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NCT03708900 · ClinicalTrials.gov registry record · Phase 2

Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome

A Phase 2 study of Cushing Syndrome, sponsored by Recordati Group.

Recruiting
Registry status
Phase 2
Development phase
12
Enrollment target
15
Study locations

NCT03708900 is a Phase 2 study of Cushing Syndrome that is actively recruiting participants, run by Recordati Group. The registered enrollment target is 12 participants, below the 179-participant average among 9 other Cushing Syndrome trials with a reported enrollment target (93% lower). The trial reports 15 study locations across 8 states.

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The verdict

NCT03708900, a Phase 2 study of Cushing Syndrome, is actively recruiting participants, sponsored by Recordati Group.

RECRUITING
Registry status
Phase 2
Development phase
12 participants
Enrollment target
15
Study locations

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

FieldValue
Enrollment Target 12 participants
Start Date 2021-04-28
Est. Completion 2027-07-21
Phase Phase 2

Sponsor

Recordati Group

11 total trials

What the Registry Record Tells You About NCT03708900

The ClinicalTrials.gov registry entry for NCT03708900 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 9 other Cushing Syndrome trials with a reported enrollment target (93% lower). The listed sponsor is Recordati Group, which has 11 total studies on file at ClinicalTrials.gov.

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.

NCT03708900 reports 15 study locations spanning 8 distinct geographic areas - top geographies include Other, California, Florida.

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.

What interventions are being tested in trial NCT03708900?

The interventions under investigation include: LCI699 (DRUG).

Who is sponsoring clinical trial NCT03708900?

This trial is sponsored by Recordati Group, which has 11 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.