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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 is a Phase 3 study that has completed, run by Neurim Pharmaceuticals. The registered enrollment target is 125 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01906866
The ClinicalTrials.gov registry entry for NCT01906866 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurim Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01906866 reports 0 study locations.
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.
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