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

Condition(s) targeted: Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pediatric Autism; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Intervention: Memantine Hydrochloride (HCl) (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Jordan Lateiner, MS, MBA, Study Director, Affiliation: Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.

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).

Official title: 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)

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Patients With Any Treatment-emergent Adverse Event

Detailed description: 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.

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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

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Starting date: October 2012
Last updated: January 30, 2015