Status:
COMPLETED
Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Merz Pharmaceuticals GmbH
Conditions:
Autism
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.
Detailed Description
This is a multicenter, two-part study in pediatric (ages 6 to 18 years) patients diagnosed with autism. Patients participating in Part One will receive a single open-label dose of memantine. Blood sa...
Eligibility Criteria
Inclusion
- Males or females ages 6 to 12 years
- Diagnosis of autistic disorder, according to DSM-IV-TR using Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule (modules 2 \& 3).
- A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
- Patients over age 12, only if they completed Study MEM-PK-21
Exclusion
- Medical history of active epilepsy/seizure disorder except simple febrile seizures
- Participation in any other clinical investigation using an experimental drug within 30 days of the start of this study
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00872898
Start Date
April 1 2009
Last Update
January 14 2014
Active Locations (17)
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1
Forest Investigative Site
Phoenix, Arizona, United States, 85006
2
Forest Investigative Site
Sacramento, California, United States, 95817
3
Forest Investigative Site
San Francisco, California, United States, 94143
4
Forest Investigative Site
Santa Ana, California, United States, 92705