Autism Spectrum DisordersNCT02353130
Cortical Metrics Assessment Outcome Measure Development in Autism With Memantine Treatment
An observational study of Autism Spectrum Disorders, run by University of North Carolina, Chapel Hill.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years, men only
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Memantine-XR
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- Men only
- No healthy volunteers
- Child
Study population: 15 boys with ASD (8-12 years old) will receive Memantine XR®.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Memantine-XR
- Keywords
- autism spectrum disorders, memantine, cortical metrics, sensory testing
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memantine-XRDrug
Also called Namenda-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.
| Study group | Role | What they receive |
|---|---|---|
| Memantine-XR | Boys ages 8-12 with ASD treated with Memantine-XR daily for 8 weeks Receives: Drug: Memantine-XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
cortical metrics (a mathematical plot of tactile responsivity in 3 dimensions)
a mathematical plot of tactile responsivity in 3 dimensions
Measured: 8 weeks
Secondary outcomes (3)
Clinical Global Impressions - Improvement Score.
ratings of 1 or 2 indicate clinically meaningful response
Measured: 8 weeks
PDD-BI SV change 0-8
18 item caregiver completed questionnaire about social functioning
Measured: 8 weeks
ABC-SW subscale score 0-8
13 item caregiver completed questionnaire about social problems
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Protocol did not continue once Investigator relocated to another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linmarie Sikich, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353130
- Sponsor's protocol ID
- 14-1996
- Status last verified
- Oct 2015
- First submitted
- 27 Jan 2015
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36006807
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development Of Cortical Metrics Assessment Outcome Measures in Response to Memantine Treatment in Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02353130
- Acronym / sponsor ID
- 14-1996
- Conditions
- Autism Spectrum Disorders
- Keywords
- autism spectrum disorders, memantine, cortical metrics, sensory testing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Protocol did not continue once Investigator relocated to another institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memantine-XR | – | Drug: Memantine-XRBoys ages 8-12 with ASD treated with Memantine-XR daily for 8 weeks |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 15 boys with ASD (8-12 years old) will receive Memantine XR®.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memantine-XRAlso: Namenda-XRParticipants 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. | Drug | Memantine-XR |
Primary outcome
cortical metrics (a mathematical plot of tactile responsivity in 3 dimensions)
Time frame: 8 weeks
a mathematical plot of tactile responsivity in 3 dimensions
3 secondary outcomes
Clinical Global Impressions - Improvement Score.
Time frame: 8 weeks
PDD-BI SV change 0-8
Time frame: 8 weeks
ABC-SW subscale score 0-8
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Derived from this study: PubMed 36006807Brignell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linmarie Sikich, MD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorders, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cortical metrics (a mathematical plot of tactile responsivity in 3 dimensions) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02353130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.