Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism - NCT00872898-33432(Clinical Trial 281395)
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| City: |
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Boca Raton |
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State:
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FL |
| Zip Code: |
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33432 |
| Conditions: |
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Autism |
| Purpose: |
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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.
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| Study summary: |
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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: |
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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 |
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| Study is available at: |
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Forest Investigative Site
Boca Raton, FL 33432
United States
Primary Contact:
Sandra Beaird, PhD
Email: info@forestpharm.com
Phone: 1-800-678-1605 |
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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.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
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above to view all information about this clinical trial. |
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