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)

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)
Recruiting
1 years - 99 years
All
Phase 3
2 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cushing syndrome
  • Age: 1 years - 99 years
  • Gender: All
Updated on 19 Feb 2024. Study ID: 820801

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