Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01592786 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
A Phase 2 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 906
- Enrollment target
NCT01592786: Completed Phase 2 study, sponsored by Forest Laboratories.
NCT01592786 is a Phase 2 study that has completed, run by Forest Laboratories. The registered enrollment target is 906 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (581% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01592786, a Phase 2 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 906 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.
Primary Outcome
A confirmed SRS responder was defined as a patient who had at least 12 weeks of exposure to memantine, and a ≥ 10-point reduction in the SRS total raw score relative to baseline at 2 consecutive visits separated by at least 2 weeks. The SRS is a 65-item, caregiver-rated assessment scale that measures observable items on social behavior and social language use, as well as characteristics of autism in a naturalistic social setting. Each item is rated on a scale from 0 (never true) to 3 (almost al
Interventions
- DRUG Memantine Hydrochloride (HCl)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 906 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT01592786 record still lists
NCT01592786 is an interventional study that assigns participants to a tested intervention. The registered 906 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (581% higher).
The record links to 0 conditions, and to 1 intervention - of which Memantine Hydrochloride (HCl) is the first listed.
NCT01592786 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01592786 about?
NCT01592786 is a clinical study titled "An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)". The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized with...
What is the current status of trial NCT01592786?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 906 participants. The study started on 2012-06. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01592786?
The interventions under investigation include: Memantine Hydrochloride (HCl) (DRUG).
Who is sponsoring clinical trial NCT01592786?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01592786's enrollment target sits among peer trials
906 30th of 2000 higher than 1,971 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05658497 · 908 participants
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
- NCT06216548 · 909 participants · NA
E-PRIME For Children With Medical Complexity
- NCT05769777 · 901 participants · Phase 2
Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
- NCT02352116 · 900 participants · NA
Evaluation of Post-PACU Pain Management in Pediatric Surgery
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia