MigraineNCT04452929
The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients
A study testing Erenumab, Calcitonin gene-related peptide and Cilostazol in people with Migraine and Migraine Without Aura, run by Danish Headache Center at 1 site in Denmark.
Trial summary
A randomized, double-blind, placebo-controlled, parallel study to investigate the effect of erenumab in calcitonin-gene related peptide and cilostazol experimental models of migraine in humans. Followed by a 6-month open-label extension. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine, Migraine Without Aura, Migraine With Aura
- What is being tested?
- Erenumab, Calcitonin gene-related peptide and Cilostazol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Jul 2020to Jul 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with migraine with or without aura according to the International Classification of Headache Disorders with a frequency of ≥4 migraine days per month
- 50-100 kg weight
- Participants of childbearing potential must use safe contraception (birth control) or be sexually abstinent
Who cannot join
- Any other primary headache disorder according to the International Classification of Headache Disorders except for tension-type headache
- Any secondary headache disorder according to the International Classification of Headache Disorders
- Migraine attack during the preceding 48 hours on provocation day
- Headache during the preceding 24 hours on provocation day
- Treatment with monoclonal antibodies or participation in clinical trials with monoclonal antibodies during the preceding year
- Daily consumption of any other drug/medication than oral contraception (birth control)
Show all 11Show fewer
- Consumption of any other drug/medication later than four times the plasma half-time of the drug on provocation day except for oral contraception
- Pregnant or active breastfeeding participants
- Any cardiovascular diseases including cerebrovascular disorders
- Information in patient history or during physical examination indicating psychiatric disorders or substance abuse
- Information in patient history or during physical examination that the screening physician deems relevant for participation in the study
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Headache Center
Glostrup Municipality, 2600
Thien P Do, MD, 004541414117, tdoo0001@regionh.dk
Messoud Ashina, MD, PhD, DMSc
About this study
A randomized, double-blind, placebo-controlled, parallel study to investigate the effect of erenumab in calcitonin-gene related peptide and cilostazol experimental models of migraine in humans. Followed by a 6-month open-label extension.
- Conditions
- Migraine, Migraine Without Aura, Migraine With Aura
- Being tested
- Erenumab, Placebo, Calcitonin gene-related peptide, Cilostazol
- Medical subject headings
- Migraine Disorders, Migraine without Aura, Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErenumabDrug
Also called Aimovig®
Subcutaneous injection of 140 mg erenumab.
PlaceboDrug
Also called Saline placebo
Subcutaneous injection of saline placebo.
Calcitonin gene-related peptideDrug
Intravenous infusion of 1.5ug/min calcitonin gene-related peptide over 20 minutes.
CilostazolDrug
Oral intake of 200 mg cilostazol.
| Study group | Role | What they receive |
|---|---|---|
| Randomized treatment phase: Erenumab | Active comparator | Erenumab 140 mg single subcutaneous injection at baseline Receives: Drug: Erenumab; Drug: Calcitonin gene-related peptide; Drug: Cilostazol |
| Randomized treatment phase: Placebo | Placebo comparator | Saline placebo single subcutaneous injection at baseline Receives: Drug: Placebo; Drug: Calcitonin gene-related peptide; Drug: Cilostazol |
| Open-label extension treatment phase: Erenumab | Other | Erenumab 140 mg monthly subcutaneous injection for six months after completion of the randomized, double-blinded, placebo-controlled study phase during the open-label extension Receives: Drug: Erenumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine-like attack
The incidence of migraine-like attack after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo.
A migraine-like attack is defined attack fulfilling either (i) or (ii):
(i) Headache fulfilling criteria C and D for migraine without aura according to the International Headache Society criteria: C. Headache has at least two of the following characteristics: unilateral location; pulsating quality; moderate or severe pain intensity (moderate to severe pain intensity is considered ≥4 on verbal rating scale); aggravation by cough (in-hospital phase) or causing avoidance of routine physical activity (out-hospital phase); D. During headache at least one of the following: nausea and/or vomiting; photophobia and phonophobia; and (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).
Measured: Before (-5 min) and after administration of (+12 hours) of experimental trigger
Secondary outcomes (11)
Headache intensity
Change in headache intensity after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo.
Headache intensity scores are measured by a numerical rating scale (NRS). It is a verbally declared scale from 0 to 10, where 0 is no pain; 10 is the worst pain imaginable.
Measured: Before (-5 min) and after administration of (+12 hours) of experimental trigger
Hemodynamics (superficial temporal artery)
Change in diameter (mm) of superficial temporal artery after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo.
Measured: Before (-5 min) and after administration of (+90 minutes) of experimental trigger
Hemodynamics (radial artery)
Change in diameter (mm) of radial artery after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo.
Measured: Before (-5 min) and after administration of (+90 minutes) of experimental trigger
Neuropeptide plasma concentrations (CGRP)
- Change in plasma concentrations of calcitonin gene-related peptide (CGRP) after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo.
- Change in plasma concentrations of calcitonin gene-related peptide during the open-label treatment phase.
Measured: (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase
Neuropeptide plasma concentrations (VIP)
- Change in plasma concentrations of vasoactive intestinal peptide (VIP) after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo.
- Change in plasma concentrations of vasoactive intestinal peptide (VIP) during the open-label treatment phase.
Measured: (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase
Neuropeptide plasma concentrations (PACAP)
- Change in plasma concentrations of pituitary adenylate cyclase-activating peptide (PACAP) after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo.
- Change in plasma concentrations of pituitary adenylate cyclase-activating peptide (PACAP) during the open-label treatment phase.
