Autism Clinical Trial
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)
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05302167 -
Molehill Mountain Feasibility Study.
|
N/A | |
| Completed |
NCT04167839 -
Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement
|
N/A | |
| Terminated |
NCT04049981 -
Investigation of Mechanisms of Action in Superpower Glass
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT06080087 -
Implementation Toolkit to Enhance EBP Among Marginalized Families
|
N/A | |
| Recruiting |
NCT04107064 -
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
|
N/A | |
| Completed |
NCT03206996 -
Exposure Therapy for Auditory Sensitivity in Autism
|
N/A | |
| Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
| Completed |
NCT05588570 -
Coaching Children With Anxiety and Autism Through Telehealth
|
N/A | |
| Enrolling by invitation |
NCT06058104 -
Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism
|
N/A | |
| Withdrawn |
NCT02414451 -
Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response
|
N/A | |
| Completed |
NCT03002363 -
The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance
|
Phase 1 | |
| Completed |
NCT02847182 -
Cord Blood Infusion for Children With Autism Spectrum Disorder
|
Phase 2 | |
| Completed |
NCT02911194 -
a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)
|
N/A | |
| Completed |
NCT02536365 -
Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
|
N/A | |
| Completed |
NCT02720900 -
Prebiotic Intervention for Autism Spectrum Disorders
|
N/A | |
| Completed |
NCT02508922 -
Trial of Vitamin D3 Supplementation in Paediatric Autism
|
N/A | |
| Completed |
NCT02708290 -
Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
|
||
| Recruiting |
NCT01836562 -
A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02255565 -
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
|
Phase 4 | |
| Completed |
NCT02154828 -
Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)
|