Open-label Study of Safety and Tolerability of Memantine in Children With Autism
|ClinicalTrials.gov Identifier: NCT01999894|
Recruitment Status : Completed
First Posted : December 3, 2013
Results First Posted : March 18, 2014
Last Update Posted : March 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Autism Pediatric Autism||Drug: Memantine HCl||Phase 2|
This is a 48-week multicenter extension study comprised of a 6-week double-blind dose-titration period followed by a 42-week open-label maintenance period.
In the Forest autism trials conducted in children ages 6-12, dosing with an extended release formulation of memantine was weight-based. These weight based dose limits were selected to ensure exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng∙h/mL that represented a 10-fold lower exposure than observed at the NOAEL (No observed adverse effect level) of 15 mg/kg/day in juvenile rats.
The weight-based dose limits in these studies were as follows:
- Group A: ≥ 60 kg; max 15 mg/day
- Group B: 40-59 kg; max 9 mg/day
- Group C: 20-39 kg; max 6 mg/day
- Group D: < 20 kg; max 3 mg/day
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Once daily oral administration of memantine for 48 weeks: 6-week double-blind dose-titration period followed by a 42-week maintenance period.
Drug: Memantine HCl
Memantine extended release 3- and 6-mg capsules; dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for 48 weeks.
- Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE) [ Time Frame: From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48) ]Number of patients who experienced one or more TEAEs during the study
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999894
|Study Director:||Ephraim Katz, PhD||Forest Laboratories|