Clinical trial NCT01999894: Open-label Study of Safety and Tolerability of Memantine in Children With Autism
Official title: An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism
Pediatric Autism
Keywords: Namenda
Autism
Memantine
Pediatric
Forest Laboratories
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Merz Pharmaceuticals GmbH
First posted: 2013-12-03
Enrollment: 102
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)
timeFrame: From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Forest Investigative Site 005
state: Arizona
city: Sacramento
country: United States
facility: Forest Investigative Site 003
state: California
city: San Francisco
country: United States
facility: Forest Investigative Site 021
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 026
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 020
state: California
city: Stanford
country: United States
facility: Forest Investigative Site 002
state: California
city: Jacksonville Beach
country: United States
facility: Forest Investigative Site 024
state: Florida
city: St. Petersburg
country: United States
facility: Forest Investigative Site 007
state: Florida
city: Hoffman Estates
country: United States
facility: Forest Investigative Site 014
state: Illinois
city: Naperville
country: United States
facility: Forest Investigative Site 023
state: Illinois
city: Indianapolis
country: United States
facility: Forest Investigative Site 010
state: Indiana
city: Cambridge
country: United States
facility: Forest Investigative Site 025
state: Massachusetts
city: Toms River
country: United States
facility: Forest Investigative Site 011
state: New Jersey
city: Voorhees
country: United States
facility: Forest Investigative Site 006
state: New Jersey
city: Manhasset
country: United States
facility: Forest Investigative Site 017
state: New York
city: Cleveland
country: United States
facility: Forest Investigative Site 013
state: Ohio
city: Cleveland
country: United States
facility: Forest Investigative Site 015
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 001
state: Ohio
city: Oklahoma
country: United States
facility: Forest Investigative Site 019
state: Oklahoma
Study officials:
affiliation: Forest Laboratories
name: Ephraim Katz, PhD
role: STUDY_DIRECTOR
References: