Congenital Adrenal HyperplasiaPhase 3RESTORENCT03532022
Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy
A Phase 3 study testing Chronocort® in people with Congenital Adrenal Hyperplasia, run by Neurocrine UK Limited at 1 site in United States.
Trial summary
This study is an open-label, randomised, titration-blinded, parallel arm, multicenter study to compare twice daily Chronocort® with standard care in participants with Congenital Adrenal Hyperplasia (CAH). This study will be conducted in the USA. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Congenital Adrenal Hyperplasia
- What is being tested?
- Chronocort®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2018to 9 Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply (note: if a participant fails to meet an inclusion criterion, re-screening is permitted if the Investigator considers that the circumstances leading to screening failure will not be relevant when the participant is re-screened at a later time):
- Age
- Participant must be aged 16 years or older at the time of signing the informed consent.
- In participants aged <18 years, height velocity must be less than 2 cm in the last year and puberty must be completed.
- Type of Participant and Disease Characteristics
- Participants with known CAH due to 21-hydroxylase deficiency (classic CAH) diagnosed in childhood with documented (at any time) elevated 17-OHP or A4 and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned glucocorticoids).
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- Sex
- Male and female participants
- Male participants:
- A male participant must agree to use contraception as detailed in Section 10.4 of this protocol during the treatment period and refrain from donating sperm during this period.
- Female participants:
- A female participant is eligible to participate if she is not pregnant (Section 10.4), not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Section 10.4. OR ii. A WOCBP with a negative pregnancy test at entry into the study who agrees to follow the contraceptive guidance in Section 10.4 during the treatment period.
- Note: females presenting with oligomenorrhea or amenorrhea who are aged ≤55 years should be considered potentially fertile and therefore, as well as undergoing pregnancy testing like all other female participants, will be expected to be using an acceptable method of contraception which should have been ongoing for ≥90 days prior to the study.
- Informed Consent
- Capable of giving signed informed consent as described in Section 10.1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply (note: if a participant meets an exclusion criterion, re-screening is permitted if the Investigator considers that the circumstances leading to screening failure will not be relevant when the participant is re-screened at a later time):
- Medical Conditions
- Clinical or biochemical evidence of hepatic or renal disease e.g. creatinine > 2 times the upper limit of normal (ULN) or elevated liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the ULN).
- History of bilateral adrenalectomy.
- History of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study).
- Participants who have type 1 diabetes or any participant who is receiving insulin.
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- Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study.
- Prior/Concomitant Therapy
- Participants on regular daily oral steroids for any indication other than CAH. Note: a participant should not be given any steroids (even on an irregular basis) within 5 days of a study visit. If there is a medical need for steroid treatment within this time frame then the visit should be postponed until a 5-day interval has elapsed.
- Co-morbid condition requiring daily administration of a medication or consumption of any material that interferes with the metabolism of glucocorticoids (examples provided at http://medicine.iupui.edu/clinpharm/ddis/clinical-table/).
- Participants who are receiving <10 mg hydrocortisone dose at baseline or the hydrocortisone dose equivalent.
- Prior/Concurrent Clinical Study Experience
- Participation in another clinical study of an investigational or licensed drug or device within the 12 weeks prior to screening or during the study.
- Inclusion in any natural history or translational research study that would require evaluation of androgen levels during the study period outside of this study protocol assessments.
- Participants who have previously been exposed to Chronocort in studies DIUR-003, DIUR-005 or DIUR-006.
- Other Exclusions
- Participants who routinely work night shifts and so do not sleep during the usual night-time hours.
- Participants unable to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes and Endocrinology Consultants PC
Morehead City, North Carolina, 28557
About this study
Official title: An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort® Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
This study is an open-label, randomised, titration-blinded, parallel arm, multicenter study to compare twice daily Chronocort® with standard care in participants with Congenital Adrenal Hyperplasia (CAH). This study will be conducted in the USA.
Read the detailed description
It will compare the efficacy, safety and tolerability of twice daily Chronocort® with standard care (using the participant's usual individualized standard glucocorticoid regimen) over a treatment period of 52 weeks in participants aged 16 years and over with known CAH due to 21-hydroxylase deficiency (classic CAH) diagnosed in childhood with documented (at any time) elevated 17-OHP or A4 and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned glucocorticoids).
