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Steroidogenesis Inhibitor

Open-label Treatment in Cushing's Syndrome (OPTICS Trial)

Phase 3
Waitlist Available
Research Sponsored by Cortendo AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to final study visit or up to a maximum of 3 years, whichever comes first.
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is for people with a disease that causes their body to make too much of the hormone cortisol. The drug being tested is designed to treat this by reducing the amount of cortisol the body makes.

Eligible Conditions
  • Cushing's Syndrome
  • Cushing's Disease
  • Cushing Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to final study visit or up to a maximum of 3 years, whichever comes first.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to final study visit or up to a maximum of 3 years, whichever comes first. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes from Baseline in 24-h UFC
Changes from Baseline in AEs/SAEs/AESI as assessed by CTCAE V4.03
Changes from Baseline in Late Night Salivary Cortisol

Side effects data

From 2020 Phase 3 trial • 84 Patients • NCT03277690
14%
Hypertension
9%
Fatigue
9%
Nausea
9%
Headache
5%
Vomiting
5%
Pyrexia
5%
Decreased appetite
5%
Hypercholesterolaemia
5%
Hypokalaemia
5%
Paraesthesia
5%
Cystitis
5%
Tonsillitis
5%
Depression
5%
Tachycardia paroxysmal
5%
Dry skin
5%
Adrenal insufficiency
5%
Wrist fracture
5%
Ovarian cyst
5%
Hypokalemia
5%
Constipation
5%
Diarrhoea
5%
Dyspepsia
5%
Gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levoketoconazole-ITT RW Phase
Placebo- ITT RW Phase
Safety Population

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: LevoketoconazoleExperimental Treatment1 Intervention
Levoketoconazole taken twice daily up to 1200 mg daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levoketoconazole
FDA approved

Find a Location

Who is running the clinical trial?

Cortendo ABLead Sponsor
5 Previous Clinical Trials
266 Total Patients Enrolled
Fredric Cohen, MDStudy ChairCortendo AB
~7 spots leftby Dec 2025
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