Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
|ClinicalTrials.gov Identifier: NCT01592773|
Recruitment Status : Terminated (Terminated because primary efficacy parameter failed to demonstrate statistically significant difference between memantine and placebo in controlled trials)
First Posted : May 7, 2012
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|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)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||747 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2012|
|Primary Completion Date :||January 2014|
|Study Completion Date :||March 2014|
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.
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
- 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 ]Number of patients who experienced 1 or more Treatment Emergent Adverse Event
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592773
Show 106 Study Locations
|Study Director:||Jordan Lateiner, MS, MBA||Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.|