Cortical Metrics Assessment Outcome Measure Development in Autism With Memantine Treatment

NCT02353130 | Withdrawn

• 1 other identifier: 14-1996
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Autism Spectrum Disorders

Keywords

autism spectrum disorders; memantine; cortical metrics; sensory testing

Outcome Measures

Primary Outcomes (1)

• cortical metrics (a mathematical plot of tactile responsivity in 3 dimensions)

  a mathematical plot of tactile responsivity in 3 dimensions

  8 weeks

Secondary Outcomes (3)

• Clinical Global Impressions - Improvement Score.

  8 weeks

• PDD-BI SV change 0-8

  8 weeks

• ABC-SW subscale score 0-8

  8 weeks

Study Arms (1)

Memantine-XR

Boys ages 8-12 with ASD treated with Memantine-XR daily for 8 weeks

Drug: Memantine-XR

Interventions

Memantine-XR DRUG

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.

Also known as: Namenda-XR

Memantine-XR

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

15 boys with ASD (8-12 years old) will receive Memantine XR®.

You may qualify if:

• Male Boys ages 8-12 with ASD (confirmed with ADOS-2 and DSM-5 checklist at screening)
• IQ's should be within the normal range (≥ 70) (by prior testing or Stanford-Binet 5 at screening)
• Primary caretaker is able to participate in study appointments as is clinically indicated.
• Ability of child to participate in all aspects of the protocol per investigator clinical judgment

You may not qualify if:

• No new educational or behavioral intervention within 4 weeks of baseline.
• No history of non-febrile seizures, other neurological disorders, or comorbid psychiatric disorders.
• Impairment of renal function
• Evidence or history of malignancy
• Any significant medical conditions including but not limited to hematological, endocrine, respiratory, hepatic, cardiovascular or gastrointestinal disease
• Patients who, in the investigator's opinion, might not be suitable for the study
• Significant risk of suicidality based on investigator judgment
• History of hypersensitivity reaction to Memantine, dextromethorphan, amantadine or any other NMDA antagonists
• Changes in psychotropic medications within 4 weeks of baseline visit

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Related Publications (1)

• 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.

  PMID: 36006807 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Memantine

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Linmarie Sikich, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 2, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 8, 2017

Record last verified: 2015-10