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Memantine in Adult Autism Spectrum Disorder

Primary Purpose

Autism, Asperger's Disorder, Pervasive Developmental Disorder NOS

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
memantine
Placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, Asperger's Disorder, Pervasive Developmental Disorder NOS, Adult, Memantine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Participant is currently in treatment in the Johns Hopkins Bayview Medical Center (JHBMC)

  • Participant has a diagnosis of:

    • Autistic Disorder
    • Asperger's Disorder
    • Pervasive Developmental Disorder (PDD) NOS

  • Participant meets one of the following criteria:

    • CGI-S >= 4 (CGI-S: ________)

    • Participant has the following problematic behaviors (at least one) that might be expected to benefit from memantine:

      1. _____________________________________________
      2. _____________________________________________
      3. _____________________________________________

Exclusion criteria

The patient meets none of the following criteria (mark if absent):

  • Active seizures (Patients with a history of seizures, who have been seizure-free on an antiepileptic regimen for six months or more would be eligible).
  • Rett's Syndrome or Childhood Disintegrative Disorder
  • Active treatment with an acetylcholinesterase inhibitor
  • Prior or current treatment with memantine
  • Current treatment with lamotrigine
  • Genetic, metabolic or degenerative disorder (excepting Fragile X).
  • Brain malformation or known severe brain trauma
  • Pregnancy or breastfeeding
  • Glomerular Filtration Rate (GFR) < 30 mL/min

Sites / Locations

  • Johns Hopkins Bayview

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

memantine

Arm Description

Treatment as usual plus placebo

Treatment as usual plus memantine

Outcomes

Primary Outcome Measures

Clinical Global Impression-Scale(CGI-S)

Secondary Outcome Measures

Full Information

First Posted
March 1, 2010
Last Updated
June 27, 2017
Sponsor
Johns Hopkins University
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01078844
Brief Title
Memantine in Adult Autism Spectrum Disorder
Official Title
Memantine in Adult Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor withdrew funds
Study Start Date
February 2010 (Actual)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Asperger's Disorder, Pervasive Developmental Disorder NOS
Keywords
Autism, Asperger's Disorder, Pervasive Developmental Disorder NOS, Adult, Memantine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment as usual plus placebo
Arm Title
memantine
Arm Type
Active Comparator
Arm Description
Treatment as usual plus memantine
Intervention Type
Drug
Intervention Name(s)
memantine
Intervention Description
memantine 5-20 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Look-alike placebo
Primary Outcome Measure Information:
Title
Clinical Global Impression-Scale(CGI-S)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Participant is currently in treatment in the Johns Hopkins Bayview Medical Center (JHBMC) Participant has a diagnosis of: Autistic Disorder Asperger's Disorder Pervasive Developmental Disorder (PDD) NOS Participant meets one of the following criteria: CGI-S >= 4 (CGI-S: ________) Participant has the following problematic behaviors (at least one) that might be expected to benefit from memantine: _____________________________________________ _____________________________________________ _____________________________________________ Exclusion criteria The patient meets none of the following criteria (mark if absent): Active seizures (Patients with a history of seizures, who have been seizure-free on an antiepileptic regimen for six months or more would be eligible). Rett's Syndrome or Childhood Disintegrative Disorder Active treatment with an acetylcholinesterase inhibitor Prior or current treatment with memantine Current treatment with lamotrigine Genetic, metabolic or degenerative disorder (excepting Fragile X). Brain malformation or known severe brain trauma Pregnancy or breastfeeding Glomerular Filtration Rate (GFR) < 30 mL/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Samstad, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36006807
Citation
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.
Results Reference
derived

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Memantine in Adult Autism Spectrum Disorder

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