Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 24 for:    Developmental Disabilities | ( Map: South Carolina, United States )

An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

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: NCT01592786
Recruitment Status : Completed
First Posted : May 7, 2012
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE May 3, 2012
First Posted Date  ICMJE May 7, 2012
Results First Submitted Date  ICMJE July 15, 2014
Results First Posted Date  ICMJE August 7, 2014
Last Update Posted Date August 7, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
Number of Confirmed Social Responsiveness Scale (SRS) Responders [ Time Frame: Visit 1 (Baseline) to Visit 8 (week 48/Final Visit) ]
A confirmed SRS responder was defined as a patient who had at least 12 weeks of exposure to memantine, and a ≥ 10-point reduction in the SRS total raw score relative to baseline at 2 consecutive visits separated by at least 2 weeks. The SRS is a 65-item, caregiver-rated assessment scale that measures observable items on social behavior and social language use, as well as characteristics of autism in a naturalistic social setting. Each item is rated on a scale from 0 (never true) to 3 (almost always true). The SRS total raw score ranges from 0 to 195; a higher score indicates greater severity of social impairment.
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2012)
Safety [ Time Frame: 50 weeks ]
Adverse event (AE) monitoring, clinical laboratory measures, vital sign parameters, electrocardiograms (ECGs), suicidality, and physical examinations.
Change History Complete list of historical versions of study NCT01592786 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Official Title  ICMJE An Open-Label Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Brief Summary The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.
Detailed Description

This 50-week multicenter and multinational clinical study is comprised of a 2-week screening period, a 6-week open-label dose-titration period followed by a variable duration maintenance period (up to 42 weeks).

Patients with at least 12 weeks of investigational product exposure who meet the protocol specified responder criterion at two consecutive visits separated by at least two weeks are eligible to transition to a randomized withdrawal study. A responder is defined as a patient who demonstrates at least a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score.

Weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a 10-fold lower exposure than observed at the No observed adverse effect level (NOAEL) of 15 mg/kg/day in juvenile rats.

The weight-based dose limits in this study were as follows:

  • Group A: ≥ 60 kg; maximum 15 mg/day
  • Group B: 40-59 kg; maximum 9 mg/day
  • Group C: 20-39 kg; maximum 6 mg/day
  • Group D: < 20 kg; maximum 3 mg/day
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism Spectrum Disorder (ASD)
  • Autism
  • Autistic Disorder
  • Asperger's Disorder
  • Asperger's
  • Pediatric Autism
  • Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Intervention  ICMJE Drug: Memantine Hydrochloride (HCl)
Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.
Other Name: Namenda
Study Arms  ICMJE Experimental: Memantine Hydrochloride (HCl)
Once daily oral administration of open-label memantine for up to 48 weeks: 6-week dose-titration period followed by up to 42-week maintenance period.
Intervention: Drug: Memantine Hydrochloride (HCl)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2013)
906
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2012)
192
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female outpatients.
  2. Age of 6-12.
  3. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
  4. Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study

Exclusion Criteria:

  1. Have enrolled in Study MEM-MD-57A
  2. Medical conditions that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well-being.
  3. Participation in any other clinical investigation using an experimental drug within 30 days of screening.
  4. Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's Disorder, and PDD-NOS.
  5. Meeting DSM-IV-TR criteria for bipolar I disorder, psychotic disorder not otherwise specified, posttraumatic stress disorder, schizophrenia, or major depressive disorder within the past 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States,   Australia,   Belgium,   Canada,   Colombia,   Estonia,   France,   Hungary,   Iceland,   Italy,   Korea, Republic of,   New Zealand,   Poland,   Serbia,   Singapore,   South Africa,   Spain,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01592786
Other Study ID Numbers  ICMJE MEM-MD-91
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Forest Laboratories
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jordan Lateiner, MS, MBA Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.
PRS Account Forest Laboratories
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP