A Phase III multi-center double-blind randomized withdrawal study of LCI699 following a 24 week single-arm open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushings disease (PRIME)
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- STATUS
- Recruiting
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- participants needed
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Summary
The study aims to confirm the long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease who have had had surgery that has not been successful, or are not a good surgical candidate, or refuse surgery, and have not received radiation treatment for this condition within the past three years. . LC1699 is taken in pill form twice a day. Once eligibility has been confirmed, the study has four periods plus an optional extension period.
Details
| Condition | Cushing syndrome |
|---|---|
| Age | 1years - 99years |
| Clinical Study Identifier | 820801 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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