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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 terminated.
(Terminated because primary efficacy parameter failed to demonstrate statistically significant difference between memantine and placebo in controlled trials)
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01592773
First received: May 3, 2012
Last updated: January 30, 2015
Last verified: January 2015

May 3, 2012
January 30, 2015
October 2012
January 2014   (final data collection date for primary outcome measure)
Patients With Any Treatment-emergent Adverse Event [ Time Frame: Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit ] [ Designated as safety issue: Yes ]
Number of patients who experienced 1 or more Treatment Emergent Adverse Event
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
Complete list of historical versions of study NCT01592773 on ClinicalTrials.gov Archive Site
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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)
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 was a 48-week, multicenter, multinational, open-label extension study in pediatric outpatients with autism, Asperger's Disorder, or PDD-NOS conducted at 106 study centers. Patients were eligible for this long-term extension study if they had:

  • completed the open-label Study MEM MD 67,or
  • completed the open-label Study MEM-MD-91, or
  • completed the double-blind Study MEM-MD-68, or
  • discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response

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

The decision to close the study early was based on data from 2 double-blind placebo-controlled studies (MEM-MD-57A and MEM-MD-68) that failed to demonstrate a statistically significant difference between memantine and placebo in the primary efficacy parameter based on Social Responsiveness Scale (SRS) total raw score.

Interventional
Phase 2
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)
Drug: Memantine Hydrochloride (HCl)

During the 6-week double-blind dosing titration/maintenance period, Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing was once daily.

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

Other Name: Namenda
Experimental: Memantine

To maintain the blind of the preceding study, patients who participated in MEM-MD-68 (NCT01592747) began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.

Patients who took open-label memantine in study MEM-MD-67 (NCT01999894) or MEM-MD-91(NCT01592786), received up to 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.
 
Terminated
747
March 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who completed Study MEM-MD-67, MEM-MD-68, MEM-MD-91, or discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.
  • Having normal results from a physical examination and laboratory tests at Visit 1 of this study (last visit of the preceding study). Any abnormal findings must be deemed not clinically significant by the Investigator and documented as such.
  • 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:

  • Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug
  • Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being
  • Significant risk of suicidality based on the Investigator's judgment, Aberrant Behavior Checklist-irritability subscale (ABC-I), or if appropriate, as indicated by a response of "yes" to questions 4 or 5 in the suicidal ideation section of the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior
Both
6 Years to 12 Years   (Child)
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
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Forest Laboratories
Forest Laboratories
Not Provided
Study Director: Jordan Lateiner, MS, MBA Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.
Forest Laboratories
January 2015

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