A Multi-site Double-blind Placebo-controlled Trial of Memantine Versus Placebo in Children With Autism (MEM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01372449|
Recruitment Status : Completed
First Posted : June 14, 2011
Last Update Posted : March 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Drug: Memantine Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multi-site Double-blind Placebo-controlled Trial of Memantine Versus Placebo in Children With Autism Targeting Memory and Motor Planning|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
|Active Comparator: Memantine||
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.
Other Name: Namenda
Placebo Comparator: Placebo
- 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) ]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
- Expressive Vocabulary Test (EVT) [ Time Frame: Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial) ]
- Vineland Adaptive Behavior Scale - Revised [ Time Frame: Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial) ]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.
- Safety Monitoring Uniform Research Form [ Time Frame: Screening, Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 16, Week 20, Week 24 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372449
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Study Chair:||Evdokia Anagnostou, M.D.||Holland Bloorview Kids Rehabilitation Hospital|
|Principal Investigator:||Latha V Soorya, Ph.D.||Rush University Medical Center|
|Principal Investigator:||David Grodberg, M.D.||Icahn School of Medicine at Mount Sinai|