Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Safety and Efficacy of LCI699 in Cushing's Disease Patients
NCT01331239 · View on ClinicalTrials.gov ↗
Study Summary
This exploratory study is a proof of concept study to determine whether LCI699 can safely reduce the level of urinary free cortisol in patients with Cushing's disease. In addition, this study evaluated the long term efficacy and safety of LCI699 including an additional 12 week of treatment followed by a 12 month long term optional extension. A second extension provided patients who were clinically benefitting from LCI699 an opportunity to continue to have access to the drug until LCI699 was commercially available and reimbursed or through the availability of a local access program.
Conditions Studied
Interventions
- DRUG LCI699
Study Locations (10)
Other
- Novartis Investigative Site — Le Kremlin-Bicêtre
- Novartis Investigative Site — Paris
- Novartis Investigative Site — Ancona
- Novartis Investigative Site — Naples
- Novartis Investigative Site — Chiba
Illinois
- Northwestern University Endo, Metabolism and Molecular — Chicago
Massachusetts
- Massachusetts General Hospital Neuroendocrine Unit — Boston
Ohio
- Cleveland Clinic Foundation — Cleveland
Oregon
- Oregon Health and Science University SC — Portland
Hokkaido
- Novartis Investigative Site — Sapporo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-03-23 |
| Est. Completion | 2019-10-22 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01331239
The ClinicalTrials.gov registry entry for NCT01331239 describes a study currently listed as completed. 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 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Cushing Disease 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: NCT01331239 reports 10 study locations spanning 6 distinct geographic areas — top geographies include Other, Illinois, Massachusetts. 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 NCT01331239 about?
NCT01331239 is a clinical study titled "Safety and Efficacy of LCI699 in Cushing's Disease Patients". This exploratory study is a proof of concept study to determine whether LCI699 can safely reduce the level of urinary free cortisol in patients with Cushing's disease. In addition, this study evaluated the long term efficacy and safety of LCI699 including an additional 12 week of treatment followed...
What is the current status of trial NCT01331239?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2011-03-23. Estimated completion is 2019-10-22.
What conditions does trial NCT01331239 study?
This clinical trial studies the following conditions: Cushing Disease, Cushings Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01331239?
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 NCT01331239?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01331239 being conducted?
This trial has 10 study locations across Illinois, Massachusetts, Ohio, Oregon, Hokkaido. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.