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NCT02776215
Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
Phase 1 trial testing tasimelteon in Circadian Rhythm Sleep Disorders in 24 participants. Completed in 20 December 2017.
20 December 2017
Quick facts
| Lead sponsor | Vanda Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 4 October 2016 |
| Primary completion | 20 December 2017 |
| Estimated completion | 20 December 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- tasimelteon — full drug profile →
Conditions studied
- Circadian Rhythm Sleep Disorders — all drugs for Circadian Rhythm Sleep Disorders →
- Non-24 Hour Sleep-Wake Disorder — all drugs for Non-24 Hour Sleep-Wake Disorder →
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
- Smith-Magenis Syndrome — all drugs for Smith-Magenis Syndrome →
Sponsor
Vanda Pharmaceuticals — full company profile →
Who can join
Adults 3 to 17, any sex, with Circadian Rhythm Sleep Disorders or Non-24 Hour Sleep-Wake Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.
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:
- PubMed search for NCT02776215
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of tasimelteon
Trials testing the same drug.
- NCT01218789 — Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light Percepti · Phase 3 · active not recruiting
Other Vanda Pharmaceuticals trials
Trials by the same sponsor.
- NCT07446439 — A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use · Phase 3 · recruiting
- NCT06804603 — A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use · Phase 2 · completed
- NCT06701396 — Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant · Phase 3 · recruiting
- NCT06494397 — Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions · Phase 1 · completed
- NCT05903924 — Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02776215 (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 Vanda Pharmaceuticals
- Last refreshed: 21 March 2024
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/NCT02776215.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing