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Corticosteroid

osilodrostat for Cushing's Syndrome

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

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 up to 5 years

Awards & highlights

Study Summary

This trial is to study the long-term safety of osilodrostat in patients who have already benefited from it in the past.

Eligible Conditions

Cushing's Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse/serious adverse events

Secondary outcome measures

Percentage of patients with clinical benefit

Side effects data

From 2019 Phase 3 trial • 137 Patients • NCT02180217

52%

Nausea

48%

Headache

36%

Fatigue

32%

Vomiting

26%

Adrenal insufficiency

26%

Dizziness

21%

Blood corticotrophin increased

21%

Hypertension

21%

Diarrhoea

21%

Urinary tract infection

20%

Pyrexia

20%

Nasopharyngitis

20%

Blood testosterone increased

18%

Arthralgia

18%

Hormone level abnormal

17%

Decreased appetite

17%

Hypokalaemia

17%

Asthenia

17%

Myalgia

15%

Influenza

15%

Cough

15%

Rash

14%

Acne

14%

Oedema peripheral

12%

Abdominal pain

12%

Glucocorticoid deficiency

12%

Dyspepsia

11%

Anxiety

11%

Depression

11%

Alopecia

11%

Insomnia

11%

Malaise

11%

Oropharyngeal pain

11%

Upper respiratory tract infection

11%

Back pain

11%

Dry skin

11%

Pruritus

Anaemia

Bronchitis

Pain in extremity

Pituitary tumour benign

Muscle spasms

Constipation

Weight decreased

Oedema

Sleep disorder

Gastroenteritis

Hirsutism

Dry mouth

Dyspnoea

Sinusitis

Hypoaesthesia

Vision blurred

Alanine aminotransferase increased

Rhinitis allergic

Rhinorrhoea

Pituitary tumour

Aspartate aminotransferase increased

Skin hyperpigmentation

Chest discomfort

Contusion

Migraine

Irritability

Abdominal pain upper

Abdominal distension

Renin increased

Nasal congestion

Hypotension

Tachycardia

Adrenocortical insufficiency acute

VIth nerve paralysis

Toothache

Musculoskeletal pain

Neck pain

Somnolence

Hyperhidrosis

Dermatitis

Memory impairment

Hordeolum

Dry eye

Vitamin D deficiency

Malignant pituitary tumour

Weight increased

Hypertriglyceridaemia

Menstruation irregular

Urticaria

Chills

11-deoxycortisol increased

Dermatitis contact

Eczema

Inappropriate antidiuretic hormone secretion

Pituitary infarction

Cholelithiasis

Cholecystitis

Ligament sprain

Hyponatraemia

Hypercalcaemia

Activated partial thromboplastin time prolonged

Cystitis glandularis

Venous thrombosis

Pituitary-dependent Cushing's syndrome

Syncope

Diplopia

Vaginal haemorrhage

Respiratory failure

Visual impairment

Pneumonia

Procedural headache

Idiopathic intracranial hypertension

Respiratory disorder

Ear pain

Pain

Lipase increased

Low density lipoprotein increased

Hypercholesterolaemia

Skin lesion

Chronic sinusitis

Metastases to liver

Tumour invasion

Cranial nerve disorder

Epistaxis

Pulmonary oedema

Hidradenitis

Cystitis

Blood cholesterol increased

Cortisol decreased

Cortisol free urine decreased

Hyperglycaemia

Keratitis fungal

Lymphadenopathy

Gastritis

Influenza like illness

Haemoglobin decreased

Dehydration

Groin pain

Metrorrhagia

Vocal cord polyp

Gastrooesophageal reflux disease

Cortisol free urine increased

Osteoarthritis

Osteopenia

100%

80%

60%

40%

20%

Study treatment Arm

Non-randomized

Osilodrostat

LCI699 Placebo

All Participants

Trial Design

1Treatment groups

Experimental Treatment

Group I: osilodrostatExperimental Treatment1 Intervention

open label, with patients receiving same dose as provided in the parent study

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

osilodrostat

2015

Completed Phase 3

~260

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,170 Total Patients Enrolled

2 Trials studying Cushing's Syndrome

35 Patients Enrolled for Cushing's Syndrome

RECORDATI GROUPLead Sponsor

12 Previous Clinical Trials

4,379 Total Patients Enrolled

1 Trials studying Cushing's Syndrome

104 Patients Enrolled for Cushing's Syndrome

RecordatiStudy DirectorRecordati AG

2 Previous Clinical Trials

613 Total Patients Enrolled

Media Library

Osilodrostat (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03606408 — Phase 2

Cushing's Syndrome Research Study Groups: osilodrostat

Cushing's Syndrome Clinical Trial 2023: Osilodrostat Highlights & Side Effects. Trial Name: NCT03606408 — Phase 2

Osilodrostat (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03606408 — Phase 2

Frequently Asked Questions

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

What is the current enrollment for this experiment?

"At present, this experiment is not recruiting patients. Initially posted on October 5th 2018 and last edited on May 2nd 2022, it has since been surpassed by thirteen hundred eighty-nine other clinical trials searching for individuals with cushing's syndrome as well as two additional trials admitting participants to the same treatment."

Answered by AI

Is this endeavor the inaugral effort of its kind?

"This medication has been under scientific scrutiny since 2018, when Novartis Pharmaceuticals first conducted a Phase 1 trial with 180 individuals. Subsequently obtaining drug approval in its second phase of trials, today it is being studied at 29 locations across 22 nations around the world."

Answered by AI

Are there any other research projects that have been conducted to evaluate this treatment?

"In 2018, Novartis Investigative Site began examining this proposed treatment. Ten trials have already concluded and there are 2 ongoing ones which primarily take place in Sherbrooke, Quebec."

Answered by AI

Where can potential participants find this research endeavor?

"This study is enrolling patients at Recordati Investigative Site in Sherbrooke, Quebec; Memorial Sloan Kettering Cancer Center in Montreal and New york; Cleveland Clinic Foundation in Ohio. Additionally, there are 16 other trial sites dotted across the United States of America."

Answered by AI

Is this research endeavor open to individuals below the age of fifty-five?

"In order to satisfy this clinical trial's requirements for inclusion, the age range of participants must lie between 18 and 75 years old."

Answered by AI

To what demographic is enrollment in this research project limited?

"Aspiring participants must possess cushing's syndrome and have a minimum age of 18 while not exceeding 75. This trial is aiming to enrol 180 individuals in total."

Answered by AI

Is enrollment for the trial still ongoing?

"Unfortunately, this proposed trial is not presently enlisting. It was first announced on October 5th 2018 and last updated on May 2nd 2022. However, there are a total of 1389 studies currently admitting patients with Cushing's Syndrome as well as two active treatments enrolling candidates for this particular condition."

Answered by AI

Has this treatment been given the go-ahead from the Food and Drug Administration?

"Due to limited evidence backing efficacy, the safety of this treatment was evaluated as a 2 on our scale. However, there is already some data that can vouch for its safety and tolerability."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699

2018. "Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03606408.

All > Cushings Syndrome