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Autism Spectrum DisorderPhase 2NCT01372449

A Multi-site Double-blind Placebo-controlled Trial of Memantine Versus Placebo in Children With Autism (MEM)

A Phase 2 study testing Memantine in people with Autism Spectrum Disorder, run by Evdokia Anagnostou at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will attempt to study the effect of memantine, on memory, and motor praxis/expressive language skills in children with autism. The investigators will recruit children ages 6-12 years who are verbal and meet criteria for Autism Spectrum Disorder. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Memantine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
2 sitesUnited States
Study dates
Dec 2011to Oct 2015
Phase
Phase 2
Are there results?
None posted in the registry

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 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male or female outpatients 6 to 12 years of age
  • Verbal; Module 2 or 3 on Autism Diagnostic Observation Schedule (ADOS)
  • Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) for Autism Spectrum Disorder. The diagnosis will be confirmed with Autism Diagnostic Interview-Revised (ADI-R) and ADOS Module 2 or 3.
  • Parents report difficulties with motor skills
  • Have a Clinician's Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Screening and Baseline
  • If already receiving stable nonpharmacologic educational, behavioral, and/or dietary interventions, have continuous participation during the preceding 3 months prior to Screening and will not electively initiate new or modify ongoing interventions for the duration of the study
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  • Participants can be on up to 2 concomitant psychotropic medications before entering the study, provided that they have been on a stable dose for 30 days and have no plans to adjust the dose for the duration of study
  • Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigators
  • Prior to the conduct of any study-specific procedures, the patient must provide assent to participate in the study (if developmentally appropriate), and the parent or legal guardian must provide written informed consent
  • The patient and the patient's parent or legal guardian must be able to speak and understand English sufficiently to understand the nature of the study and to allow for the completion of all study assessments
  • The parent or legal guardian must be capable of providing reliable information about the patient's condition, agree to oversee the administration of study drug, and accompany the patient to all clinic visits

Who cannot join

  • Patients born prior to 35 weeks gestational age
  • Patients with any primary psychiatric diagnosis other than autism at Screening: a history of Attention Deficit Hyperactivity Disorder (ADHD), bipolar disorder, psychosis, post-traumatic stress disorder, schizophrenia, or major depressive disorder
  • Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain
  • Patients with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease.
  • Patients who plan to initiate or change pharmacological or nonpharmacologic interventions during the course of the study
  • Patients on d-cycloserine or riluzole as they both target the glutamate system
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  • Patients on agents that alkalinize the urine (acetazolamide, potassium citrate, and sodium bicarbonate), as they decrease the elimination of memantine
  • Patients who have received treatment with memantine in the past with no response
  • Patients with a history of hypersensitivity reaction to dextromethorphan, amantadine, or any other NMDA receptor antagonists
  • Patients unable to tolerate venipuncture procedures for blood sampling
  • Patients who, in the Investigator's opinion, might not be suitable for the study
  • Children weighing under 20 kg (to meet FDA approvals)
  • Patients with a positive pregnancy test

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Mount Sinai School of Medicine

    New York, New York, 10029

Other trials in United States

About this study

Official title: A Multi-site Double-blind Placebo-controlled Trial of Memantine Versus Placebo in Children With Autism Targeting Memory and Motor Planning

This study will attempt to study the effect of memantine, on memory, and motor praxis/expressive language skills in children with autism.

The investigators will recruit children ages 6-12 years who are verbal and meet criteria for Autism Spectrum Disorder. The children will be assessed for memory function, expressive language output and motor skills/praxis. They will then be randomized to memantine or placebo for 6 months. The effects of this medication and its safety in this population will be studied over the 6 month period.

