Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
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|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|
|Actual Primary Completion Date :||January 2014|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592773
|Study Director:||Jordan Lateiner, MS, MBA||Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.|