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Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome
NCT03708900 · View on ClinicalTrials.gov ↗
Study Summary
Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.
Conditions Studied
Interventions
- DRUG LCI699
Study Locations (15)
Other
- Multiprofile Hospital for Active Treatment Sveta Marina EAD — Varna
- Hospital Necker Enfants Malades — Paris
- Robert Debre Hospital — Paris
- CHU Bicetre APHP Paris Saclay — Paris
- Ospedale Bambino Gesu — Roma
- University Clinical Center Ljubljana — Ljubljana
- Alder Hey Childrens NHS Foundation Trust — Liverpool
- The Royal London Childrens Hospital — London
California
- University of California San Francisco UCSF — San Francisco
Florida
- ABMED Clinical Research Corp — Cape Coral
Illinois
- Ann & Robert H. Lurie Children's Hospital — Chicago
Maryland
- National Institute of Child Health and Human Development — Bethesda
Texas
- Texas Valley Clinical Research — Weslaco
Brussels Capital
- UZ Brussel — Jette
PI
- Aziendal Ospedaliero Universitaria Pisana Presidio Ospedale di Cisanello — Pisa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-04-28 |
| Est. Completion | 2027-07-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03708900
The ClinicalTrials.gov registry entry for NCT03708900 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RECORDATI GROUP, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cushing Syndrome appearing as the primary indexed condition, and to 1 intervention — of which LCI699 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03708900 reports 15 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03708900 about?
NCT03708900 is a clinical study titled "Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome". Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.
What is the current status of trial NCT03708900?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2021-04-28. Estimated completion is 2027-07-21.
What conditions does trial NCT03708900 study?
This clinical trial studies the following conditions: Cushing Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03708900?
The interventions under investigation include: LCI699 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03708900?
This trial is sponsored by RECORDATI GROUP, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03708900 being conducted?
This trial has 15 study locations across California, Florida, Illinois, Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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