A Multi-site Double-blind Placebo-controlled Trial of Memantine Versus Placebo in Children With Autism Targeting Memory and Motor Planning (MEM)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multi-site Double-blind Placebo-controlled Trial of Memantine Versus Placebo in Children With Autism Targeting Memory and Motor Planning|
- 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) ] [ Designated as safety issue: No ]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.
- Vineland Adaptive Behavior Scale - Revised [ Time Frame: Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
|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|
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 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 3 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372449
|Contact: Dina Zaghloul, B.MSc||416-425-6220 ext firstname.lastname@example.org|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Sarah E Youngkin, MPH 312-942-5431 email@example.com|
|Principal Investigator: Latha V Soorya, PhD|
|United States, New York|
|Mount Sinai School of Medicine||Recruiting|
|New York, New York, United States, 10029|
|Contact: Lauren Bush, BA 212-241-2826 firstname.lastname@example.org|
|Principal Investigator: David Grodberg, MD|
|United States, Ohio|
|Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Contact: Melinda R Smith, RN 614-722-2607 email@example.com|
|Principal Investigator: Daniel L Coury, MD|
|Sub-Investigator: Eric Butter, PhD|
|Study Chair:||Evdokia Anagnostou, MD||Holland Bloorview Kids Rehabilitation Hospital|
|Principal Investigator:||Latha V Soorya, PhD||Rush University Medical Center|
|Principal Investigator:||David Grodberg, MD||Mount Sinai School of Medicine|
|Principal Investigator:||Daniel L Coury, MD||Nationwide Children's Hospital|
|Principal Investigator:||Eric Butter, PhD||Nationwide Children's Hospital|
|Principal Investigator:||Joel Bregman, MD||The Center for Autism|