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Mifepristone daily

Phase 2

Treatment-resistant PTSD | Small molecule | Psychiatry |Corcept Therapeutics Incorporated|Last Updated: Nov 14, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06689254REVERSE: Improving Treatment-resistant Post Traumatic Stress Disorder (PTSD) with Glucocorticoid Receptor (GR) AntagonismPHASE2 RECRUITING 60Nov 15, 2024Nov 15, 2026Nov 14, 20241 Netherlands
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Study Endpoints
Primary Endpoints
Improvement of PTSD symptoms
4 weeks after the start of the intervention (T2)

Measured with the monthly version of the CAPS-5 (Clinician Administered PTSD scale) in patients with treatment-resistant PTSD. Minimum and maximum score range from 0-80, with higher scores indicating greater PTSD symptom severity.

Secondary Endpoints
PTSD symptom severity
From baseline till 12 weeks after the start of the intervention (T3)
Long-term PTSD symptom severity
12 weeks after the start of the intervention (T3)
Loss of diagnosis
4 weeks after the start of the intervention (T2)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MifepristoneEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Mifepristone 1200 mg dailyDRUGOral tablets
PlaceboDRUGOral tablet
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Mastery of Dutch language * Age of ≥ 18 years of age and able to give written IC * Participant agrees to be randomized * DSM-5 diagnosis of PTSD, confirmed with clinical interview (CAPS-5) * Treatment-resistant PTSD * CAPS-5 score ≥ 30 * Nonresponse to two evidence-based ...

Countries:Netherlands
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06689254studyFirstPostDate: changed