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Trial record 33 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01999894
Recruitment Status : Completed
First Posted : December 3, 2013
Results First Posted : March 18, 2014
Last Update Posted : March 18, 2014
Sponsor:
Collaborator:
Merz Pharmaceuticals GmbH
Information provided by (Responsible Party):
Forest Laboratories

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.

Condition or disease Intervention/treatment Phase
Autism Pediatric Autism Drug: Memantine HCl Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Memantine
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.
Other Names:
  • Namenda
  • Namenda XR




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999894


Locations
Show Show 19 study locations
Sponsors and Collaborators
Forest Laboratories
Merz Pharmaceuticals GmbH
Investigators
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Study Director: Ephraim Katz, PhD Forest Laboratories
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01999894    
Other Study ID Numbers: MEM-MD-67
First Posted: December 3, 2013    Key Record Dates
Results First Posted: March 18, 2014
Last Update Posted: March 18, 2014
Last Verified: January 2014
Keywords provided by Forest Laboratories:
Namenda
Autism
Memantine
Pediatric
Forest Laboratories
Additional relevant MeSH terms:
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Child Development Disorders, Pervasive
Autistic Disorder
Autism Spectrum Disorder
Neurodevelopmental Disorders
Mental Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents