Cortical Metrics Assessment Outcome Measure Development in Autism With Memantine Treatment
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|ClinicalTrials.gov Identifier: NCT02353130|
Recruitment Status : Withdrawn (Protocol did not continue once Investigator relocated to another institution)
First Posted : February 2, 2015
Last Update Posted : May 8, 2017
Specific Aim 1: Obtain proof of concept evidence that cortical metrics will change in response to treatment with Memantine extended release (XR)®, an agent that modulates n-methyl d-asptartate (NMDA) receptor activation, in children with autism spectrum disorders (ASD) who clinically demonstrate treatment response.
Hypothesis1: Children with ASD who have dramatic clinical response to Memantine XR® will exhibit changes in their cortical metrics, which will differ less from neurotypical children. Subjective ratings of improvement will be correlated with the change in cortical metrics.
The completion of these aims will be essential to design a larger federally funded trial to validate cortical metrics as an outcome measure in a more heterogeneous pediatric ASD sample. Specifically, the feasibility data obtained may demonstrate the potential for detecting changes in cortical metrics over time, so that a larger grant could focus on determining how sensitive and clinically relevant changes in cortical metrics are or may indicate the need to explore different interventions to use in a validation study. We have chosen to use Memantine XR® because of its impact on NMDA neurotransmission, its current evaluation in a large multi-site randomized ASD clinical trial whose initial results are expected shortly, and our own observations of clinical improvements and good tolerability in the ongoing trial.
|Condition or disease||Intervention/treatment|
|Autism Spectrum Disorders||Drug: Memantine-XR|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Development Of Cortical Metrics Assessment Outcome Measures in Response to Memantine Treatment in Autism Spectrum Disorders|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Boys ages 8-12 with ASD treated with Memantine-XR daily for 8 weeks
Participants will begin with 7mg Memantine XR® daily for a minimum of one week before increasing to an optimal dose of 14 mg daily. It is suggested that participants be titrated to the optimal dose by week 2 so that they may remain on 14mg for at least 6 weeks. Morning dosing is suggested, but can be flexible.
Other Name: Namenda-XR
- cortical metrics (a mathematical plot of tactile responsivity in 3 dimensions) [ Time Frame: 8 weeks ]a mathematical plot of tactile responsivity in 3 dimensions
- Clinical Global Impressions - Improvement Score. [ Time Frame: 8 weeks ]ratings of 1 or 2 indicate clinically meaningful response
- PDD-BI SV change 0-8 [ Time Frame: 8 weeks ]18 item caregiver completed questionnaire about social functioning
- ABC-SW subscale score 0-8 [ Time Frame: 8 weeks ]13 item caregiver completed questionnaire about social problems
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): NCT02353130
|Principal Investigator:||Linmarie Sikich, MD||University of North Carolina, Chapel Hill|