# Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia

> **NCT00913614** · PHASE1 · COMPLETED · sponsor: **Sanofi** · enrollment: 41 (actual)

## Conditions studied

- Sleep Initiation and Maintenance Disorders

## Interventions

- **DRUG:** Eplivanserin (SR46349)

## Key facts

- **NCT ID:** NCT00913614
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-06
- **Primary completion:** 2009-12
- **Final completion:** 2009-12
- **Target enrollment:** 41 (ACTUAL)
- **Last updated:** 2010-11-30


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00913614

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00913614, "Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia". Retrieved via AI Analytics 2026-06-15 from https://api.ai-analytics.org/clinical/NCT00913614. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*