Cabergoline as a Preventive Treatment for Chronic Migraine
Phase 1
- Conditions
- MigraineMedDRA version: 20.0Level: LLTClassification code 10020739Term: HyperprolactinemiaSystem Organ Class: 100000004860Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2021-005579-38-DK
- Lead Sponsor
- Aarhus University Hospital, Department of Endocrinology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- Migraine and more than six days of headache /month
- Age = 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
Exclusion Criteria
- Known or suspected heart valve disease
- Severe, untreated hypertension
- Psychiatric disease requiring pharmacological treatment
- Treatment with dopamine receptor agonists
- Treatment with other medicine with known interaction with cabergoline
- Pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the effect of Cabergoline in patients with migraine;Secondary Objective: Not applicable;Primary end point(s): Reduction in number of days with headache;Timepoint(s) of evaluation of this end point: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Duration and intensity of headaches<br>- Hospital contacts due to headache<br>- Use of Selective serotonin agonists<br>- Number of days with sickleave<br>- PGIC (Patients global impression of change) measured on a numeric scale from 1-10<br>- Headache-associated impact (HIT-6 and MIDAS);Timepoint(s) of evaluation of this end point: 12 weeks