search
Back to results

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
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 1, 2022
Last Updated
November 1, 2022
Sponsor
University of Aarhus
search

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

We'll reach out to this number within 24 hrs