Endogenous Cushing's SyndromePhase 3SONICSNCT01838551
Treatment for Endogenous Cushing's Syndrome
A Phase 3 study testing Levoketoconazole in people with Endogenous Cushing's Syndrome, run by Cortendo AB at 42 sites in 15 countries.
Trial summary
The primary objectives of this study are to evaluate the clinical responder rate, defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endogenous Cushing's Syndrome
- What is being tested?
- Levoketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 42 sitesin 15 countries
- Study dates
- Aug 2014to Nov 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age
- Able to provide written informed consent prior to any study procedures being performed; eligible subjects must be able to understand the informed consent form prior to inclusion into the study.
- Confirmed diagnosis of newly diagnosed, persistent or recurrent Cushing's disease (CD) or endogenous CS of other etiology if subjects are not candidates for surgery or radiotherapy within the 18 months after enrollment.
- Previous medical records will be collected and used to support the diagnosis of CD or endogenous CS of other etiology, including the following etiologies:
- Ectopic adrenocorticotropic hormone (ACTH) secretion, i.e. ACTH not of pituitary origin
- Ectopic corticotropin-releasing hormone (CRH) secretion
Show all 15Show fewer
- Adrenal-dependent CS (i.e. adrenal adenoma (NOT carcinoma), adrenal hyperplasia, etc.)
- Etiology unknown.
- Must have elevated mean 24 hour UFC levels ≥1.5X ULN based on the normative range of the central lab assay and on a minimum of four measurements from adequately collected urine.
- In addition to elevated mean UFC, presence of abnormal values from one of the following tests:
- Abnormal DST: Elevated 8 AM serum cortisol ≥1.8 micrograms/dL (50 nmol/L) after 1 mg dexamethasone orally at 11 PM the evening prior (if not conducted already in the diagnostic workup of the subject within the previous 2 months before start of Screening Phase; in that case previous test results and details of conduct will need to be available by the Baseline Visit)
- Elevated late night salivary cortisol concentrations (at least two measurements) >ULN
- Previously irradiated subjects with CD or endogenous CS of other etiology will be allowed as long as the radiation treatment occurred > 4 years ago and subjects have not exhibited evidence for improvement in their underlying CD for 6 months prior to the Screening visit. The total number of previously irradiated subjects enrolled in this study will not exceed 10.
- Subjects with CD or CS of other etiology who are not candidates for surgery, refuse surgery, or in whom surgery will be delayed for at least 18 months following enrollment. Subjects may be allowed to participate in the trial while awaiting surgery, but must agree to complete this study prior to surgery.
- Subjects on treatment for CD or endogenous CS of other etiology for whom treatment has been inadequate or not well tolerated must agree to minimum washout periods prior to the Baseline Visit as specified.
Who cannot join
- Subjects with Pseudo-Cushing's syndrome based on assessment of the Investigator.
- Subjects with cyclic CS based on assessment of the Investigator
- Subjects with a non-endogenous source of hypercortisolism such as exogenous source of glucocorticoids or therapeutic use of ACTH.
- Known inherited syndrome as the cause of hypercortisolism, including but not limited to multiple endocrine neoplasia Type 1, McCune Albright Syndrome and Carney Complex
- Subjects with adrenal carcinoma
- History of malignancy, other than thyroid, early stage prostate, squamous cell and basal cell carcinoma, within 3 years prior to the Screening Phase.
Show all 10Show fewer
- Subjects with QTc interval of >470 msec during the Screening Phase.
- Pre-existing hepatic disease; subjects with mild to moderate hepatic steatosis consistent with fatty infiltration (non-alcoholic fatty liver disease [NAFLD] are allowed).
- History of documented or suspected drug-induced liver injury requiring drug discontinuation of ketoconazole or any azole antifungals.
- Subjects who receive any prohibited concomitant medication and cannot discontinue it safely prior to the Baseline Visit.
Trial locations and contacts
42 sites in 15 countries.
