CABERGOLINE for Episodic migraine | Migraine

Inclusion criteria

• {"criterion_text":"- Episodic migraine with or without aura as defined by ICHD, 3rd edition, present for at least 12 months\n- 4–14 MMD in the last 3 months prior to inclusion\n- Male or female subjects ≥18 years of age\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- < 4 MMD or ≥ 15 MMD during the baseline period\n- Other common primary headache types (e.g. tension-type headache) if attacks are frequent (present on an average of >1 day/month and >12 days/year)\n- Changes in concomitant migraine-specific treatment within the 3 months prior to inclusion, or any planned adjustments to such treatment during the study period\n- History of pulmonary, retroperitoneal, or pericardial disorders, including heart valve disease\n- Severe untreated hypertension\n- Psychiatric disorders requiring pharmacological treatment\n- Chronic migraine (≥15 headache days per month)\n- Concurrent participation in another clinical trial that, in the judgement of the investigator, may interfere with the conduct or outcomes of the present study\n- Use of drugs with dopamine antagonistic or agonistic properties\n- Women of child-bearing potential (i.e. not chemically or surgically sterilized, or not postmeno-pausal) and male participants with partners of child-bearing potential, who are unwilling to use a medically accepted method of contraception, considered reliable by the investigator, from signing of informed consent and throughout the study\n- Women who are breast-feeding\n- Known hypersensitivity or allergy to compounds similar to the investigational medicinal product\n- Inability, in the opinion of the investigator, to understand or comply with study medication or procedures, or any condition which, in the investigator’s judgement, may render the subject unable to complete the study\n- Presumed medication-overuse headache (MOH)\n- Trigeminal autonomic cephalalgias and neuralgias\n- Secondary headache conditions\n- Women who have a positive pregnancy test at randomization"}

Primary endpoints

• {"endpoint_text":"- Change in MMD from baseline to the end of the 12-week double-blind phase. Migraine days are defined according to ICHD-3 criteria or the use of migraine-specific acute medication, recorded in a daily, electronic diary.","definition_or_measurement_approach":"Change in monthly migraine days (MMD) from baseline to end of 12-week double-blind phase; migraine days defined by ICHD-3 criteria or use of migraine-specific acute medication, recorded in a daily electronic headache diary."}

Secondary endpoints

• {"endpoint_text":"- Change in MMD from baseline to the last four weeks of the double-blind treatment phase.\n- Proportion of participants achieving ≥50% reduction in MMD during the last four weeks of the 12-week double-blind treatment phase.\n- Change in number of moderate/severe headache days from baseline to the last four weeks of the double-blind treatment phase.\n- Proportion of attacks classified as mild, moderate, or severe at the last four weeks of the double-blind treatment phase.\n- Change in number of days with use of acute migraine-specific medication from baseline to the last four weeks of the double-blind treatment phase.\n- Change in MIDAS, HIT-6 and WPAI scores from baseline to the last four weeks of the double-blind treatment phase.\n- PGIC score at the end of the double-blind treatment phases.\n- Change in MMD, proportion of participants achieving ≥50% reduction in MMD, number of moderate/severe headache days, acute medication use, and patient-reported outcomes (HIT-6, MIDAS, WPAI, and PGIC) assessed from baseline and from the last four weeks of the double-blind phase to the last four weeks of the open-label phase.\n- Change in MMD, proportion of participants achieving ≥50% reduction in MMD, number of moderate/severe headache days, acute medication use, and patient-reported outcomes (HIT-6, MIDAS, WPAI, and PGIC) from baseline to the last four weeks of the double-blind phase.\n- Change in MMD, proportion of participants achieving ≥50% reduction in MMD, number of moderate/severe headache days, acute medication use, and patient-reported outcomes (HIT-6, MIDAS, WPAI, and PGIC) from baseline to the last four weeks of the double-blind phase.\n- Incidence, severity, and type of AEs and SAEs during the trial.\n- Change in LDL-C, HDL-C, total cholesterol, triglycerides, HbA1c, FSH, LH, estrogen/testosterone, and hs-CRP from baseline to the end of the double-blind and open-label treatment phases.\n- Change in serum prolactin levels from baseline to the end of the double-blind and open-label treatment phases.\n- Genotyping of all participants for variants in the prolactin receptor and dopaminergic pathways previously associated with migraine and drug response.\n- Stratified analyses of efficacy and safety outcomes by sex, menopausal status, aura, presence of dopaminergic symptoms, and number of prior preventive treatments.\n- Estimation of cost per responder and cost per QALY gained. This analysis will be descriptive and exploratory.","definition_or_measurement_approach":"Endpoints measured using electronic headache diary (for MMD and headache severity), responder analysis (≥50% MMD reduction), patient-reported outcome instruments MIDAS, HIT-6, WPAI, PGIC, safety reporting of AEs/SAEs, laboratory measures (lipids, HbA1c, hormones, hs-CRP), serum prolactin assays, genotyping for specified variants, and descriptive health economic analysis (cost per responder, cost per QALY). Timing often refers to last four weeks of treatment phases or baseline comparisons as specified."}

Methods

• Use of recruitment materials (document titles indicate K2_Recruitment material digital version Da and digital flyer DA) — digital flyer targeted to potential participants (Danish language).
• Webinar slides (K2_Recruitment material webinar slides) — educational/awareness webinar as recruitment channel.
• Formal recruitment arrangements documents (K1_Recruitment arrangements) — site-level recruitment processes (Denmark).

Denmark

Earliest CTIS Part Ii Submission Date

24-10-2025

Latest Decision Or Authorization Date

07-11-2025

Processing Time Days

14

Number Of Sites

1

Number Of Participants

150

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Regionsapoteket Midtjylland","duties_or_roles":"[14]","organisation_type":"Health care"}
• {"country":"Denmark","full_name":"Glostrup Apotek v/Kristian Ostergaard Nielsen","duties_or_roles":"[14]","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"[1,8,9]","organisation_type":"Educational Institution"}