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NCT00913614 · ClinicalTrials.gov registry record · Phase 1
Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT00913614: Completed Phase 1 study, sponsored by Sanofi.
NCT00913614 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00913614, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
Given the potential age-related differences in safety, tolerability, pharmacokinetics, and differences in sleep architecture in young children versus adolescent versus adult, studies to identify the appropriate drug and dosage for children of all ages are essential in addressing this health problem that impacts the child and their family. The objective of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of eplivanserin. Primary objective: to assess the safety and tolerability after administration of single ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various origins. To assess the pharmacokinetics of eplivanserin (and active metabolite: SR141342) after administration of single ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various origins. Secondary objective: to assess the effect of single ascending oral doses of eplivanserin on global sleep parameters and sleep architecture measured via polysomnography recordings in children aged 6-17 years old with insomnia of various origins.
Interventions
- DRUG Eplivanserin (SR46349)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2009-06 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
What the finished NCT00913614 record still lists
NCT00913614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 1 intervention - of which Eplivanserin (SR46349) is the first listed.
NCT00913614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00913614 about?
NCT00913614 is a clinical study titled "Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia". Given the potential age-related differences in safety, tolerability, pharmacokinetics, and differences in sleep architecture in young children versus adolescent versus adult, studies to identify the appropriate drug and dosage for children of all ages are essential in addressing this health problem ...
What is the current status of trial NCT00913614?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2009-06. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00913614?
The interventions under investigation include: Eplivanserin (SR46349) (DRUG).
Who is sponsoring clinical trial NCT00913614?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00913614's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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