42 sites in 15 countries
United States9 sites
University of New Mexico HSC
Albuquerque, New Mexico, 87131
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 44195
UCLA School of Medicine
Los Angeles, California, 90095
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Allegheny Neuroendocrinology Center
Pittsburgh, Pennsylvania, 15212
Oregon Health & Science University
Portland, Oregon, 97239
Italy9 sites
Azienda Ospedaliera-Universitaria Ancona
Ancona, 60126
UOC di Endocrinologia, Dipartimento di Medicina Clinica e Sperimentale
Messina, 98125
Istituto Auxologico Italiano
Milan, 20149
University of Naples Federico II
Naples, 80131
SCDU Medicina Interna I Università di Torino Dipartimento di Scienze Cliniche e Biologiche
Orbassano, 10043
University of Padua
Padova, 35128
Institute of Medical Pathology
Roma, 00168
Azienda Ospedaliero - Universitaria Città della Salute e della Scienza di Torino
Torino, 10126
Policlinico GB Rossi
Verona, 37134
Poland5 sites
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338
Terpa Sp.z.o.o
Lublin, 20-333
Szpital Kliniczny im. Heliodora Swiecickiego
Poznan, 60-355
Outpatient Clinic: Reuma Centrum
Warsaw, 04-305
Samodzielny Publiczny Szpital Kliniczny Nr 1
Wroclaw, 50367
Israel3 sites
Bnail Zion Medical Center Institute of Endocrinology & Metabolism
Haifa, 31048
Institute of Endocrinology & Metabolism, Rabin Medical Center
Petah Tikva, 49100
Sourasky Medical Center, Endocrinology & Metabolism
Tel Aviv, 64239
Spain3 sites
Hospital Universidad De La Ribera
Alzira, Valencia, 46600
Endocrinologia, Hospital Sant Pau,Universitat Autònoma de Barcelona
Barcelona, 08026
Hospital Universitario Reina Sofía
Córdoba, 14004
Denmark2 sites
Aarhus University Hospital
Aarhus, 8000
Rigshospitalet,Copenhagen University Hospital
Copenhagen, DK-2100
Netherlands2 sites
Leiden University, Leiden University Medical Center, Dept. of Endocrinology
Leiden, 2333 ZA
Erasmus MC, Dpt. Of Internal Medicine, Division of Endocrinology
Rotterdam, 3015 CE
Turkey (Türkiye)2 sites
Bezmi Alem Vakıf Üniversitesi Endokrinoloji Bölümü Adnan
Istanbul, 34093
Istanbul University Medical Faculty
Istanbul, 34303
Belgium1 site
University Hospitals Leuven Department of Endocrinology
Leuven, 3000
Bulgaria1 site
University Specialized Hospital for Active Treatment in Endocrinology (USHATE)
Sofia, 1431
Canada1 site
St. Pauls Hospital/Vancouver General Hospital
Vancouver, British Columbia, V6Z 1Y6
Czechia1 site
Vseobecna fakultni nemocnice v Praze - III. Interni klinika VFN a 1. LF UK
Prague, 128 08
France1 site
Hôpital de la CONCEPTION, Service d'Endocrinologie, Diabète et Maladies Métaboliques
Marseille, 13385
About this study
Official title: An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome
The primary objectives of this study are to evaluate the clinical responder rate, defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of hypercortisolism.
Read the detailed description
This is an open label, single arm study with a Screening Phase, a Dose Titration Phase, a 6-month Maintenance Phase, and a 6-month Extended Evaluation Phase designed to assess efficacy, safety, tolerability, and PK of COR-003 in subjects with endogenous CS.
Following an initial screening and washout period, as applicable, this study will be conducted in three treatment phases as follows:
- Dose Titration Phase: approximately 2 to 21 weeks to achieve an effective and tolerable maximum dose (the Therapeutic Dose). Dose titration will occur in increments of 150 mg with a starting dose of 150 mg twice daily (BID) over a period of approximately 2 to 21 weeks to achieve an effective and tolerable maximum dose (the Therapeutic Dose).
- Maintenance Phase: 6 months of treatment at the Therapeutic Dose following the Dose Titration Phase. Once the Therapeutic Dose has been reached and confirmed from the mean of a total of four adequately collected 24 hour urine collections for UFC measurements, subjects will enter into the Maintenance Phase of the study and will be asked to return to the clinic monthly for 6 months for assessment of efficacy and safety. During the Maintenance Phase, doses may not be increased to maintain UFC levels at or below ULN of the assay unless it is confirmed that a dose increase is deemed medically necessary at the discretion of the Investigator after discussion with the Medical Monitor. Prior to the End of Maintenance Phase Visit, four complete 24 hour urine collections will be obtained and subjects may enter the Extended Evaluation Phase.
