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NCT01906866 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
A Phase 3 study, sponsored by Neurim Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 125
- Enrollment target
NCT01906866: Completed Phase 3 study, sponsored by Neurim Pharmaceuticals.
NCT01906866 is a Phase 3 study that has completed, run by Neurim Pharmaceuticals. The registered enrollment target is 125 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01906866, a Phase 3 study, has completed, sponsored by Neurim Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 125 participants
- Enrollment target
Study Summary
The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and additional parameters in children with neurodevelopmental disabilities. The efficacy and safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period of 13 weeks.
Primary Outcome
The treatment effect of Circadin® 2/5 mg minitabs was compared to that of a placebo on total sleep time, as assessed by the Sleep and Nap Diary questionnaire, following 13 weeks of double-blind treatment
Interventions
- DRUG Placebo
- DRUG Circadin 2/5/10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2013-10 |
| Est. Completion | 2018-03-27 |
| Phase | Phase 3 |
What the finished NCT01906866 record still lists
NCT01906866 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01906866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01906866 about?
NCT01906866 is a clinical study titled "Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities". The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week treatment period with Circadin 2/5mg in impr...
What is the current status of trial NCT01906866?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2013-10. Estimated completion is 2018-03-27.
What interventions are being tested in trial NCT01906866?
The interventions under investigation include: Placebo (DRUG), Circadin 2/5/10 mg (DRUG).
Who is sponsoring clinical trial NCT01906866?
This trial is sponsored by Neurim Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01906866's enrollment target sits among peer trials
125 1605th of 2000 higher than 391 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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