Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism - NCT00872898-08755(Clinical Trial 281400)
ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.
| City: |
|
Toms River |
|
State:
|
|
NJ |
| Zip Code: |
|
08755 |
| Conditions: |
|
Autism |
| Purpose: |
|
The purpose of this study is to investigate the safety and efficacy of memantine HCl, as
well as its extent of absorption in pediatric patients with autism.
|
| Study summary: |
|
This is a multicenter, two-part study in pediatric (ages 6 to 12 years) patients diagnosed
with autism.
Patients participating In Part One will receive a single open-label dose of memantine HCl.
Blood samples for pharmacokinetic analysis will be collected.
Part Two is a randomized, double-blind, placebo-controlled 12-week efficacy and safety study
evaluating change in all core domains (social interactions, communication, and restricted
interests and repetitive behaviors) of autism. |
| Criteria: |
|
Inclusion Criteria:
- Males or females ages 6 to 12 years
- Diagnosis of autistic disorder,
- A knowledgeable caregiver capable of providing reliable information about the
patient's condition, able to attend all clinic visits with the patient,
Exclusion Criteria:
- 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 |
|
|
|
| Study is available at: |
|
Forest Investigative Site
Toms River, NJ 08755
United States
Primary Contact:
Sandra Beaird, PhD
Email: info@forestpharm.com
Phone: 1-800-678-1605 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 23, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|