Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Autism Spectrum Disorder (ASD) Autism Autistic Disorder Asperger's Disorder Asperger's Pediatric Autism Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Pervasive Child Development Disorder |
Drug: Memantine Hydrochloride (HCl) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
- Safety [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]Adverse event (AE) recording, clinical laboratory measures, vital signs parameters, electrocardiograms (ECGs), cognitive testing, suicidality, and physical examinations
| Estimated Enrollment: | 220 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Memantine
To maintain the blind of the preceding study, patients who participated in MEM-MD-68 will begin this study with 6 weeks of double blind dosing during which all patients will either be titrated to or remain on their maximum target dosages. Patients who have had a break of > 3days since last treatment will be titrated. This will be followed by 42 weeks of open-label dosing. Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM MD 91, will receive 48 weeks of open-label memantine at their maximum tolerated weight based target dosage. |
Drug: Memantine Hydrochloride (HCl)
During double-blind treatment Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing will be once daily. During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage will be that identified during the prior studies for each patient. Dosing will be once daily. Other Name: Namenda
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 123 Study Locations| Study Director: | Jordan Lateiner, MS, MBA | Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc. |
More Information
No publications provided
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01592773 History of Changes |
| Other Study ID Numbers: | MEM-MD-69 |
| Study First Received: | May 3, 2012 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Canada: Public Health Agency of Canada Estonia: The State Agency of Medicine Italy: Ethics Committee New Zealand: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products South Africa: Medicines Control Council South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Forest Laboratories:
|
Autistic Disorder Asperger's Disorder Asperger's |
Pediatric Autism Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Pervasive Child Development Disorder |
Additional relevant MeSH terms:
|
Child Development Disorders, Pervasive Autistic Disorder Developmental Disabilities Asperger Syndrome Mental Disorders Diagnosed in Childhood Mental Disorders Memantine Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013