Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Neurology, Neurology, Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | September 2012 |
| End Date: | August 2014 |
| Contact: | Sandra Beaird |
| Email: | info@forestpharm.com |
| Phone: | 1-800-678-1605 |
An Open-Label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
The objective of this study is to evaluate the long-term safety and tolerability of
memantine in the treatment of pediatric patients with autism, Asperger's Disorder or
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
This clinical study will be a 48-week, multicenter, open-label extension study in pediatric
outpatients with autism, Asperger's Disorder, or PDD-NOS conducted at approximately 180
study centers. Patients may be eligible for this long-term extension study if they have:
- completed the open-label Study MEM MD 67,
- completed the open-label Study MEM-MD-91,
- completed the double-blind study MEM-MD-68,
- discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response
Inclusion Criteria:
- Patients who completed Study MEM-MD-67, MEM-MD-68 or MEM-MD-91.
- Patients who discontinued Study MEM-MD-68 due to meeting the criterion for loss of
therapeutic response.
Exclusion Criteria:
- Patients who discontinued a preceding memantine study due to an adverse event
possibly related to study drug
We found this trial at
87
sites
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