MigraineNCT03481400
CGRP-induced Migraine Attacks in Patients Who Have Tried Anti-CGRP Monoclonal Antibody Treatment
A study testing Calcitonin Gene-Related Peptide in people with Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
The investigators aim to investigate the incidence of migraine attacks after calcitonin gene-related peptide (CGRP) infusion in patients who have tried anti-CGRP monoclonal antibody treatment for the prevention of migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Calcitonin Gene-Related Peptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2016to Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of migraine according to the international classification of headache disorders version 3-beta
- Subject has tried anti-CGRP antibodies for migraine
- Women of childbearing potential are on safe contraception
Who cannot join
- Women of childbearing potential who do not use contraception. Includes non-hysterectomized women who have not been menopausal for at least two years. Safe contraception includes condoms, intrauterine devices, p-pills, surgical sterilization or gestagen injections.
- Daily drug intake apart from contraceptives and preventive medication for migraine.
- Ingestion of any drug 4 half-lifes before study start apart from contraceptives.
- Pregnant or breast-feeding women
- Migraine on the study day or less than 48 hours before CGRP infusion.
- A history of cardiovascular and/or cerebrovascular disease
Show all 10Show fewer
- Systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg on study day.
- Systolic blood pressure <90 mmHg and/or diastolic blood pressure < 50 mmHg on study day.
- A history of mental illness
- A history of any illness or condition that is deemed relevant for participation by the investigator.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Headache Center, Rigshospitalet Glostrup
Copenhagen, Glostrup, 2600
Casper E Christensen, MD, 38632027, casper.emil.christensen.03@regionh.dk
Samaira Younis, MD, 38633863, samaira.younis.01@regionh.dk
About this study
Official title: Provoked Migraine Attacks With Calcitonin Gene-related Peptide (CGRP) in Patients Who Have Tried Preventive Treatment With Anti-CGRP Monoclonal Antibodies.
The investigators aim to investigate the incidence of migraine attacks after calcitonin gene-related peptide (CGRP) infusion in patients who have tried anti-CGRP monoclonal antibody treatment for the prevention of migraine.
Read the detailed description
Calcitonin gene-related peptide (CGRP) plays a role in migraine pathophysiology. Infusions of CGRP can trigger migraine-like attacks in migraine patients and antibodies against CGRP or the CGRP receptor significantly reduces the number of migraine days per month when administered regularly. Some patients however, do not experience migraine attack after CGRP infusion, and some do not experience migraine reduction with antibodies. The underlying mechanisms of these effects are largely unknown.
The purpose of this study is to examine CGRP-induced migraine in patients who have evaluated the efficacy of anti-CGRP monoclonal antibody treatment for migraine using a purpose-developed standardized interview. The investigators will use a double-blind, placebo-controlled crossover study design to examine migraine susceptibility to CGRP in these patients.
- Conditions
- Migraine
- Being tested
- Calcitonin Gene-Related Peptide, Placebo
- Keywords
- Calcitonin gene-related peptide
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcitonin Gene-Related PeptideDrug
Also called CGRP
Calcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins)
PlaceboOther
Isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| Calcitonin gene-related peptide | Experimental | Calcitonin gene-related peptide infusion (1.5 micrograms/min for 20 mins) Receives: Drug: Calcitonin Gene-Related Peptide |
| Placebo | Experimental | Infusion with placebo (isotonic saline) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of migraine
Incidence of migraine after CGRP infusion
Measured: From 0 to 12 hours after CGRP infusion
Area under the curve of headache intensity
Area under the curve of headache intensity from 0-90 min and 90 min-12 hours post infusion
Measured: From 0 to 90 minutes after infusion and from 90 minutes to 12 hours after infusion
Secondary outcomes (2)
Heart rate
Heart rate (beats per minute)
Measured: From 0 to 90 minutes after infusion
Blood pressure
Blood pressure (millimeter of mercury)
Measured: From 0 to 90 minutes after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study startJul 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo-controlled, crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casper Emil Christensen, Danish Headache Center
- Investigators
- Messoud Ashina, prof., Study director, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481400
- Sponsor's protocol ID
- H-16014580
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christensen CE, Younis S, Deen M, Khan S, Ghanizada H, Ashina M. Migraine induction with calcitonin gene-related peptide in patients from erenumab trials. J Headache Pain. 2018 Nov 8;19(1):105. doi: 10.1186/s10194-018-0927-2.
