- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01078844
Memantine in Adult Autism Spectrum Disorder
June 27, 2017 updated by: Johns Hopkins University
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).
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Bayview
-
-
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
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Treatment as usual plus placebo
|
Look-alike placebo
|
Active Comparator: memantine
Treatment as usual plus memantine
|
memantine 5-20 mg daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Global Impression-Scale(CGI-S)
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric Samstad, MD, Johns Hopkins University
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.
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 (Actual)
February 1, 2010
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
March 1, 2010
First Submitted That Met QC Criteria
March 1, 2010
First Posted (Estimate)
March 2, 2010
Study Record Updates
Last Update Posted (Actual)
July 26, 2017
Last Update Submitted That Met QC Criteria
June 27, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Neurodevelopmental Disorders
- Disease
- Autistic Disorder
- Autism Spectrum Disorder
- Child Development Disorders, Pervasive
- Developmental Disabilities
- Asperger Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- NA_00015760
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.
Clinical Trials on Autism
-
EarliTec Diagnostics, IncMarcus Autism CenterRecruitingAutism Spectrum Disorder | Developmental Delay | Autism | Autism, Early Infantile | Autism, InfantileUnited States
-
IRIS Media IncCompletedAutism DisorderUnited States
-
University of California, San FranciscoWithdrawn
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
Forest LaboratoriesMerz Pharmaceuticals GmbHCompletedAutism | Pediatric AutismUnited States
-
University of Medicine and Dentistry of New JerseyNational Alliance for Autism ResearchCompleted
-
General Administration of Military Health, TunisiaMilitary Hospital of TunisRecruiting
-
Assistance Publique - Hôpitaux de ParisUnknownAutism Spectrum Disorder | Child AutismFrance
-
The Hong Kong Polytechnic UniversityRecruitingAutism Spectrum Disorder | High-functioning AutismHong Kong
-
Emory UniversityNational Institute of Mental Health (NIMH)Terminated
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States