Cortical Metrics Assessment Outcome Measure Development in Autism With Memantine Treatment

May 3, 2017 updated by: University of North Carolina, Chapel Hill

Development Of Cortical Metrics Assessment Outcome Measures in Response to Memantine Treatment in Autism Spectrum Disorders

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Youth with ASD ages 8-12 years will undergo cortical metrics testing (testing of ability to discriminate the vibration of small brushes on the tops of the hand under various conditions) prior to treatment with memantine XR. They will then be treated with memantine XR target dose of 14milligrams daily for 8 weeks. At the end of 8 weeks, cortical metrics testing will be repeated. Within-subject changes in the cortical metrics testing between baseline and endpoint will be examined and described. Potential relationships between changes in clinical rating scales and cortical metrics will be examined. Data will be utilized to inform a decision about continuing to explore the utility of cortical metrics to detect changes in brain function in youth with ASD in response to therapeutic interventions.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Memantine-XR
Boys ages 8-12 with ASD treated with Memantine-XR daily for 8 weeks
Drug: Memantine-XR
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 Names:
  • Namenda-XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cortical metrics (a mathematical plot of tactile responsivity in 3 dimensions)
Time Frame: 8 weeks
a mathematical plot of tactile responsivity in 3 dimensions
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impressions - Improvement Score.
Time Frame: 8 weeks
ratings of 1 or 2 indicate clinically meaningful response
8 weeks
PDD-BI SV change 0-8
Time Frame: 8 weeks
18 item caregiver completed questionnaire about social functioning
8 weeks
ABC-SW subscale score 0-8
Time Frame: 8 weeks
13 item caregiver completed questionnaire about social problems
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Linmarie Sikich, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1996

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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