A Trial of Memantine Versus Placebo in Children With Autism
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 2014|
|Estimated Primary Completion Date:||February 2014 (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.
|Contact: Dina Zaghloul, B.MSc||416-425-6220 ext email@example.com|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Natalie Forburger, MA 312-563-2272 firstname.lastname@example.org|
|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 Helton, RN 614-722-2607 email@example.com|
|Contact: Christine Hapanowicz, CCRP 614-722-2605 firstname.lastname@example.org|
|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|