Migraine Without AuraNCT01924052
CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
A study testing CGRP in people with Migraine Without Aura, run by Danish Headache Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- CGRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Migraine without aura patients genotyped for the 12 newly idetified gene variants associated with migraine.
Who cannot join
- 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.
About this study
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).
Read the 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.
- Conditions
- Migraine Without Aura
- Being tested
- CGRP
- Medical subject headings
- Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGRPDrug
Also called calcitonin-gene-related peptide
Calcitonin-gene-related-peptide (CGRP)
| Study group | Role | What they receive |
|---|---|---|
| Migraine patients with high genetic load | Active comparator | CGRP intravenous infusion 1.5 microgram/min for 20 min Receives: Drug: CGRP |
| Migraine patients with low genetic load | Active comparator | CGRP intravenous infusion 1.5 microgram/min for 20 min Receives: Drug: CGRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP
Secondary outcomes (1)
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)
Measured: Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Guo, Danish Headache Center
- Investigators
- Song Guo, MD, Principal investigator, Danish Headache Center & Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924052
- Sponsor's protocol ID
- H-2-2011-141
- Status last verified
- Jul 2022
- First submitted
- 10 Aug 2013
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
- ClinicalTrials.gov ID
- NCT01924052
- Acronym / sponsor ID
- H-2-2011-141
- Conditions
- Migraine Without Aura
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraine patients with high genetic load | Active comparator | Drug: CGRPCGRP intravenous infusion 1.5 microgram/min for 20 min |
| Migraine patients with low genetic load | Active comparator | Drug: CGRPCGRP intravenous infusion 1.5 microgram/min for 20 min |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Migraine without aura patients genotyped for the 12 newly idetified gene variants associated with migraine.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGRPAlso: calcitonin-gene-related peptideCalcitonin-gene-related-peptide (CGRP) | Drug | Migraine patients with high genetic load, Migraine patients with low genetic load |
Primary outcome
CGRP induced migraine attacks in patients with high and low genetic load
Time frame: Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP
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).
1 secondary outcome
CGRP induced migraine attacks in patients with high and low genetic load
Time frame: Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
Related trials for Migraine Without Aura
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
RecruitingPhase 3
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Pediatric Migraine
RecruitingPhase 3
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Acute Treatment of Migraine
RecruitingPhase 1
A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department
Migraine, Migraine Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Song Guo, MD principal investigator
Danish Headache Center & Department of Neurology
Questions about this trial
What is this clinical trial studying?
A study testing CGRP in people with Migraine Without Aura, run by Danish Headache Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGRP induced migraine attacks in patients with high and low genetic load (time frame: Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.