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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01592773
First received: May 3, 2012
Last updated: June 5, 2014
Last verified: June 2014

May 3, 2012
June 5, 2014
September 2012
January 2014   (final data collection date for primary outcome measure)
Safety [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Adverse event (AE) recording, clinical laboratory measures, vital signs parameters, electrocardiograms (ECGs), cognitive testing, suicidality, and physical examinations
Same as current
Complete list of historical versions of study NCT01592773 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
An Open-Label Extension 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)

The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

This clinical study will be a 48-week, multicenter, open-label extension study in pediatric outpatients with autism, Asperger's Disorder, or PDD-NOS conducted at approximately 180 study centers. Patients may be eligible for this long-term extension study if they have:

  • completed the open-label Study MEM MD 67,
  • completed the open-label Study MEM-MD-91,
  • completed the double-blind study MEM-MD-68,
  • discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Autism Spectrum Disorder (ASD)
  • Autism
  • Autistic Disorder
  • Asperger's Disorder
  • Asperger's
  • Pediatric Autism
  • Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
  • Pervasive Child Development Disorder
Drug: Memantine Hydrochloride (HCl)

During double-blind treatment Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing will be once daily.

During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage will be that identified during the prior studies for each patient. Dosing will be once daily.

Other Name: Namenda
Experimental: Memantine

To maintain the blind of the preceding study, patients who participated in MEM-MD-68 will begin this study with 6 weeks of double blind dosing during which all patients will either be titrated to or remain on their maximum target dosages. Patients who have had a break of > 3days since last treatment will be titrated. This will be followed by 42 weeks of open-label dosing.

Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM MD 91, will receive 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.

Intervention: Drug: Memantine Hydrochloride (HCl)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
748
April 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who completed Study MEM-MD-67, MEM-MD-68 or MEM-MD-91.
  • Patients who discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.

Exclusion Criteria:

  • Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Colombia,   Estonia,   France,   Hungary,   Iceland,   Italy,   Korea, Republic of,   New Zealand,   Poland,   Serbia,   South Africa,   Spain,   Ukraine
 
NCT01592773
MEM-MD-69
No
Forest Laboratories
Forest Laboratories
Not Provided
Study Director: Jordan Lateiner, MS, MBA Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.
Forest Laboratories
June 2014

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