Memantine in Adult Autism Spectrum Disorder

Autism Clinical Trial

Official title:

Memantine in Adult Autism Spectrum Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01078844
• Other study ID #: NAM_MD_69
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 1, 2010
• Last updated: March 1, 2010
• Start date: October 2009
• Est. completion date: April 2011

Study information

• Verified date: March 2010
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 NOS.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion criteria

• Participant is currently in treatment in the JHBMC ASNC

• Participant has a diagnosis of:

• Autistic Disorder

• Asperger's 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

• GFR < 30 mL/min

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asperger Syndrome
• Asperger's Disorder
• Autism
• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities
• Disease
• Pervasive Developmental Disorder NOS

Intervention

Drug:
• memantine
memantine 5-20 mg daily
• Placebo
Look-alike placebo

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression-Scale(CGI-S)		12 weeks	No