- Conditions
- Congenital Adrenal Hyperplasia
- Being tested
- Chronocort®, Standard Care
- Medical subject headings
- Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronocort®Drug
Also called Hydrocortisone modified release capsules
Hydrocortisone modified release capsules - 5mg, 10mg and 20mg.
Standard CareDrug
Also called Hydrocortisone, Dexamethasone, Prednisone, Prednisolone
The subject's standard care regimen upon entering the study; this could consist of hydrocortisone, dexamethasone, prednisone or prednisolone.
| Study group | Role | What they receive |
|---|---|---|
| Chronocort | Experimental | Hydrocortisone modified release capsules - Chronocort®. 66 subjects will be randomised to this group using an interactive web response system (IWRS). Receives: Drug: Chronocort® |
| Standard Care | Active comparator | Subjects participating in this arm will continue to receive their normal, standard care (hydrocortisone, dexamethasone, prednisone, prednisolone) once enrolled on the study. 66 subjects will be randomised to this arm using an interactive web response system (IWRS). Receives: Drug: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of Chronocort® versus standard care in terms of responder rate.
The proportion of participants after 52 weeks of treatment in the Chronocort® and standard care treatment groups achieving biochemical control. Participants with 17 OHP and A4 in the optimal (for 17-OHP) and reference range (for A4) at both timepoints of 09:00 and 13:00 hours will be classified as 'in biochemical control'; if at least one of these measurements is outside of the optimal (for 17-OHP) or reference range (for A4) they will be classified as 'not in biochemical control'.
Measured: 52 weeks
Secondary outcomes (33)
Impact of both treatments on markers of fertility.
Proportion of participants who are "responders" at Weeks 26 and 52 i.e. restoration of menses/more regular menses in women (patient diary used to record menstrual cycle details in pre menopausal women who have not had a hysterectomy and are not using hormonal contraception), and luteinizing hormone (LH) in men that was outside the normal range at baseline but moves to within the normal range during the study
Measured: Weeks 26 & 52
Impact of both treatments on hirsutism in female participants.
Change in hirsutism will be assessed at Weeks 26 and 52 using a 10 cm VAS ranging from 'No Symptoms' to 'Very Severe Symptoms' which will be completed by the participant.
Measured: Weeks 26 & 52
Impact of both treatments on acne.
Change in acne assessed at Weeks 26 and 52 using a 10 cm visual analogue scale (VAS) ranging from 'No Symptoms' to 'Very Severe Symptoms' which will be completed by the participant.
Measured: Weeks 26 & 52
Impact of both treatments on glycated hemoglobin (HbA1c) levels.
Change from baseline to Weeks 26 and 52 in glycated hemoglobin (HbA1c) levels.
Measured: Weeks 26 & 52
Impact of both treatments on waist circumference (in centimetres).
Change from baseline to Weeks 26 and 52 in waist circumference (cm).
Measured: Weeks 26 & 52
Impact of both treatments on body weight (in kilograms).
Change from baseline to Weeks 26 and 52 in body weight (kg).
Measured: Weeks 26 & 52
Impact of both treatments on quality of life (QoL) using SF-36® total score and the sub-domain of vitality.
Change from baseline to Weeks 26 and 52 in Quality of Life using SF-36® total score and the score for the vitality sub-domain.
Measured: Weeks 26 & 52
Impact of both treatments on Quality of Life using Multidimensional Assessment of Fatigue (MAF).
Change from baseline to Weeks 26 and 52 in Quality of Life using Multidimensional Assessment of Fatigue (MAF).
Measured: Weeks 26 & 52
Impact of both treatments on Quality of Life using EQ-5D™.
Change from baseline to Weeks 26 and 52 in Quality of Life using EQ-5D™.
Measured: Weeks 26 & 52
Safety and tolerability of Chronocort® relative to standard care
Incidence of clinical AEs, with a particular focus on adrenal crises.
Measured: 52 weeks
The need for additional glucocorticoid doses
Use of immediate release hydrocortisone from the sick day packs or use of any additional glucocorticoid treatment during the study.