Read the detailed description

Abnormalities in the modulation of the glutamate system have been reported by multiple investigators studying animal models, post-mortem brains, and single gene disorders that have overlapping phenotypes with autism. Abnormalities in glutamatergic function have been reported in disorders affecting a variety of behavioral and neurological domains, from mood stability, to cognitive flexibility, memory, and motor function. Numerous studies have reported a variety of memory and motor deficits in children with autism. Whereas the neurobiology of such deficits is an area of active research, there is a paucity of intervention research for such deficits in autism. This study will attempt to study the effect of an N-methyl-D-aspartate receptor (NMDA) inhibitor, memantine, on memory, and motor praxis/expressive language skills in children with autism.

Methods: Children ages 6-12 years who are verbal and meet criteria for Autism Spectrum Disorder will be recruited across 2 sites. After consent, the children will be assessed for memory function, expressive language output and motor skills/praxis. They will then be randomized 1:1 to memantine versus placebo for 6 months. The effects of this medication on the above mentioned symptoms domains as well as its safety in this population will be studied over the 6 month period.

Being tested
Memantine, Placebo
Keywords
Autism, Psychopharmacology, Clinical Trial, Children
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

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

  • MemantineDrug

    Also called Namenda

    Memantine will be initiated at 3 mg. The dose will be increased every week by 3 mg for a maximum of 12mg for subjects weighing ≥ 60kg, 9mg for subjects weighing ≥ 40 kg but <60 kg, and 6 mg for subjects weighing ≥ 20 kg but < 40kg.

  • PlaceboDrug

Study groups in NCT01372449
Study groupRoleWhat they receive
MemantineActive comparatorNot described
Receives: Drug: Memantine
PlaceboPlacebo comparatorPlacebo Comparator
Receives: Drug: Placebo

What is being measured

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

  1. Developmental Neuropsychological Assessment (NEPSY) Apraxia and Repetition of Nonsense Words Subtests

    Outcome Measure is going to report a change. The NEPSY provides a developmental neuropsychological assessment for children age 3-12. It was designed to assess basic and complex aspects of cognitive capacities that are critical to children's ability to learn and be productive both in and out of school settings

    Measured: Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)

  2. Expressive Vocabulary Test (EVT)

    Measured: Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)

Secondary outcomes (2)

  1. Vineland Adaptive Behavior Scale - Revised

    Outcome Measure is going to report a change. The Vineland Scale is a semi-structured informant interview that assesses subjects' daily functioning. It is typically administered to a caretaker/family member. This scale has been found to assess social deficits in autism and relative strengths in daily living skills.

    Measured: Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)

  2. Safety Monitoring Uniform Research Form

    The SMURF consists of three parts. Part 1 contains a "General Inquiry" to obtain all information about possible physical complaints, using general probes. Part 2 comprises "Specific Inquiries" about physical complaints, organized roughly around different body systems. Part 3 concludes with a "Closing Inquiry" in which the clinician can ask about any physical or other problems he/she has pre-existing knowledge about or which he/she noticed during the rest of the inquiry.

    Measured: Screening, Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 16, Week 20, Week 24

Timeline

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

  1. First posted14 Jun 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01372449
Sponsor's protocol ID
111576
Status last verified
Mar 2017
First submitted
2 Jun 2011
Last updated
20 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Brignell A, Marraffa C, Williams K, May T. Memantine for autism spectrum disorder. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013845. doi: 10.1002/14651858.CD013845.pub2.

    PubMed 36006807

  • Soorya LV, Fogg L, Ocampo E, Printen M, Youngkin S, Halpern D, Kolevzon A, Lee S, Grodberg D, Anagnostou E. Neurocognitive Outcomes from Memantine: A Pilot, Double-Blind, Placebo-Controlled Trial in Children with Autism Spectrum Disorder. J Child Adolesc Psychopharmacol. 2021 Sep;31(7):475-484. doi: 10.1089/cap.2021.0010.

    PubMed 34543081

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Memantine in people with Autism Spectrum Disorder, run by Evdokia Anagnostou at 2 sites 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 11 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: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Developmental Neuropsychological Assessment (NEPSY) Apraxia and Repetition of Nonsense Words Subtests (time frame: Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)). The study lists 2 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 NCT01372449, which also lists 2 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 20 Mar 2017.

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