Migraine With AuraNCT03143465
Pharmacologically Triggered Migraine Without Aura and Neuroimaging
A study testing Calcitonin Gene-Related Peptide and Sildenafil in people with Migraine With Aura, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Migraine is a highly disabling disorder affecting 14% of the general population Worldwide and ranked as the 6th most debilitating disease worldwide by the WHO. One of the most fundamental questions of migraine, which remains to be elucidated, is the mechanism behind the generation of migraine attacks. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine With Aura
- What is being tested?
- Calcitonin Gene-Related Peptide and Sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2016to May 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 50 years
- Weight: 50-100 kg
- Diagnosis of migraine without aura (patient group only)
- Attacks of migraine without aura at least once every second month (patient group only)
Who cannot join
- Inconsistent laterality of headache
- History or family history of migraine (healthy subject group only)
- Tension-type headache more than one day per month on average (healthy subject group only)
- Tension-type headache to such a degree that the episodic migraine diagnosis is no longer fulfilled
- Any other primary headache disorder
- Daily intake of medication (apart from oral contraceptives)
Show all 16Show fewer
- Intake of any medication less than 4 half-lives before study start
- Daily smoking
- Pregnant or breastfeeding women
- Headache 48 h prior to study day
- Hypertension on the study day (systolic BP>150 mmHg or diastolic BP> 100 mmHg)
- Hypotension on the study day (systolic BP<90 mmHg or diastolic BP<50 mmHg)
- History of any cardiovascular disease including cerebrovascular disease
- Any disorder, that is deemed ineligible for participation by the study physicians
- Contraindications of MRI
- No use of safe contraception (women of fertile age only)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center, University Hospital
Glostrup Municipality
About this study
Official title: MR-Angiografi (MRA) og MR-Spektroskopi (MRS) Hos Raske forsøgspersoner og Patienter Med migræne Uden Aura Provokeret Med Calcitonin Gen-relateret Peptid (CGRP) og Sildenafil
Migraine is a highly disabling disorder affecting 14% of the general population Worldwide and ranked as the 6th most debilitating disease worldwide by the WHO. One of the most fundamental questions of migraine, which remains to be elucidated, is the mechanism behind the generation of migraine attacks.
The investigators will use calcitonin gene-related peptide (CGRP) and sildenafil as pharmacological triggers of migraine, combined with advanced neuroimaging techniques, to investigate the attack initiating pathophysiology.
Read more
Both substances have previously been administered to healthy participants and migraine without aura patients, inducing headache and migraine-like-attacks.
The investigators hope to contribute with novelty to the current understanding of the migraine pathophysiology and development of more efficient treatment of migraine.
- Conditions
- Migraine With Aura
- Being tested
- Calcitonin Gene-Related Peptide, Sildenafil, Placebo
- Medical subject headings
- Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcitonin Gene-Related PeptideDrug
SildenafilDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CGRP | Experimental | Not described Receives: Drug: Calcitonin Gene-Related Peptide |
| Sildenafil | Experimental | Not described Receives: Drug: Sildenafil |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGRP and sildenafil induced headache and MRI changes
CGRP and sildenafil induced headache and MRI changes
Measured: 0- 12h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study startAug 2016
- Primary completionDec 2018
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Migraine With 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaira Younis, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143465
- Sponsor's protocol ID
- H-15019063
- Status last verified
- Feb 2019
- First submitted
- 4 May 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Younis S, Christensen CE, Toft NM, Soborg T, Amin FM, Hougaard A, Ashina M. Investigation of distinct molecular pathways in migraine induction using calcitonin gene-related peptide and sildenafil. Cephalalgia. 2019 Dec;39(14):1776-1788. doi: 10.1177/0333102419882474. Epub 2019 Nov 4.
PubMed 31684759Christensen CE, Younis S, Lindberg U, Boer VO, de Koning P, Petersen ET, Paulson OB, Larsson HBW, Amin FM, Ashina M. Ultra-high field MR angiography in human migraine models: a 3.0 T/7.0 T comparison study. J Headache Pain. 2019 May 6;20(1):48. doi: 10.1186/s10194-019-0996-x.
PubMed 31060491
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-Angiografi (MRA) og MR-Spektroskopi (MRS) Hos Raske forsøgspersoner og Patienter Med migræne Uden Aura Provokeret Med Calcitonin Gen-relateret Peptid (CGRP) og Sildenafil
- ClinicalTrials.gov ID
- NCT03143465
- Acronym / sponsor ID
- H-15019063
- Conditions
- Migraine With Aura
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- May 2019 (estimated)
- First posted
- 8 May 2017 (actual)
- 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.
Migraine is a highly disabling disorder affecting 14% of the general population Worldwide and ranked as the 6th most debilitating disease worldwide by the WHO. One of the most fundamental questions of migraine, which remains to be elucidated, is the mechanism behind the generation of migraine attacks.
The investigators will use calcitonin gene-related peptide (CGRP) and sildenafil as pharmacological triggers of migraine, combined with advanced neuroimaging techniques, to investigate the attack initiating pathophysiology.
Both substances have previously been administered to healthy participants and migraine without aura patients, inducing headache and migraine-like-attacks.
The investigators hope to contribute with novelty to the current understanding of the migraine pathophysiology and development of more efficient treatment of migraine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CGRP | Experimental | Drug: Calcitonin Gene-Related Peptide |
| Sildenafil | Experimental | Drug: Sildenafil |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 50 years
- Weight: 50-100 kg
- Diagnosis of migraine without aura (patient group only)
- Attacks of migraine without aura at least once every second month (patient group only)
Key exclusion criteria (16 listed)
- Inconsistent laterality of headache
- History or family history of migraine (healthy subject group only)
- Tension-type headache more than one day per month on average (healthy subject group only)
- Tension-type headache to such a degree that the episodic migraine diagnosis is no longer fulfilled
- Any other primary headache disorder
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 |
|---|---|---|
| Calcitonin Gene-Related Peptide | Drug | CGRP |
| Sildenafil | Drug | Sildenafil |
| Placebo | Drug | Placebo |
Primary outcome
CGRP and sildenafil induced headache and MRI changes
Time frame: 0- 12h
CGRP and sildenafil induced headache and MRI changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 31684759Younis S, Christensen CE, Toft NM, Soborg T, Amin FM, Hougaard A, Ashina M. Investigation of distinct molecular pathways in migraine induction using calcitonin gene-related peptide and sildenafil. Cephalalgia. 2019 Dec;39(14):1776-1788. doi: 10.1177/0333102419882474. Epub 2019 Nov 4.
- Derived from this study: PubMed 31060491Christensen CE, Younis S, Lindberg U, Boer VO, de Koning P, Petersen ET, Paulson OB, Larsson HBW, Amin FM, Ashina M. Ultra-high field MR angiography in human migraine models: a 3.0 T/7.0 T comparison study. J Headache Pain. 2019 May 6;20(1):48. doi: 10.1186/s10194-019-0996-x.
- Individual participant dataSharing planned: No
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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 Calcitonin Gene-Related Peptide and Sildenafil in people with Migraine With 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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 15 Feb 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 and sildenafil induced headache and MRI changes (time frame: 0- 12h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03143465, which also lists 2 linked publications.
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 15 Feb 2019.