Measured: 52 weeks
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - Red blood cell count and platelet count
Routine haematology assessments to compare red blood cell and platelet counts (absolute values) between the Chronocort arm and Standard Care arm.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - haemaglobin
Routine haematology assessments to compare haemaglobin concentrations (g/dL) between the Chronocort arm and Standard Care arm.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - haematocrit
Routine haematology assessments to compare haematocrit levels (ratio of red blood cells to total blood volume) between the Chronocort arm and Standard Care arm.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - mean corpuscular volume (MCV)
Routine haematology assessments to compare mean corpuscular volumes (volume of red blood cells) between the Chronocort arm and Standard Care arm.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - mean cell haemoglobin (MCH)
Routine haematology assessments to compare mean cell haemoglobin concentrations between the Chronocort arm and Standard Care arm.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - mean cell haemoglobin concentration (MCHC)
Routine haematology assessments to compare mean cell haemoglobin concentrations (as measured by dividing haematocrit by blood haemoglobin levels) between the Chronocort arm and Standard Care arm.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - Red cell distribution width (RDW)
Routine haematology assessments to compare Red cell distribution width (measured in micrometres) between the Chronocort arm and Standard Care arm.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - White blood cell count with differential (absolute and %): Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Routine haematology assessments to compare average White blood cell counts (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils) with differentials (absolute count and %) between the Chronocort arm and Standard Care arm.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of physical examinations.
Safety of Chronocort® compared to standard care as measured by the incidence of abnormal findings identified during physical examinations. The physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal and neurological systems for the purpose of safety monitoring and to determine subject eligibility. Investigators should pay special attention to clinical signs related to previous serious illnesses. Abnormal findings are recorded in the eCRF and are assessed for their clinical significance.
Measured: Baseline (Day 1), Week 26 & Week 52
Safety of Chronocort® compared to standard care by assessment of vital signs - Blood pressure
Systolic and diastolic blood pressure will be measured (in mmHg - millimetres of mercury) at each visit for safety monitoring purposes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of vital signs - Heart rate
Heart rate will be measured (in beats per minute) at each visit for safety monitoring purposes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of vital signs - Respiratory rate
Respiratory rate will be measured (in breaths per minute) at each visit for safety monitoring purposes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of vital signs - Oral body temperature
Oral body temperature (measured in Celsius) will be measured at each visit for safety monitoring purposes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Specific gravity
Specific gravity of urine (concentration of solutes) will be measured at each visit for safety monitoring purposes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - pH
Urine pH (potential of hydrogen - molar concentration of hydrogen ions) will be measured at each visit for safety monitoring purposes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Glucose
Urine glucose concentrations will be measured at each visit for safety monitoring purposes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Proteins
Urine protein concentrations will be measured at each visit for safety monitoring purposes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Blood
Concentration of blood molecules in urine will be measured at each visit for safety monitoring purposes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Ketones
Urine ketone concentrations will be measured at each visit for safety monitoring purposes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Bilirubin
Urine bilirubin concentrations will be measured at each visit for safety monitoring purposes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Urobilinogen by dipstick
Urobilinogen concentrations will be measured at each visit for safety monitoring purposes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of electrocardiogram (ECG).
A single 12-lead ECG will be recorded using an ECG machine that automatically calculates and measures PR, QRS, QT and QTc intervals (in milliseconds and voltage). ECG measurements should be preceded by 10 minutes of rest (semi-supine) in a quiet area. ECGs will be read at sites by the local investigator and any abnormal findings recorded in the eCRF and the original ECG source notes stored in the participant's source notes.
Measured: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start4 Oct 2018
- Primary completion17 Oct 2018
- Study completion9 Jul 2021
Why it stopped: Protocol re-design required following EU Phase III results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Adrenal HyperplasiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532022
- Sponsor's protocol ID
- DIUR-007
- Acronym
- RESTORE
- Status last verified
- Sep 2026
- First submitted
- 18 Apr 2018
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort® Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
- ClinicalTrials.gov ID
- NCT03532022
- Acronym / sponsor ID
- RESTORE / DIUR-007
- Conditions
- Congenital Adrenal Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol re-design required following EU Phase III results
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neurocrine UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, randomised, titration-blinded, parallel arm, multicenter study to compare twice daily Chronocort® with standard care in participants with Congenital Adrenal Hyperplasia (CAH). This study will be conducted in the USA.