Measured: (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase
Facial flushing
Change in facial skin flushing after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo.
Measured: Before (-5 min) and after administration of (+90 minutes) of experimental trigger
Facial temperature
Change in facial temperature after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo.
Measured: Before (-5 min) and after administration of (+90 minutes) of experimental trigger
Headache day
Change in number of headache days per month after administration of erenumab from baseline compared to the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase.
Measured: Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase
Migraine day
Change in number of migraine days per month after administration of erenumab from baseline compared to the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase.
Measured: Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase
≥50% responder rate
Proportion of participants with a ≥50% reduction in number of migraine days per month after administration of erenumab from baseline compared to the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase.
Measured: Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start22 Jul 2020
- Primary completionFeb 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled, parallel study followed by a 6-month open-label extension.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Messoud Ashina, Danish Headache Center
- Investigators
- Thien P Do, MD, Study director, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452929
- Sponsor's protocol ID
- CGRP2020
- Status last verified
- Oct 2020
- First submitted
- 22 Jun 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients
- ClinicalTrials.gov ID
- NCT04452929
- Acronym / sponsor ID
- CGRP2020
- Conditions
- Migraine, Migraine Without Aura, Migraine With Aura
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 1 Jul 2020 (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.
A randomized, double-blind, placebo-controlled, parallel study to investigate the effect of erenumab in calcitonin-gene related peptide and cilostazol experimental models of migraine in humans. Followed by a 6-month open-label extension.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, double-blinded, placebo-controlled, parallel study followed by a 6-month open-label extension.
| Arm | Type | Receives |
|---|---|---|
| Randomized treatment phase: Erenumab | Active comparator | Drug: Erenumab, Drug: Calcitonin gene-related peptide, Drug: CilostazolErenumab 140 mg single subcutaneous injection at baseline |
| Randomized treatment phase: Placebo | Placebo comparator | Drug: Placebo, Drug: Calcitonin gene-related peptide, Drug: CilostazolSaline placebo single subcutaneous injection at baseline |
| Open-label extension treatment phase: Erenumab | Other | Drug: ErenumabErenumab 140 mg monthly subcutaneous injection for six months after completion of the randomized, double-blinded, placebo-controlled study phase during the open-label extension |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with migraine with or without aura according to the International Classification of Headache Disorders with a frequency of ≥4 migraine days per month
- 50-100 kg weight
- Participants of childbearing potential must use safe contraception (birth control) or be sexually abstinent
Key exclusion criteria (11 listed)
- Any other primary headache disorder according to the International Classification of Headache Disorders except for tension-type headache
- Any secondary headache disorder according to the International Classification of Headache Disorders
- Migraine attack during the preceding 48 hours on provocation day
- Headache during the preceding 24 hours on provocation day
- Treatment with monoclonal antibodies or participation in clinical trials with monoclonal antibodies during the preceding year
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 |
|---|---|---|
| ErenumabAlso: Aimovig®Subcutaneous injection of 140 mg erenumab. | Drug | Open-label extension treatment phase: Erenumab, Randomized treatment phase: Erenumab |
| PlaceboAlso: Saline placeboSubcutaneous injection of saline placebo. | Drug | Randomized treatment phase: Placebo |
| Calcitonin gene-related peptideIntravenous infusion of 1.5ug/min calcitonin gene-related peptide over 20 minutes. | Drug | Randomized treatment phase: Erenumab, Randomized treatment phase: Placebo |
| CilostazolOral intake of 200 mg cilostazol. | Drug | Randomized treatment phase: Erenumab, Randomized treatment phase: Placebo |
Primary outcome
Migraine-like attack
Time frame: Before (-5 min) and after administration of (+12 hours) of experimental trigger
The incidence of migraine-like attack after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo. A migraine-like attack is defined attack fulfilling either (i) or (ii): (i) Headache fulfilling criteria C and D for migraine without aura according to the International Headache Society criteria: C. Headache has at least two of the following characteristics: unilateral location; pulsating quality; moderate or severe pain intensity (moderate to severe pain intensity is considered ≥4 on verbal rating scale); aggravation by cough (in-hospital phase) or causing avoidance of routine physical activity (out-hospital phase); D. During headache at least one of the following: nausea and/or vomiting; photophobia and phonophobia; and (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).
11 secondary outcomes
Headache intensity
Time frame: Before (-5 min) and after administration of (+12 hours) of experimental trigger
Hemodynamics (superficial temporal artery)
Time frame: Before (-5 min) and after administration of (+90 minutes) of experimental trigger
Hemodynamics (radial artery)
Time frame: Before (-5 min) and after administration of (+90 minutes) of experimental trigger
Neuropeptide plasma concentrations (CGRP)
Time frame: (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase
Neuropeptide plasma concentrations (VIP)
Time frame: (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase
Neuropeptide plasma concentrations (PACAP)
Time frame: (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase
Facial flushing
Time frame: Before (-5 min) and after administration of (+90 minutes) of experimental trigger
Facial temperature
Time frame: Before (-5 min) and after administration of (+90 minutes) of experimental trigger
Headache day
Time frame: Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase
Migraine day
Time frame: Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase
≥50% responder rate
Time frame: Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- 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.
Thien P Do, MD 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 Erenumab, Calcitonin gene-related peptide and Cilostazol in people with Migraine and 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 3 inclusion and 11 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 8 Oct 2020. 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?
Contact Thien P Do, MD (004541414117, tdoo0001@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine-like attack (time frame: Before (-5 min) and after administration of (+12 hours) of experimental trigger). 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 8 Oct 2020.