Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT06035458
Eligibility Criteria:
Inclusion Criteria:
Anti-CGRP mAbs treated group (TC):
* Anti-CGRP mAbs naïve males and females;
* Aged between 18 and 50 years;
* Affected with migraine with or without aura \[4\];
* Planning to start a migraine preventive monotherapy with and satisfying the prescription criteria for Anti-CGRP mAbs erenumab, galcanezumab, and fremanezumab according to the Swiss reimbursement authorities (previous treatment with at least 2 migraine preventive therapies among beta-blockers, calcium antagonists, anticonvulsants and selective serotonin reuptake inhibitors SSRI must have been ineffective, contraindicated or not tolerated; mean number of monthly migraine days (MMD) in three consecutive months must be at least 8).
Control group, not treated with anti-CGRP mAbs (CG)
* Males and females
* Aged between 18 and 50 years;
* Affected with migraine with or without aura \[4\];
* Under no migraine preventive therapies;
* Never treated with / not planning to start on anti-CGRP mAbs
Exclusion Criteria:
* An ongoing treatment with one of the following drugs: protonic pump inhibitors, selective serotonin reuptake inhibitors (such as escitalopram, fluoxetine, paroxetine, sertraline), glitazones, anti-aromatase, anti-androgen medications, glucocorticoids; having ever received glucocorticoids at doses of ≥5 mg (or equivalent) for ≥3 months, anti-retroviral drugs, vitamin k inhibitors or bone antiresorptive therapy;
* An ongoing supplementation with calcium, vitamin D;
* Being affected with osteoporosis or previous unprovoked fractures at adult age;
* Being affected with significant comorbidities potentially interfering with bone metabolism including: type 1 or 2 diabetes; gastrointestinal malabsorption and/or chronic inflammatory bowel diseases; primary hyperparathyroidism; hyperthyroidism; prolonged immobilization; rheumatoid arthritis; chronic obstructive bronchopneumopathy; Cushing syndrome; any other relevant diseases according to the investigator's judgement;
* A history of drug or alcohol abuse, or illicit substances use;
* Hypogonadism;
* Menopause;
* Pregnancy or breastfeeding.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06035458
Study Brief:
Protocol Section:
NCT06035458