NCT00913614 (PKiDs) is a Phase 1 clinical trial of Eplivanserin (SR46349) in Sleep Initiation and Maintenance Disorders, sponsored by Sanofi.

Who is sponsoring NCT00913614?

NCT00913614 is sponsored by Sanofi.

What drugs are being tested in NCT00913614?

Interventions in NCT00913614: Eplivanserin (SR46349).

What condition does NCT00913614 study?

NCT00913614 studies Sleep Initiation and Maintenance Disorders.

Is NCT00913614 still recruiting?

NCT00913614 is currently completed. Last updated 29 November 2010.

Last reviewed 2010-11-29 · How we verify

NCT00913614: PKiDs

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Single Dose, Open Label Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Three Different Eplivanserin Doses in Children Aged 6-17 Years With Insomnia of Various Origins

Completed Phase 1 Last updated 29 November 2010

What this trial tests

Phase 1 trial testing Eplivanserin (SR46349) in Sleep Initiation and Maintenance Disorders in 41 participants. Completed in 1 December 2009.

Timeline

1 June 2009

Primary endpoint
1 December 2009

1 December 2009

Quick facts

Lead sponsor	Sanofi
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	1 June 2009
Primary completion	1 December 2009
Estimated completion	1 December 2009
Sites	1 location across United States

Drugs / interventions tested

Eplivanserin (SR46349) — full drug profile →

Conditions studied

Sleep Initiation and Maintenance Disorders — all drugs for Sleep Initiation and Maintenance Disorders →

Sponsor

Sanofi — full company profile →

Who can join

Adults 6 to 17, any sex, with Sleep Initiation and Maintenance Disorders. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety in terms of adverse events, laboratory tests, vital signs, ECGs
Time frame: Up to 12 days following single dose administration
Pharmacokinetics parameters
Time frame: on Day 1, Day 2, Day 5, Day 7 and Day 10

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Sleep Initiation and Maintenance Disorders

Currently open trials in the same condition.

NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
NCT05000528 — Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia · NA · recruiting
NCT03642028 — Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress · Phase 4 · recruiting
NCT04598672 — Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease · NA · active not recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00913614 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 29 November 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00913614.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing