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An open-label, cross-over, multi-site, prospective, phase IIb study of effects on circadian rhythms and quality of life of modifieddual-release hydrocortisone Efmody™ versus immediate-release hydrocortisone in patients with Addison’s Disease
EU CTIS ID: 2023-503584-42-00
What this study is testing
The study primary objectives can be summarised as follows: To evaluate the effect of changing from immediate release hydrocortisone to modified release hydrocortisone Efmody™ therapy on quality QoL To evaluate the effect of changing from immediate release hydrocortisone to modified release hydrocortisone Efmody™ therapy on sleep efficiency To evaluate the effect of changing from immediate release hydrocortisone to modified release hydrocortisone Efmody™ therapy on patient interdaily stability To assess the effect changing from immediate release hydrocortisone to modified release hydrocortisone Efmody™ therapy on dim-light melatonin onset (DLMO).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female participants must be aged 18 years or older
- 2. Ability to comprehend the Patient Information Leaflet and to provide signed and dated informed consent.
- 3. Participants with an established diagnosis of Addison’s disease currently treated with immediate-release hydrocortisone as replacement therapy .
- 4. Participants on stable immediate-release hydrocortisone treatment for ≥ 4 weeks prior to enrolment.
- 5. Participants on a stable dose of fludrocortisone for ≥ 4 weeks prior to enrolment
- 6. Evidence of effective contraception for WOCBP* (see Appendix 11) *Women of childbearing potential (WOCBP) are eligible to participate if they are not pregnant, not breastfeeding and agree to adhere to the contraceptive guidance during the screening and treatment periods. Effective contraception should be maintained until treatment discontinuation. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. The effective methods of contraception are described in Appendix 11
You likely can't join if
- Participants aged < 18 years
- Conditions that would place the individual at increased risk or preclude the individual’s full compliance with or completion of the study – such as intellectual disability or cognitive impairment
- Patients who have difficulty understanding the required protocol and follow up instructions (e.g. language barriers)
- Participants with life expectancy of less than 6 months.
- Participants with a history of malabsorption and/or motility disorders due to risk of impaired cortisol exposure.
- Participants treated with agents that interfere with corticosteroid metabolism.
See the full eligibility criteria
Who can join
- 1. Male or female participants must be aged 18 years or older
- 2. Ability to comprehend the Patient Information Leaflet and to provide signed and dated informed consent.
- 3. Participants with an established diagnosis of Addison’s disease currently treated with immediate-release hydrocortisone as replacement therapy .
- 4. Participants on stable immediate-release hydrocortisone treatment for ≥ 4 weeks prior to enrolment.
- 5. Participants on a stable dose of fludrocortisone for ≥ 4 weeks prior to enrolment
- 6. Evidence of effective contraception for WOCBP* (see Appendix 11) *Women of childbearing potential (WOCBP) are eligible to participate if they are not pregnant, not breastfeeding and agree to adhere to the contraceptive guidance during the screening and treatment periods. Effective contraception should be maintained until treatment discontinuation. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. The effective methods of contraception are described in Appendix 11
- 7. In the Investigator’s opinion, able and willing to comply with all trial requirements.
What rules you out
- Participants aged < 18 years
- Conditions that would place the individual at increased risk or preclude the individual’s full compliance with or completion of the study – such as intellectual disability or cognitive impairment
- Patients who have difficulty understanding the required protocol and follow up instructions (e.g. language barriers)
- Participants with life expectancy of less than 6 months.
- Participants with a history of malabsorption and/or motility disorders due to risk of impaired cortisol exposure.
- Participants treated with agents that interfere with corticosteroid metabolism.
- Participants who have received intra-articular steroid injections within 2 months prior to the Screening Visit or for whom such injections are planned during the study.
- Participants who are prescribed inhaled or topical steroid preparations
- Participants with ongoing use of drugs which affect sleep - such as sedatives or antidepressants.
- Patients who have participated in another research trial involving an investigational product in the past 12 weeks.
- Ongoing habitual alcohol intake in excess of 20 units per week.
- Clinical or biochemical evidence of hepatic disease: elevated liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 times the upper limit of normal [ULN]).
- History of night-shift work in the previous two years
- Participants who intend to travel and cross a time zone of greater than ±3 hours within 1 week of the scheduled actigraphy and DLMO measurements.
- Participants with a known hypersensitivity to any of the components of the Efmody™ capsules.
- Pregnancy
- Breastfeeding Mothers
- Clinical or biochemical evidence of renal disease: serum creatinine level of >221 μmol/L (2.5 mg/dL) or calculated creatinine clearance of <25 mL/min.
- Participants who have type 1 diabetes or type 2 diabetes receiving regular insulin.
- Participants who have elective surgical procedures scheduled during the study.
- Current diagnosis of moderate to severe depression, bipolar disorder, eating disorders, schizophrenia or other psychosis. A past history of psychiatric disorder is not an exclusion criterion, provided the patient is currently well (not on psychoactive treatment) in the investigator’s judgement. Participants with psychiatric conditions that in the opinion of the Investigator would preclude participation in the study: such as severe depression, schizophrenia, eating disorders.
- Participants with an acute medical or surgical illness.
- History of significant medical co-morbidities which disrupt sleep (for example, obstructive sleep apnoea, congestive cardiac failure or restless leg syndrome)
- History of cataracts or other ophthalmologic conditions which could affect retina light perception.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.