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

Phase 2

Terminated

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

Brief Summary: 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).

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Memantine	Memantine Hydrochloride (HCl)	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.

Primary Outcome Measures

Name	Time	Method
Patients With Any Treatment-emergent Adverse Event	Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit	Number of patients who experienced 1 or more Treatment Emergent Adverse Event

Secondary Outcome Measures

Name	Time	Method

Locations (106): Forest Investigative Site 068
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Dothan, Alabama, United States
Forest Investigative Site 005
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
Forest Investigative Site 077
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Little Rock, Arkansas, United States
Forest Investigative Site 054
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Glendale, California, United States
Forest Investigative Site 109
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Imperial, California, United States
Forest Investigative Site 066
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Irvine, California, United States
Forest Investigative Site 096
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Los Angeles, California, United States
Forest Investigative Site 021
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San Francisco, California, United States
Forest Investigative Site 026
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Santa Ana, California, United States
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Forest Investigative Site 068
🇺🇸Dothan, Alabama, United States