Open-label Study of Safety and Tolerability of Memantine in Children With Autism

Autism Clinical Trial

Official title:

An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999894
• Other study ID #: MEM-MD-67
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2013
• Last updated: January 31, 2014
• Start date: November 2009
• Est. completion date: February 2013

Study information

• Verified date: January 2014
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Completed lead-in study MEM-MD-57A (NCT00872898)

• A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient

Exclusion Criteria:

• Patients with a concurrent medical condition that might interfere with the conduct of the study

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Pediatric Autism

Intervention

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.

Locations

Country	Name	City	State
United States	Forest Investigative Site 025	Cambridge	Massachusetts
United States	Forest Investigative Site 013	Cleveland	Ohio
United States	Forest Investigative Site 015	Cleveland	Ohio
United States	Forest Investigative Site 001	Columbus	Ohio
United States	Forest Investigative Site 014	Hoffman Estates	Illinois
United States	Forest Investigative Site 010	Indianapolis	Indiana
United States	Forest Investigative Site 024	Jacksonville Beach	Florida
United States	Forest Investigative Site 017	Manhasset	New York
United States	Forest Investigative Site 023	Naperville	Illinois
United States	Forest Investigative Site 019	Oklahoma	Oklahoma
United States	Forest Investigative Site 005	Phoenix	Arizona
United States	Forest Investigative Site 003	Sacramento	California
United States	Forest Investigative Site 021	San Francisco	California
United States	Forest Investigative Site 020	Santa Ana	California
United States	Forest Investigative Site 026	Santa Ana	California
United States	Forest Investigative Site 007	St. Petersburg	Florida
United States	Forest Investigative Site 002	Stanford	California
United States	Forest Investigative Site 011	Toms River	New Jersey
United States	Forest Investigative Site 006	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)	Number of patients who experienced one or more TEAEs during the study	From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)	Yes