CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
Primary Purpose
Migraine Without Aura
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CGRP
Sponsored by
About this trial
This is an interventional other trial for Migraine Without Aura
Eligibility Criteria
Inclusion Criteria:
- Migraine without aura patients genotyped for the 12 newly idetified gene variants associated with migraine.
Exclusion Criteria:
- Other primary headache
- A history of cerebrovascular disease and other CNS- disease
- A history suggesting ischaemic heart disease
- Serious somatic and mental disease
- Hypo- or hypertension
- Abuse of alcohol or medicine (opioid analgesics).
- Pregnant or breastfeeding women.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Migraine patients with high genetic load
Migraine patients with low genetic load
Arm Description
CGRP intravenous infusion 1.5 microgram/min for 20 min
CGRP intravenous infusion 1.5 microgram/min for 20 min
Outcomes
Primary Outcome Measures
CGRP induced migraine attacks in patients with high and low genetic load
The difference in incidence of migraine-like attacks between patients with high genetic load and patients with low genetic load using verbal rating scale (VRS).
Secondary Outcome Measures
CGRP induced migraine attacks in patients with high and low genetic load
The difference in area under the curve (AUC) for headache intensity scores (0-12 hours)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01924052
Brief Title
CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
Official Title
CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesized that migraine without patients with many genetic loci associated with migraine (high genetic load) would be more sensitive and get provoked more migraine attacks by calcitonin gene-related peptide (CGRP) compared to patients with few genetic loci associated with migraine (low genetic load).
Detailed Description
Migraine is a very prevalent neurological disorder with a strong genetic factor. The common forms of migraine have a multifactorial and polygenic pattern of inheritance and genetics research is crucial for a deeper understanding of migraine mechanisms. Recently, 12 genetic loci have been identified to be associated with migraine with (MA) and without aura (MA) in four large genome-wide association studies (GWAS). The functional consequences of these genetic loci in humans are yet unknown.
Calcitonin gene-related peptide (CGRP) is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures. CGRP can induce migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway and CGRP antagonism is efficient in the treatment of migraine attacks. Also, a recent study has showed that intracellular accumulation of cAMP is crucial for the induction of migraine attacks. However, CGRP does not cause migraine attacks in familial hemiplegic migraine (FHM), an autosomal dominant subtype of MA.
The phenotype of the migraine inducing effects of CGRP might therefore be linked to some of the 12 genetic susceptibility loci that have been identified. One of the genetic loci (rs13208321) is located in a gene (FHL5) that is associated with the regulation of cAMP-responsive elements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Without Aura
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Migraine patients with high genetic load
Arm Type
Active Comparator
Arm Description
CGRP intravenous infusion 1.5 microgram/min for 20 min
Arm Title
Migraine patients with low genetic load
Arm Type
Active Comparator
Arm Description
CGRP intravenous infusion 1.5 microgram/min for 20 min
Intervention Type
Drug
Intervention Name(s)
CGRP
Other Intervention Name(s)
calcitonin-gene-related peptide
Intervention Description
Calcitonin-gene-related-peptide (CGRP)
Primary Outcome Measure Information:
Title
CGRP induced migraine attacks in patients with high and low genetic load
Description
The difference in incidence of migraine-like attacks between patients with high genetic load and patients with low genetic load using verbal rating scale (VRS).
Time Frame
Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP
Secondary Outcome Measure Information:
Title
CGRP induced migraine attacks in patients with high and low genetic load
Description
The difference in area under the curve (AUC) for headache intensity scores (0-12 hours)
Time Frame
Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Migraine without aura patients genotyped for the 12 newly idetified gene variants associated with migraine.
Exclusion Criteria:
Other primary headache
A history of cerebrovascular disease and other CNS- disease
A history suggesting ischaemic heart disease
Serious somatic and mental disease
Hypo- or hypertension
Abuse of alcohol or medicine (opioid analgesics).
Pregnant or breastfeeding women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Song Guo, MD
Organizational Affiliation
Danish Headache Center & Department of Neurology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
We'll reach out to this number within 24 hrs