- Extended Evaluation Phase: 6 months of continued treatment after the Maintenance Phase. In the 6-month Extended Evaluation Phase, subjects will return to the clinical site every 90 days (±14 days) for safety and efficacy evaluations.
Efficacy will be assessed primarily by measuring mean UFC concentrations at specified times as described in the clinical protocol. Safety will be assessed primarily by physical examinations with vital sign measurements, adverse events, clinical laboratory measures, electrocardiography, and pituitary MRI.
An independent Data Safety Monitoring Board (DSMB) will review the safety of the drug throughout the study. Membership of the DSMB is described in a Charter.
- Conditions
- Endogenous Cushing's Syndrome
- Being tested
- Levoketoconazole
- Keywords
- Cushing's disease, ectopic ACTH, adrenal Cushing's
- Medical subject headings
- Pituitary ACTH Hypersecretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevoketoconazoleDrug
Also called COR-003
Levoketoconazole is the 2S,4R- enantiomer derived from racemic ketoconazole
| Study group | Role | What they receive |
|---|---|---|
| Levoketoconazole DL0 | Experimental | Levoketoconazole Tablets Dose Level 0 Once Daily Receives: Drug: Levoketoconazole |
| Levoketoconazole DL1 | Experimental | Levoketoconazole Tablets Dose Level 1 Twice Daily Receives: Drug: Levoketoconazole |
| Levoketoconazole DL2 | Experimental | Levoketoconazole Tablets Dose Level 1 Twice Daily Receives: Drug: Levoketoconazole |
| Levoketoconazole DL3 | Experimental | Levoketoconazole Tablets Dose Level 3 Twice Daily Receives: Drug: Levoketoconazole |
| Levoketoconazole DL4 | Experimental | Levoketoconazole Tablets Dose Level 4 Twice Daily Receives: Drug: Levoketoconazole |
| Levoketoconazole DL5 | Experimental | Levoketoconazole Tablets Dose Level 5 Twice Daily Receives: Drug: Levoketoconazole |
| Levoketoconazole DL6 | Experimental | Levoketoconazole Tablets Dose Level 6 Twice Daily Receives: Drug: Levoketoconazole |
| Levoketoconazole DL7 | Experimental | Levoketoconazole Tablets Dose Level 7 Twice Daily Receives: Drug: Levoketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization in Urinary Free Cortisol in Patients With Endogenous Cushing's Syndrome.
The response to COR-003 is defined as mean UFC concentration ≤ULN following 6 months of maintenance phase therapy without a prior dose increase during that phase. The proportion of responders at the End of Maintenance Phase visit, following 6 months of treatment in the Maintenance Phase, for all dose groups combined was estimated using a generalized linear model with repeated measurements based on a binomial distribution with a logit link function and with region (US vs. non-US), concurrent CS medical conditions (diabetes [Yes/No], hypertension [Yes/No]), age (rounded median split based on the ITT population), sex, disease duration (years), prior CS medication (Yes/No), prior radiation therapy (Yes/No) as Baseline covariates and visit as an independent factor.
The least squares mean (LSMEAN) estimate of the UFC response after 6 months of treatment in the Maintenance Phase alongside its 95% Wald CI is presented.
Measured: 6 months of maintenance phase therapy without a prior dose increase during that phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startAug 2014
- Primary completionApr 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endogenous Cushing's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose titration
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cortendo AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fredric J Cohen, MD, Study director, Cortendo AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838551
- Sponsor's protocol ID
- COR-2012-01
- Acronym
- SONICS
- Status last verified
- Mar 2021
- First submitted
- 19 Apr 2013
- Last updated
- 19 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Publications
Fleseriu M, Pivonello R, Elenkova A, Salvatori R, Auchus RJ, Feelders RA, Geer EB, Greenman Y, Witek P, Cohen F, Biller BMK. Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial. Lancet Diabetes Endocrinol. 2019 Nov;7(11):855-865. doi: 10.1016/S2213-8587(19)30313-4. Epub 2019 Sep 18.
PubMed 31542384Geer EB, Salvatori R, Elenkova A, Fleseriu M, Pivonello R, Witek P, Feelders RA, Bex M, Borresen SW, Puglisi S, Biller BMK, Cohen F, Pecori Giraldi F. Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing's syndrome. Pituitary. 2021 Feb;24(1):104-115. doi: 10.1007/s11102-020-01103-6. Epub 2020 Nov 20.
PubMed 33216275Pivonello R, Elenkova A, Fleseriu M, Feelders RA, Witek P, Greenman Y, Geer EB, Perotti P, Saiegh L, Cohen F, Arnaldi G. Levoketoconazole in the Treatment of Patients With Cushing's Syndrome and Diabetes Mellitus: Results From the SONICS Phase 3 Study. Front Endocrinol (Lausanne). 2021 Apr 7;12:595894. doi: 10.3389/fendo.2021.595894. eCollection 2021.
PubMed 33897615
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome
- ClinicalTrials.gov ID
- NCT01838551
- Acronym / sponsor ID
- SONICS / COR-2012-01
- Conditions
- Endogenous Cushing's Syndrome
- Keywords
- Cushing's disease, ectopic ACTH, adrenal Cushing's
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Cortendo ABIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Posted 19 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to evaluate the clinical responder rate, defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of hypercortisolism.
Detailed description
This is an open label, single arm study with a Screening Phase, a Dose Titration Phase, a 6-month Maintenance Phase, and a 6-month Extended Evaluation Phase designed to assess efficacy, safety, tolerability, and PK of COR-003 in subjects with endogenous CS.
Following an initial screening and washout period, as applicable, this study will be conducted in three treatment phases as follows:
- Dose Titration Phase: approximately 2 to 21 weeks to achieve an effective and tolerable maximum dose (the Therapeutic Dose). Dose titration will occur in increments of 150 mg with a starting dose of 150 mg twice daily (BID) over a period of approximately 2 to 21 weeks to achieve an effective and tolerable maximum dose (the Therapeutic Dose).
- Maintenance Phase: 6 months of treatment at the Therapeutic Dose following the Dose Titration Phase. Once the Therapeutic Dose has been reached and confirmed from the mean of a total of four adequately collected 24 hour urine collections for UFC measurements, subjects will enter into the Maintenance Phase of the study and will be asked to return to the clinic monthly for 6 months for assessment of efficacy and safety. During the Maintenance Phase, doses may not be increased to maintain UFC levels at or below ULN of the assay unless it is confirmed that a dose increase is deemed medically necessary at the discretion of the Investigator after discussion with the Medical Monitor. Prior to the End of Maintenance Phase Visit, four complete 24 hour urine collections will be obtained and subjects may enter the Extended Evaluation Phase.
- Extended Evaluation Phase: 6 months of continued treatment after the Maintenance Phase. In the 6-month Extended Evaluation Phase, subjects will return to the clinical site every 90 days (±14 days) for safety and efficacy evaluations.
Efficacy will be assessed primarily by measuring mean UFC concentrations at specified times as described in the clinical protocol. Safety will be assessed primarily by physical examinations with vital sign measurements, adverse events, clinical laboratory measures, electrocardiography, and pituitary MRI.
An independent Data Safety Monitoring Board (DSMB) will review the safety of the drug throughout the study. Membership of the DSMB is described in a Charter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Dose titration
| Arm | Type | Receives |
|---|---|---|
| Levoketoconazole DL0 | Experimental | Drug: LevoketoconazoleLevoketoconazole Tablets Dose Level 0 Once Daily |
| Levoketoconazole DL1 | Experimental | Drug: LevoketoconazoleLevoketoconazole Tablets Dose Level 1 Twice Daily |
| Levoketoconazole DL2 | Experimental | Drug: LevoketoconazoleLevoketoconazole Tablets Dose Level 1 Twice Daily |
| Levoketoconazole DL3 | Experimental | Drug: LevoketoconazoleLevoketoconazole Tablets Dose Level 3 Twice Daily |
| Levoketoconazole DL4 | Experimental | Drug: LevoketoconazoleLevoketoconazole Tablets Dose Level 4 Twice Daily |
| Levoketoconazole DL5 | Experimental | Drug: LevoketoconazoleLevoketoconazole Tablets Dose Level 5 Twice Daily |
| Levoketoconazole DL6 | Experimental | Drug: LevoketoconazoleLevoketoconazole Tablets Dose Level 6 Twice Daily |
| Levoketoconazole DL7 | Experimental | Drug: LevoketoconazoleLevoketoconazole Tablets Dose Level 7 Twice Daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female ≥18 years of age
- Able to provide written informed consent prior to any study procedures being performed; eligible subjects must be able to understand the informed consent form prior to inclusion into the study.
