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)
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.