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Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS

ConditionsMild Autonomous Cortisol Secretion (MACS)Autonomous Cortisol Secretion (ACS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

single-center, randomized, double-blind, placebo-controlled Phase 2 study to evaluate safety and efficacy of overnight metyrapone in patients with MACS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide written informed consent.

Stated willingness to comply with all study procedures and availability for the duration of the study.

Age ≥ 18 years

Diagnosed with MACS i. at least 2 abnormal post-dexamethasone cortisol results1 mg post-dexamethasone cortisol >1.8 mcg/dL or ii. 8 mg post-dexamethasone cortisol >1 mcg/dL b. Historical dexamethasone suppression test results can be used if performed within 24 months prior to enrollment.

Disqualifiers

Planned alternative therapy for MACS within 12 months after joining the study.

Current use of oral exogenous glucocorticoid therapy

Current use of opioid therapy >20 MME/day

Planned use of oral exogenous glucocorticoid therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metyrapone 250 mg Oral Tablets

    Drug

    Subjects will receive metyrapone beginning at 500 mg and titrating up to 1000 mg

  • Placebo

    Drug

    Subjects will receive placebo at 500 mg dose and titrated up to 1000 mg to match interventional arm and prevent unblinding

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: MetyraponeExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Glucocorticoid to androgen ratio

Glucocorticoid to androgen ratio will be calculated based on total glucocorticoids and total androgens measured through 25-steroid urine profiling.

Time frame
3 and 6 months
2

Delta salivary cortisone

Waking salivary cortisone and bedtime salivary cortisone will be assessed, and delta calculated.

Time frame
3 and 6 months

Secondary outcomes

1

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

The investigators will assess adverse events using CTCAE v4.0 at baseline and continuously.

Time frame
0-6 months
2

Change in body mass index (BMI)

The investigators will assess for change in the body mass index with metyrapone therapy.

Time frame
3 and 6 months
3

Adrenal insufficiency symptoms as assessed by the AddiQoL Survey

The investigators will administer AddiQoL Survey at baseline, 1 week after each dose titration, and at 3 and 6 months.

Time frame
Baseline, 1 week post dose titration, 3 and 6 months
4

Adrenal insufficiency as assessed through morning ACTH and cortisol measurements.

The investigators will measure ACTH and cortisol in the morning at baseline, 3 and 6 months to assess for biochemical adrenal insufficiency.

Time frame
baseline, 3, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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