PubMed 30409109
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provoked Migraine Attacks With Calcitonin Gene-related Peptide (CGRP) in Patients Who Have Tried Preventive Treatment With Anti-CGRP Monoclonal Antibodies.
- ClinicalTrials.gov ID
- NCT03481400
- Acronym / sponsor ID
- H-16014580
- Conditions
- Migraine
- Keywords
- Calcitonin gene-related peptide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 29 Mar 2018 (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.
The investigators aim to investigate the incidence of migraine attacks after calcitonin gene-related peptide (CGRP) infusion in patients who have tried anti-CGRP monoclonal antibody treatment for the prevention of migraine.
Detailed description
Calcitonin gene-related peptide (CGRP) plays a role in migraine pathophysiology. Infusions of CGRP can trigger migraine-like attacks in migraine patients and antibodies against CGRP or the CGRP receptor significantly reduces the number of migraine days per month when administered regularly. Some patients however, do not experience migraine attack after CGRP infusion, and some do not experience migraine reduction with antibodies. The underlying mechanisms of these effects are largely unknown.
The purpose of this study is to examine CGRP-induced migraine in patients who have evaluated the efficacy of anti-CGRP monoclonal antibody treatment for migraine using a purpose-developed standardized interview. The investigators will use a double-blind, placebo-controlled crossover study design to examine migraine susceptibility to CGRP in these patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Placebo-controlled, crossover design.
| Arm | Type | Receives |
|---|---|---|
| Calcitonin gene-related peptide | Experimental | Drug: Calcitonin Gene-Related PeptideCalcitonin gene-related peptide infusion (1.5 micrograms/min for 20 mins) |
| Placebo | Experimental | Other: PlaceboInfusion with placebo (isotonic saline) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of migraine according to the international classification of headache disorders version 3-beta
- Subject has tried anti-CGRP antibodies for migraine
- Women of childbearing potential are on safe contraception
Key exclusion criteria (10 listed)
- Women of childbearing potential who do not use contraception. Includes non-hysterectomized women who have not been menopausal for at least two years. Safe contraception includes condoms, intrauterine devices, p-pills, surgical sterilization or gestagen injections.
- Daily drug intake apart from contraceptives and preventive medication for migraine.
- Ingestion of any drug 4 half-lifes before study start apart from contraceptives.
- Pregnant or breast-feeding women
- Migraine on the study day or less than 48 hours before CGRP infusion.
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 PeptideAlso: CGRPCalcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins) | Drug | Calcitonin gene-related peptide |
| PlaceboIsotonic saline | Other | Placebo |
Primary outcome
Incidence of migraine
Time frame: From 0 to 12 hours after CGRP infusion
Incidence of migraine after CGRP infusion
Area under the curve of headache intensity
Time frame: From 0 to 90 minutes after infusion and from 90 minutes to 12 hours after infusion
Area under the curve of headache intensity from 0-90 min and 90 min-12 hours post infusion
2 secondary outcomes
Heart rate
Time frame: From 0 to 90 minutes after infusion
Blood pressure
Time frame: From 0 to 90 minutes after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 30409109Christensen CE, Younis S, Deen M, Khan S, Ghanizada H, Ashina M. Migraine induction with calcitonin gene-related peptide in patients from erenumab trials. J Headache Pain. 2018 Nov 8;19(1):105. doi: 10.1186/s10194-018-0927-2.
- 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.
Messoud Ashina, prof. study director
Danish Headache Center
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 in people with Migraine, 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 3 inclusion and 10 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 29 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Casper E Christensen, MD (38632027, casper.emil.christensen.03@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of migraine (time frame: From 0 to 12 hours after CGRP infusion). The study lists 2 primary outcomes in all. 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 NCT03481400, which also lists 1 linked publication.
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 29 Mar 2018.