Search the Community
Showing results for tags 'rescue'.
Brief Summary: This is a randomized, placebo-controlled, crossover study of SPI-62 in subjects with ACTH-dependent Cushing's syndrome. Subjects will receive each of the following 2 treatments for 12 weeks: SPI-62 and matching placebo Condition or disease Intervention/treatment Phase Cushing's Syndrome ICushing Disease Due to Increased ACTH Secretion Cortisol ExcessCortisol; Hypersecretion Cortisol Overproduction Ectopic ACTH Secretion Drug: SPI-62 Drug: Placebo Phase 2 Detailed Description: This is a multicenter, randomized, placebo-controlled, Phase 2 study to evaluate the pharmacologic effect, efficacy, and safety of SPI-62 in subjects with ACTH-dependent Cushing's syndrome. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in 3 periods: a 28-day screening period (Days -35 to -8), a 7-day baseline period (Days -7 to -1), and a 24-week treatment period (Day 1 of Week 1 to Day 168 ± 3 days of Week 24). Up to 26 subjects will be enrolled with the aim that 18 subjects with Cushing's disease will complete the study. Subjects will receive each of the following 2 treatments for 12 weeks: SPI-62 and matching placebo. Study Design Go to Study Type : Interventional (Clinical Trial) Estimated Enrollment : 26 participants Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Staggered parallel crossover Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome Actual Study Start Date : March 1, 2022 Estimated Primary Completion Date : March 15, 2023 Estimated Study Completion Date : August 15, 2023 More info at https://clinicaltrials.gov/ct2/show/record/NCT05307328