- Confirmed diagnosis of newly diagnosed, persistent or recurrent Cushing's disease (CD) or endogenous CS of other etiology if subjects are not candidates for surgery or radiotherapy within the 18 months after enrollment.
- Previous medical records will be collected and used to support the diagnosis of CD or endogenous CS of other etiology, including the following etiologies:
- Must have elevated mean 24 hour UFC levels ≥1.5X ULN based on the normative range of the central lab assay and on a minimum of four measurements from adequately collected urine.
Key exclusion criteria (10 listed)
- Subjects with Pseudo-Cushing's syndrome based on assessment of the Investigator.
- Subjects with cyclic CS based on assessment of the Investigator
- Subjects with a non-endogenous source of hypercortisolism such as exogenous source of glucocorticoids or therapeutic use of ACTH.
- Known inherited syndrome as the cause of hypercortisolism, including but not limited to multiple endocrine neoplasia Type 1, McCune Albright Syndrome and Carney Complex
- Subjects with adrenal carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevoketoconazoleAlso: COR-003Levoketoconazole is the 2S,4R- enantiomer derived from racemic ketoconazole | Drug | Levoketoconazole DL0, Levoketoconazole DL1, Levoketoconazole DL2, Levoketoconazole DL3, Levoketoconazole DL4, Levoketoconazole DL5, Levoketoconazole DL6, Levoketoconazole DL7 |
Primary outcome
Normalization in Urinary Free Cortisol in Patients With Endogenous Cushing's Syndrome.
Time frame: 6 months of maintenance phase therapy without a prior dose increase during that phase
The response to COR-003 is defined as mean UFC concentration ≤ULN following 6 months of maintenance phase therapy without a prior dose increase during that phase. The proportion of responders at the End of Maintenance Phase visit, following 6 months of treatment in the Maintenance Phase, for all dose groups combined was estimated using a generalized linear model with repeated measurements based on a binomial distribution with a logit link function and with region (US vs. non-US), concurrent CS medical conditions (diabetes [Yes/No], hypertension [Yes/No]), age (rounded median split based on the ITT population), sex, disease duration (years), prior CS medication (Yes/No), prior radiation therapy (Yes/No) as Baseline covariates and visit as an independent factor. The least squares mean (LSMEAN) estimate of the UFC response after 6 months of treatment in the Maintenance Phase alongside its 95% Wald CI is presented.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31542384Fleseriu M, Pivonello R, Elenkova A, Salvatori R, Auchus RJ, Feelders RA, Geer EB, Greenman Y, Witek P, Cohen F, Biller BMK. Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial. Lancet Diabetes Endocrinol. 2019 Nov;7(11):855-865. doi: 10.1016/S2213-8587(19)30313-4. Epub 2019 Sep 18.
- Results publication: PubMed 33216275Geer EB, Salvatori R, Elenkova A, Fleseriu M, Pivonello R, Witek P, Feelders RA, Bex M, Borresen SW, Puglisi S, Biller BMK, Cohen F, Pecori Giraldi F. Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing's syndrome. Pituitary. 2021 Feb;24(1):104-115. doi: 10.1007/s11102-020-01103-6. Epub 2020 Nov 20.
- Derived from this study: PubMed 33897615Pivonello R, Elenkova A, Fleseriu M, Feelders RA, Witek P, Greenman Y, Geer EB, Perotti P, Saiegh L, Cohen F, Arnaldi G. Levoketoconazole in the Treatment of Patients With Cushing's Syndrome and Diabetes Mellitus: Results From the SONICS Phase 3 Study. Front Endocrinol (Lausanne). 2021 Apr 7;12:595894. doi: 10.3389/fendo.2021.595894. eCollection 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredric J Cohen, MD study director
Cortendo AB
42 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levoketoconazole in people with Endogenous Cushing's Syndrome, run by Cortendo AB at 42 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Italy, Poland, Israel, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalization in Urinary Free Cortisol in Patients With Endogenous Cushing's Syndrome. (time frame: 6 months of maintenance phase therapy without a prior dose increase during that phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01838551, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.