Detailed description
It will compare the efficacy, safety and tolerability of twice daily Chronocort® with standard care (using the participant's usual individualized standard glucocorticoid regimen) over a treatment period of 52 weeks in participants aged 16 years and over with known CAH due to 21-hydroxylase deficiency (classic CAH) diagnosed in childhood with documented (at any time) elevated 17-OHP or A4 and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned glucocorticoids).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronocort | Experimental | Drug: Chronocort®Hydrocortisone modified release capsules - Chronocort®. 66 subjects will be randomised to this group using an interactive web response system (IWRS). |
| Standard Care | Active comparator | Drug: Standard CareSubjects participating in this arm will continue to receive their normal, standard care (hydrocortisone, dexamethasone, prednisone, prednisolone) once enrolled on the study. 66 subjects will be randomised to this arm using an interactive web response system (IWRS). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply (note: if a participant fails to meet an inclusion criterion, re-screening is permitted if the Investigator considers that the circumstances leading to screening failure will not be relevant when the participant is re-screened at a later time):
- Age
- Participant must be aged 16 years or older at the time of signing the informed consent.
- In participants aged <18 years, height velocity must be less than 2 cm in the last year and puberty must be completed.
- Type of Participant and Disease Characteristics
Key exclusion criteria (18 listed)
- Participants are excluded from the study if any of the following criteria apply (note: if a participant meets an exclusion criterion, re-screening is permitted if the Investigator considers that the circumstances leading to screening failure will not be relevant when the participant is re-screened at a later time):
- Medical Conditions
- Clinical or biochemical evidence of hepatic or renal disease e.g. creatinine > 2 times the upper limit of normal (ULN) or elevated liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the ULN).
- History of bilateral adrenalectomy.
- History of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study).
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 |
|---|---|---|
| Chronocort®Also: Hydrocortisone modified release capsulesHydrocortisone modified release capsules - 5mg, 10mg and 20mg. | Drug | Chronocort |
| Standard CareAlso: Hydrocortisone, Dexamethasone, Prednisone, PrednisoloneThe subject's standard care regimen upon entering the study; this could consist of hydrocortisone, dexamethasone, prednisone or prednisolone. | Drug | Standard Care |
Primary outcome
Non-inferiority of Chronocort® versus standard care in terms of responder rate.
Time frame: 52 weeks
The proportion of participants after 52 weeks of treatment in the Chronocort® and standard care treatment groups achieving biochemical control. Participants with 17 OHP and A4 in the optimal (for 17-OHP) and reference range (for A4) at both timepoints of 09:00 and 13:00 hours will be classified as 'in biochemical control'; if at least one of these measurements is outside of the optimal (for 17-OHP) or reference range (for A4) they will be classified as 'not in biochemical control'.
33 secondary outcomes
Impact of both treatments on markers of fertility.
Time frame: Weeks 26 & 52
Impact of both treatments on hirsutism in female participants.
Time frame: Weeks 26 & 52
Impact of both treatments on acne.
Time frame: Weeks 26 & 52
Impact of both treatments on glycated hemoglobin (HbA1c) levels.
Time frame: Weeks 26 & 52
Impact of both treatments on waist circumference (in centimetres).
Time frame: Weeks 26 & 52
Impact of both treatments on body weight (in kilograms).
Time frame: Weeks 26 & 52
Impact of both treatments on quality of life (QoL) using SF-36® total score and the sub-domain of vitality.
Time frame: Weeks 26 & 52
Impact of both treatments on Quality of Life using Multidimensional Assessment of Fatigue (MAF).
Time frame: Weeks 26 & 52
Impact of both treatments on Quality of Life using EQ-5D™.
Time frame: Weeks 26 & 52
Safety and tolerability of Chronocort® relative to standard care
Time frame: 52 weeks
The need for additional glucocorticoid doses
Time frame: 52 weeks
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - Red blood cell count and platelet count
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - haemaglobin
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - haematocrit
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - mean corpuscular volume (MCV)
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - mean cell haemoglobin (MCH)
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - mean cell haemoglobin concentration (MCHC)
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - Red cell distribution width (RDW)
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - White blood cell count with differential (absolute and %): Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of physical examinations.
Time frame: Baseline (Day 1), Week 26 & Week 52
Safety of Chronocort® compared to standard care by assessment of vital signs - Blood pressure
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of vital signs - Heart rate
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of vital signs - Respiratory rate
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of vital signs - Oral body temperature
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Specific gravity
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - pH
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Glucose
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Proteins
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Blood
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Ketones
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Bilirubin
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Urobilinogen by dipstick
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of electrocardiogram (ECG).
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chronocort® in people with Congenital Adrenal Hyperplasia, run by Neurocrine UK Limited at 1 site in United States.
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 16 inclusion and 18 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: withdrawn, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Non-inferiority of Chronocort® versus standard care in terms of responder rate. (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.