Migraine MedDRA version: 20.0 Level: LLT Classification code 10020739 Term: Hyperprolactinemia System Organ Class: 100000004860
Conditions
Interventions
Trade Name: Cabergolin Teva
Product Name: Cabergolin
Pharmaceutical Form: Tablet
INN or Proposed INN: CABERGOLINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: mg
Sponsors
Aarhus University Hospital, Department of Endocrinology
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Duration and intensity of headaches - Hospital contacts due to headache - Use of Selective serotonin agonists - Number of days with sickleave - PGIC (Patients global impression of change) measured on a numeric scale from 1-10 - Headache-associated impact (HIT-6 and MIDAS);Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Denmark
Contacts
Public ContactDepartment of Endorcrinology
Aarhus University Hospital
Outcome results
None listed