Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism

NCT ID: NCT00872898

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30

Brief Summary

The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.

Detailed Description

This is a multicenter, two-part study in pediatric (ages 6 to 18 years) patients diagnosed with autism.

Patients participating in Part One will receive a single open-label dose of memantine. Blood samples for pharmacokinetic analysis will be collected.

Part Two is a randomized, double-blind, placebo-controlled 12-week efficacy and safety study evaluating change in all core domains (social interactions, communication, and restricted interests and repetitive behaviors) of autism.

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

Conditions

Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Once daily oral administration of memantine for 12 weeks.

Group Type: EXPERIMENTAL

Memantine - Extended Release (ER)

Intervention Type: DRUG

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

2

Once daily oral administration of placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsules, once daily, oral administration.

Interventions

Memantine - Extended Release (ER)

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Intervention Type: DRUG

Placebo

Placebo capsules, once daily, oral administration.

Intervention Type: DRUG

Other Intervention Names

Namenda ER

Eligibility Criteria

Inclusion Criteria

• Males or females ages 6 to 12 years
• Diagnosis of autistic disorder, according to DSM-IV-TR using Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule (modules 2 & 3).
• A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
• Patients over age 12, only if they completed Study MEM-PK-21

Exclusion Criteria

• Medical history of active epilepsy/seizure disorder except simple febrile seizures
• Participation in any other clinical investigation using an experimental drug within 30 days of the start of this study

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role: collaborator

Forest Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ephraim Katz, PhD

Role: STUDY_DIRECTOR

Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

Locations

Forest Investigative Site

Phoenix, Arizona, United States

Forest Investigative Site

Sacramento, California, United States

Forest Investigative Site

San Francisco, California, United States

Forest Investigative Site

Santa Ana, California, United States

Forest Investigative Site

Stanford, California, United States

Forest Investigative Site

Jacksonville Beach, Florida, United States

Forest Investigative Site

St. Petersburg, Florida, United States

Forest Investigative Site

Hoffman Estates, Illinois, United States

Forest Investigative site

Naperville, Illinois, United States

Forest Investigative Site

Indianapolis, Indiana, United States

Forest Investigative Site

Cambridge, Massachusetts, United States

Forest Investigative Site

Toms River, New Jersey, United States

Forest Investigative Site

Voorhees Township, New Jersey, United States

Forest Investigative Site

Manhasset, New York, United States

Forest Investigative Site

Cleveland, Ohio, United States

Forest Investigative Site

Columbus, Ohio, United States

Forest Investigative Site

Oklahoma City, Oklahoma, United States

Countries

United States

References

Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

Reference Type: DERIVED

PMID: 37811711 (View on PubMed)

Brignell A, Marraffa C, Williams K, May T. Memantine for autism spectrum disorder. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013845. doi: 10.1002/14651858.CD013845.pub2.

Reference Type: DERIVED

PMID: 36006807 (View on PubMed)

Other Identifiers

MEM-MD-57A

Identifier Type: -

Identifier Source: org_study_id