An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
|ClinicalTrials.gov Identifier: NCT01592786|
Recruitment Status : Completed
First Posted : May 7, 2012
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder (ASD) Autism Autistic Disorder Asperger's Disorder Asperger's Pediatric Autism Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)||Drug: Memantine Hydrochloride (HCl)||Phase 2|
This 50-week multicenter and multinational clinical study is comprised of a 2-week screening period, a 6-week open-label dose-titration period followed by a variable duration maintenance period (up to 42 weeks).
Patients with at least 12 weeks of investigational product exposure who meet the protocol specified responder criterion at two consecutive visits separated by at least two weeks are eligible to transition to a randomized withdrawal study. A responder is defined as a patient who demonstrates at least a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score.
Weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a 10-fold lower exposure than observed at the No observed adverse effect level (NOAEL) of 15 mg/kg/day in juvenile rats.
The weight-based dose limits in this study were as follows:
- Group A: ≥ 60 kg; maximum 15 mg/day
- Group B: 40-59 kg; maximum 9 mg/day
- Group C: 20-39 kg; maximum 6 mg/day
- Group D: < 20 kg; maximum 3 mg/day
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||906 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label 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)|
|Study Start Date :||June 2012|
|Primary Completion Date :||July 2013|
|Study Completion Date :||August 2013|
Experimental: Memantine Hydrochloride (HCl)
Once daily oral administration of open-label memantine for up to 48 weeks: 6-week dose-titration period followed by up to 42-week maintenance period.
Drug: Memantine Hydrochloride (HCl)
Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.
Other Name: Namenda
- Number of Confirmed Social Responsiveness Scale (SRS) Responders [ Time Frame: Visit 1 (Baseline) to Visit 8 (week 48/Final Visit) ]
A confirmed SRS responder was defined as a patient who had at least 12 weeks of exposure to memantine, and a ≥ 10-point reduction in the SRS total raw score relative to baseline at 2 consecutive visits separated by at least 2 weeks.
The SRS is a 65-item, caregiver-rated assessment scale that measures observable items on social behavior and social language use, as well as characteristics of autism in a naturalistic social setting. Each item is rated on a scale from 0 (never true) to 3 (almost always true). The SRS total raw score ranges from 0 to 195; a higher score indicates greater severity of social impairment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592786
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|Study Director:||Jordan Lateiner, MS, MBA||Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.|