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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Recruitment Status : Withdrawn (Protocol did not continue once Investigator relocated to another institution)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
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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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.


Condition or disease Intervention/treatment
Autism Spectrum Disorders Drug: Memantine-XR

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 Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: Namenda-XR


Outcome Measures
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Primary Outcome Measures :
  1. cortical metrics (a mathematical plot of tactile responsivity in 3 dimensions) [ Time Frame: 8 weeks ]
    a mathematical plot of tactile responsivity in 3 dimensions


Secondary Outcome Measures :
  1. Clinical Global Impressions - Improvement Score. [ Time Frame: 8 weeks ]
    ratings of 1 or 2 indicate clinically meaningful response

  2. PDD-BI SV change 0-8 [ Time Frame: 8 weeks ]
    18 item caregiver completed questionnaire about social functioning

  3. ABC-SW subscale score 0-8 [ Time Frame: 8 weeks ]
    13 item caregiver completed questionnaire about social problems


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
15 boys with ASD (8-12 years old) will receive Memantine XR®.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Linmarie Sikich, MD University of North Carolina, Chapel Hill
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02353130    
Other Study ID Numbers: 14-1996
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: October 2015
Keywords provided by University of North Carolina, Chapel Hill:
autism spectrum disorders
memantine
cortical metrics
sensory testing
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Memantine
Antiparkinson Agents
 Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents