Cluster HeadacheNCT02466334
CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
A study testing Calcitonin-Gene Related Peptide in people with Cluster Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
It has previously been shown that nitroglycerine induces cluster headache attacks in episodic cluster headache patients (ECH patients) in bouts but not in remission phase. Furthermore, plasma concentrations of calcitonin gene-related peptide (CGRP) have been shown to be significantly higher during, but not before and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cluster Headache
- 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
- 37 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2015to Dec 2018
- 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
- Fulfillment of IHS criteria for cluster headache either chronic or episodic
- Patients in bouts 1-32 attacks per week
- Patients in remission minimum of 1 month remission time
- fertile women must use safe contraception
Who cannot join
- All other primary types of headache
- headache 8 hours or less before study day begins
- pregnant or lactating women
- any history or clinical sigs of hyper/hypotension, heart disease, mental disorder, substance abuse, or other illness deemed relevant by the medical doctor assessing the patient
Trial locations and contacts
1 site in 1 country.
About this study
It has previously been shown that nitroglycerine induces cluster headache attacks in episodic cluster headache patients (ECH patients) in bouts but not in remission phase. Furthermore, plasma concentrations of calcitonin gene-related peptide (CGRP) have been shown to be significantly higher during, but not before and after, an attack.
The attack appears around 20-40 min after nitroglycerine infusion with vasodilatation. During this latency period preceding the attack, no increase in CGRP plasma concentrations is seen. CGRP induces migraine attacks in 65% of migraine patients, and CGRP antagonists as well as monoclonal antibodies against CGRP are effective in migraine treatment.
Read more
Based on the above the investigators hypothesize the following:
- Provoking ECH patients in bout with CGRP triggers cluster headache attacks
- Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks
- Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks more often than in ECH patients.
- Conditions
- Cluster Headache
- Being tested
- Calcitonin-Gene Related Peptide, Placebo
- Medical subject headings
- Cluster Headache
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
1,5 µg/min of IV CGRP over 20 mins
PlaceboDrug
Also called Normal saline
40 ml of normal saline over 20 mins
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 1.5µg/min IV calcitonin-gene related peptide for 20 minutes Receives: Drug: Calcitonin-Gene Related Peptide |
| Placebo | Placebo comparator | IV placebo for 20 minutes Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in occurence of cluster headache attacks on CGRP day compared to placebo day in all three groups
Occurence of experimentally induced cluster headache attack yes/no
Measured: 90 min after administration of study drug
AUC headache on CGRP day compared to placebo day in all three groups
Using 90 min headache questionnaire
Measured: 90 min after administration of study drug
Time to maximum headache score on CGRP day compared to placebo day in all three
Using 90 min headache questionnaire
Measured: 90 min after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2017
- Study completionDec 2018
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 Cluster HeadacheStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 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
- Messoud Ashina, MD, PhD,DMSc, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466334
- Sponsor's protocol ID
- H-15006836
- Status last verified
- Jul 2022
- First submitted
- 21 May 2015
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Vollesen ALH, Snoer A, Beske RP, Guo S, Hoffmann J, Jensen RH, Ashina M. Effect of Infusion of Calcitonin Gene-Related Peptide on Cluster Headache Attacks: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1187-1197. doi: 10.1001/jamaneurol.2018.1675.
PubMed 29987329
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's Cluster Headache Inducing Abilities in Cluster Headache Patients
- ClinicalTrials.gov ID
- NCT02466334
- Acronym / sponsor ID
- H-15006836
- Conditions
- Cluster Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Jun 2015 (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.
It has previously been shown that nitroglycerine induces cluster headache attacks in episodic cluster headache patients (ECH patients) in bouts but not in remission phase. Furthermore, plasma concentrations of calcitonin gene-related peptide (CGRP) have been shown to be significantly higher during, but not before and after, an attack.
The attack appears around 20-40 min after nitroglycerine infusion with vasodilatation. During this latency period preceding the attack, no increase in CGRP plasma concentrations is seen. CGRP induces migraine attacks in 65% of migraine patients, and CGRP antagonists as well as monoclonal antibodies against CGRP are effective in migraine treatment.
Based on the above the investigators hypothesize the following:
- Provoking ECH patients in bout with CGRP triggers cluster headache attacks
- Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks
- Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks more often than in ECH patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: Calcitonin-Gene Related Peptide1.5µg/min IV calcitonin-gene related peptide for 20 minutes |
| Placebo | Placebo comparator | Drug: PlaceboIV placebo for 20 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fulfillment of IHS criteria for cluster headache either chronic or episodic
- Patients in bouts 1-32 attacks per week
- Patients in remission minimum of 1 month remission time
- fertile women must use safe contraception
Key exclusion criteria (4 listed)
- All other primary types of headache
- headache 8 hours or less before study day begins
- pregnant or lactating women
- any history or clinical sigs of hyper/hypotension, heart disease, mental disorder, substance abuse, or other illness deemed relevant by the medical doctor assessing the patient
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: CGRP1,5 µg/min of IV CGRP over 20 mins | Drug | Active |
| PlaceboAlso: Normal saline40 ml of normal saline over 20 mins | Drug | Placebo |
Primary outcome
Differences in occurence of cluster headache attacks on CGRP day compared to placebo day in all three groups
Time frame: 90 min after administration of study drug
Occurence of experimentally induced cluster headache attack yes/no
AUC headache on CGRP day compared to placebo day in all three groups
Time frame: 90 min after administration of study drug
Using 90 min headache questionnaire
Time to maximum headache score on CGRP day compared to placebo day in all three
Time frame: 90 min after administration of study drug
Using 90 min headache questionnaire
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.
- Derived from this study: PubMed 29987329Vollesen ALH, Snoer A, Beske RP, Guo S, Hoffmann J, Jensen RH, Ashina M. Effect of Infusion of Calcitonin Gene-Related Peptide on Cluster Headache Attacks: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1187-1197. doi: 10.1001/jamaneurol.2018.1675.
- Individual participant dataSharing planned: Undecided
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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, MD, PhD,DMSc principal investigator
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 Cluster Headache, 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 4 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.
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?
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?
Differences in occurence of cluster headache attacks on CGRP day compared to placebo day in all three groups (time frame: 90 min after administration of study drug). The study lists 3 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 NCT02466334, 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 2 Aug 2022.