Cabergoline as a Preventive Treatment for Chronic Migraine
Primary Purpose
Migraine
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cabergoline 0.5 MG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- Migraine and more than 6 days with headache every months
Exclusion Criteria:
- Cardiac valve disease
- Hypertension
- Psychiatric disease
- Treated with dopamine receptor agonists, dopamin receptor antagonists, macrolides and itraconazole
- pregnant or breastfeeding
Sites / Locations
- Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cabergoline
Control
Arm Description
Outcomes
Primary Outcome Measures
A change in days with headache in patients with chronic migraine
Based on a headache diary
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05525611
Brief Title
Cabergoline as a Preventive Treatment for Chronic Migraine
Official Title
Cabergoline as a Preventive Treatment for Chronic Migraine: an Investigator-Initiated, Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Headache disorders constitute a major global disease burden, and migraine - with a one-year prevalence of 15 % - is the sixth most disabling condition. Though a common disease, the pathogenesis is still unclear. Thus, the treatments have different mechanisms of action and preventive treatments are only effective in approximately 50% of chronic migraine patients. Recent evidence from mice models and a study of prolactine-associated headaches have indicated that dopamine agonists such as cabergoline might be used as a treatment of migraine.
The aim of this study is to test the hypothesis that the dopamine agonist cabergoline can be used as a treatment of chronic migraine. A randomized controlled trial of 24 patients with chronic migraine will be conducted, comparing cabergoline to placebo as an add-on medication to the patients' migraine treatment over a 12 weeks period. The primary outcome is change in migraine frequency, but also headache-related hospital contacts, and quality of life as well as prolactin levels and biomarkers of the pituitary-gonadal-axis. The results of the study will help understand the pathogenesis of migraine and might also introduce a more effective and affordable preventive migraine treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, placebo-controlled parallel study with a 12 weeks duration.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cabergoline
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cabergoline 0.5 MG
Intervention Description
Cabergoline 0.5 mg once a week in 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo once a week in 12 weeks
Primary Outcome Measure Information:
Title
A change in days with headache in patients with chronic migraine
Description
Based on a headache diary
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Migraine and more than 6 days with headache every months
Exclusion Criteria:
Cardiac valve disease
Hypertension
Psychiatric disease
Treated with dopamine receptor agonists, dopamin receptor antagonists, macrolides and itraconazole
pregnant or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Astrid Hjelholt, MD, PhD
Phone
+4524800664
Email
ajh@clin.au.dk
Facility Information:
Facility Name
Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital
City
Aarhus N
State/Province
Region Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid Hjelholt, MD, PhD
Phone
+4524800664
Email
ajh@clin.au.dk
12. IPD Sharing Statement
Learn more about this trial
Cabergoline as a Preventive Treatment for Chronic Migraine
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