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Steroidogenesis Inhibitor

Levoketoconazole for Cushing 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
Currently in a named patient program or other Expanded Access Program receiving levoketoconazole
Were levoketoconazole-naïve prior to entry and received early rescue therapy with open-label levoketoconazole in Study COR-2017-01.
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

OPTICS 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 Syndrome
  • Cushing's Disease

OPTICS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are currently taking levoketoconazole through a program designed for specific patients or people who need expanded access to the medication.
Select...
You have not taken levoketoconazole before and you were given levoketoconazole during a previous study.

OPTICS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Nausea
9%
Fatigue
9%
Headache
5%
Ovarian cyst
5%
Depression
5%
Paraesthesia
5%
Cystitis
5%
Tonsillitis
5%
Pyrexia
5%
Hypokalemia
5%
Constipation
5%
Diarrhoea
5%
Dyspepsia
5%
Vomiting
5%
Decreased appetite
5%
Hypercholesterolaemia
5%
Hypokalaemia
5%
Tachycardia paroxysmal
5%
Dry skin
5%
Adrenal insufficiency
5%
Wrist fracture
5%
Gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levoketoconazole-ITT RW Phase
Placebo- ITT RW Phase
Safety Population

OPTICS 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
2 Trials studying Cushing Syndrome
178 Patients Enrolled for Cushing Syndrome
Fredric Cohen, MDStudy ChairCortendo AB

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have medical professionals tried this specific treatment before on patients?

"There is one ongoing global clinical trial for Levoketoconazole that started in 2019. This study, which is sponsored by Cortendo AB, has completed its Phase 3 drug approval stage. A total of 60 patients have been involved across 7 cities and 11 countries. 5 studies have been completed since 2019."

Answered by AI

Are there other examples of Levoketoconazole being used in a medical capacity?

"Currently, there is 1 ongoing clinical trial involving Levoketoconazole. This active trial is in its third stage. Most of the research for Levoketoconazole takes place in Budapest and Ohio, but there are 30 different locations running these studies."

Answered by AI

Does the FDA sanction Levoketoconazole for public usage?

"There is evidence from multiple sources that Levoketoconazole is safe for use, so it received a score of 3."

Answered by AI
~8 spots leftby Mar 2025