Migraine Without AuraNCT02158221
PACAP Induced Migraine Attacks in Patients With High and Low Genetic Load
A study testing PACAP in people with Migraine Without Aura, run by Danish Headache Center at 1 site in Denmark.
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 PACAP compared to patients with few genetic loci associated with migraine (low genetic load). 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?
- PACAP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Dec 2014
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center & Department of Neurology
Copenhagen, Glostrup, 2600
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 PACAP 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 this genetic variant in humans are yet unknown.
PACAP is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures. PACAP can induce migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway. Also, a recent study has showed that intracellular accumulation of cAMP is crucial for the induction of migraine attacks.
The phenotype of the migraine inducing effects of PACAP might therefore be linked to some of the 12 genetic susceptibility loci that have been identified.
- Conditions
- Migraine Without Aura
- Being tested
- PACAP
- 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.
PACAPDrug
Also called Pituitary adenylate cyclase-activating polypeptide
Pituitary adenylate cyclase-activating polypeptide (PACAP)
| Study group | Role | What they receive |
|---|---|---|
| Migraine patients with high genetic load | Active comparator | PACAP intravenous infusion 1.5 microgram/min for 20 min Receives: Drug: PACAP |
| Migraine patients with low genetic load | Active comparator | PACAP intravenous infusion 1.5 microgram/min for 20 min Receives: Drug: PACAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of migraine attacks induced by PACAP in patients with high and low genetic load.
The difference in incidence of migraine-like attacks after PACAP between patients with and without 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 PACAP
Secondary outcomes (1)
Incidence of headache induced by PACAP in patients with high and low genetic load.
The difference in area under the curve (AUC) for headache intensity scores (0-12 hours) after infusion of PACAP
Measured: Change from baseline in headache intensity at 12 hours after the start of infusion of PACAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionDec 2014
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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158221
- Sponsor's protocol ID
- H-2-2013-043
- Status last verified
- Feb 2015
- First submitted
- 5 Jun 2014
- Last updated
- 10 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PACAP Induced Migraine Attacks in Patients With High and Low Genetic Load
- ClinicalTrials.gov ID
- NCT02158221
- Acronym / sponsor ID
- H-2-2013-043
- Conditions
- Migraine Without Aura
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Jun 2014 (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 PACAP 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 this genetic variant in humans are yet unknown.
PACAP is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures. PACAP can induce migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway. Also, a recent study has showed that intracellular accumulation of cAMP is crucial for the induction of migraine attacks.
The phenotype of the migraine inducing effects of PACAP might therefore be linked to some of the 12 genetic susceptibility loci that have been identified.
Study design
- 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: PACAPPACAP intravenous infusion 1.5 microgram/min for 20 min |
| Migraine patients with low genetic load | Active comparator | Drug: PACAPPACAP 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 |
|---|---|---|
| PACAPAlso: Pituitary adenylate cyclase-activating polypeptidePituitary adenylate cyclase-activating polypeptide (PACAP) | Drug | Migraine patients with high genetic load, Migraine patients with low genetic load |
Primary outcome
Incidence of migraine attacks induced by PACAP 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 PACAP
The difference in incidence of migraine-like attacks after PACAP between patients with and without high genetic load and patients with low genetic load using verbal rating scale (VRS).
1 secondary outcome
Incidence of headache induced by PACAP 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 PACAP
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 10 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACAP in people with Migraine Without Aura, run by Danish Headache Center at 1 site in Denmark.
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 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Incidence of migraine attacks induced by PACAP 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 PACAP). 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 10 Feb 2015.