frame: 90 days
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.
Adverse events
Time frame: up to 30 days
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.
Adverse Events
Time frame: 30-90 days
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.

12 secondary outcomes

Motor Activity Log (MAL)
Time frame: 30 days
Motor Activity Log (MAL)
Time frame: 90 days
Ten Meter Walk Test
Time frame: 30 days
Ten Meter Walk Test
Time frame: 90 days
Stroke Impact Scale (SIS)
Time frame: 30 days
Stroke Impact Scale (SIS)
Time frame: 90 days
Cancellation Tests
Time frame: 30 Days
Cancellations Tests
Time frame: 90 Days
Grip Strength Test
Time frame: 30 Days
Grip Strength Test
Time frame: 90 Days
Montreal Cognitive Assessment (MoCA©)
Time frame: 30 Days
Montreal Cognitive Assessment (MoCA©)
Time frame: 90 Days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
Background: PubMed 23283859Go 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. No abstract available.
Background: PubMed 12411667Rathore SS, Hinn AR, Cooper LS, Tyroler HA, Rosamond WD. Characterization of incident stroke signs and symptoms: findings from the atherosclerosis risk in communities study. Stroke. 2002 Nov;33(11):2718-21. doi: 10.1161/01.str.0000035286.87503.31.
Background: PubMed 7482644Kalra L, Eade J. Role of stroke rehabilitation units in managing severe disability after stroke. Stroke. 1995 Nov;26(11):2031-4. doi: 10.1161/01.str.26.11.2031.
Background: PubMed 21216670Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7.
Background: PubMed 14973238Ziemann U, Ilic TV, Pauli C, Meintzschel F, Ruge D. Learning modifies subsequent induction of long-term potentiation-like and long-term depression-like plasticity in human motor cortex. J Neurosci. 2004 Feb 18;24(7):1666-72. doi: 10.1523/JNEUROSCI.5016-03.2004.
Background: PubMed 15717010Lipton SA. Failures and successes of NMDA receptor antagonists: molecular basis for the use of open-channel blockers like memantine in the treatment of acute and chronic neurologic insults. NeuroRx. 2004 Jan;1(1):101-10. doi: 10.1602/neurorx.1.1.101.
Background: PubMed 9061638Chen HS, Lipton SA. Mechanism of memantine block of NMDA-activated channels in rat retinal ganglion cells: uncompetitive antagonism. J Physiol. 1997 Feb 15;499 ( Pt 1)(Pt 1):27-46. doi: 10.1113/jphysiol.1997.sp021909.
Background: PubMed 1432103Chen HS, Pellegrini JW, Aggarwal SK, Lei SZ, Warach S, Jensen FE, Lipton SA. Open-channel block of N-methyl-D-aspartate (NMDA) responses by memantine: therapeutic advantage against NMDA receptor-mediated neurotoxicity. J Neurosci. 1992 Nov;12(11):4427-36. doi: 10.1523/JNEUROSCI.12-11-04427.1992.
Background: PubMed 9697119Chen HS, Wang YF, Rayudu PV, Edgecomb P, Neill JC, Segal MM, Lipton SA, Jensen FE. Neuroprotective concentrations of the N-methyl-D-aspartate open-channel blocker memantine are effective without cytoplasmic vacuolation following post-ischemic administration and do not block maze learning or long-term potentiation. Neuroscience. 1998 Oct;86(4):1121-32. doi: 10.1016/s0306-4522(98)00163-8.
Background: PubMed 10465680Parsons CG, Danysz W, Quack G. Memantine is a clinically well tolerated N-methyl-D-aspartate (NMDA) receptor antagonist--a review of preclinical data. Neuropharmacology. 1999 Jun;38(6):735-67. doi: 10.1016/s0028-3908(99)00019-2.
Background: PubMed 23396088Kilic U, Yilmaz B, Reiter RJ, Yuksel A, Kilic E. Effects of memantine and melatonin on signal transduction pathways vascular leakage and brain injury after focal cerebral ischemia in mice. Neuroscience. 2013 May 1;237:268-76. doi: 10.1016/j.neuroscience.2013.01.059. Epub 2013 Feb 8.
Background: PubMed 13443577LUCAS DR, NEWHOUSE JP. The toxic effect of sodium L-glutamate on the inner layers of the retina. AMA Arch Ophthalmol. 1957 Aug;58(2):193-201. doi: 10.1001/archopht.1957.00940010205006. No abstract available.

Related trials for Ischemic Stroke

Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Not yet recruiting
Safety of NRICM301 Added to Standard Care in Adults With Acute Ischemic Stroke
Acute Ischemic Stroke
Not yet recruitingPhase 2/3
A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
Acute Ischemic Stroke AIS
Not yet recruitingObservational study
The GEIR (Grupo español de Ictus Retina) Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion, Central Retinal Artery Occlusion
RecruitingPhase 3
Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2
Acute Ischemic Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alicia Bennett, D.O. principal investigator

University of Utah

Jennifer Majersik, M.D. principal investigator

University of Utah

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Memantine XR in people with Ischemic Stroke and Upper Extremity Weakness, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02144584, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.