|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Forest Laboratories Merz Pharmaceuticals GmbH |
|---|---|
| Information provided by: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT00872898 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Autism |
Drug: Memantine-HCl Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | An Open-Label (Part One) and a Randomized, Double-Blind, Placebo-Controlled (Part Two) Study of the Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Pediatric Patients With Autism |
| Estimated Enrollment: | 96 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Once daily oral administration of memantine for 12 weeks.
|
Drug: Memantine-HCl
Memantine - 3mg and 6mg capsules at a dosage of 3, 6, 9, 12, or 18 mg/d (depending on weight) administered orally.
|
|
2: Placebo Comparator
Once daily oral administration of placebo for 12 weeks.
|
Drug: Placebo
Placebo capsules, once daily, oral administration.
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sandra Beaird, PhD | 1-800-678-1605 | info@forestpharm.com |
| United States, Arizona | |
| Forest Investigative Site | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Forest Investigative Site | Not yet recruiting |
| Stanford, California, United States, 94305 | |
| Forest Investigative Site | Not yet recruiting |
| Sacramento, California, United States, 95817 | |
| United States, Florida | |
| Forest Investigative Site | Not yet recruiting |
| St Petersburg, Florida, United States, 33701 | |
| United States, Illinois | |
| Forest Investigative Site | Not yet recruiting |
| Chicago, Illinois, United States, 60608 | |
| Forest Investigative Site | Recruiting |
| Hoffman Estates, Illinois, United States, 60169 | |
| United States, Indiana | |
| Forest Investigative Site | Not yet recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| United States, New Jersey | |
| Forest Investigative Site | Recruiting |
| Voorhees, New Jersey, United States, 08043 | |
| Forest Investigative Site | Recruiting |
| Toms River, New Jersey, United States, 08755 | |
| United States, New York | |
| Forest Investigative Site | Not yet recruiting |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| Forest Investigative Site | Not yet recruiting |
| Columbus, Ohio, United States, 43210 | |
| Forest Investigative Site | Not yet recruiting |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Forest Investigative Site | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15203 | |
| United States, Texas | |
| Forest Investigative Site | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Study Director: | Ephraim Katz, PhD | Forest Research Institute, a subsidiary of Forest Laboratories, Inc. |
More Information
| Responsible Party: | Forest Research Institute, a subsidiary of Forest Laboratories, Inc. ( James Perhach, PhD, Executive Director, Clinical Development, Neurology ) |
| Study ID Numbers: | MEM-MD-57A |
| Study First Received: | March 30, 2009 |
| Last Updated: | April 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00872898 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
autism memantine pediatric Forest Laboratories Autism in pediatric patients |
|
Child Development Disorders, Pervasive Developmental Disabilities Excitatory Amino Acids Neurotransmitter Agents Dopamine Mental Disorders |
Autistic Disorder Mental Disorders Diagnosed in Childhood Memantine Dopamine Agents Autism |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Antiparkinson Agents Excitatory Amino Acid Agents Pharmacologic Actions Child Development Disorders, Pervasive |
Autistic Disorder Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Memantine Dopamine Agents Central Nervous System Agents Excitatory Amino Acid Antagonists |
