Headache, MigraineNCT04905654
Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura
A study testing Levcromakalim and Saline in people with Headache, Migraine and Aura, run by Danish Headache Center at 1 site in Denmark.
Trial summary
To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Headache, Migraine, Aura
- What is being tested?
- Levcromakalim and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Sep 2021to 16 May 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Migraine with aura patients of both sexes.
- 18-70 years.
- 50-100 kg.
Who cannot join
- Headache less than 48 hours before the tests start
- Daily consumption of drugs of any kind that investigator deems might affect study results or safety.
- Pregnant or nursing women.
- Cardiovascular disease of any kind, including cerebrovascular diseases.
- Tension type headache (TTH) according to International Classification of Headache Disorders version 3 more than 5 times a month on average during the past year
- Known cluster headache according to International Classification of Headache Disorders version 3.
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- Psychiatric disorder
- Smoking or abuse of drugs or alcohol
- Hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) on day of inclusion.
- Hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg) on day of inclusion.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center
Glostrup Municipality, Copenhagen, DK-2600
About this study
To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.
- Conditions
- Headache, Migraine, Aura
- Being tested
- Levcromakalim, Saline
- Keywords
- Levcromakalim
- Medical subject headings
- Migraine Disorders, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevcromakalimDrug
To investigate the role of levcromakalim compared with placebo in migraine with aura patients
SalineDrug
To investigate the role of levcromakalim compared with placebo in migraine with aura patients
| Study group | Role | What they receive |
|---|---|---|
| Levcromakalim | Active comparator | Not described Receives: Drug: Levcromakalim |
| Saline | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache incidence
Difference in incidence of headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
Measured: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Migraine incidence
Difference in incidence of migraine-like headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
Measured: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Aura incidence
Difference in incidence of migraine aura following infusion of levcromakalim compared to placebo in patients with migraine with aura.
Measured: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Secondary outcomes (3)
Headache intensity
The area under the curve (AUC) for headache following infusion of levcromakalim compared to placebo in patients with migraine with aura
Measured: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Heart rate
Change in heart rate measured in Beats per minute (BPM) following infusion of levcromakalim compared to placebo in patients with migraine with aura
Measured: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo
Blood pressure
Change in blood pressure (systolic and diastolic) measured in mmHg following infusion of levcromakalim compared to placebo in patients with migraine with aura
Measured: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start29 Sep 2021
- Primary completion16 May 2023
- Study completion16 May 2023
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 Headache, 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Vinther Thomsen, Danish Headache Center
- Investigators
- Messoud Ashina, Study director, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905654
- Sponsor's protocol ID
- H-20049785
- Status last verified
- May 2023
- First submitted
- 21 May 2021
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thomsen AV, Al-Karagholi MA, Hougaard A, Ostrowski SR, Ashina M. Effects of levcromakalim in patients with migraine aura without headache: An experimental study. Cephalalgia. 2024 Aug;44(8):3331024241274366. doi: 10.1177/03331024241274366.
PubMed 39161224Thomsen AV, Al-Karagholi MA, Hougaard A, Ostrowski SR, Pedersen OB, Hansen TF, Ashina M. Investigations of the migraine-provoking effect of levcromakalim in patients with migraine with aura. Cephalalgia. 2024 Mar;44(3):3331024241237247. doi: 10.1177/03331024241237247.
PubMed 38501895
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura
- ClinicalTrials.gov ID
- NCT04905654
- Acronym / sponsor ID
- H-20049785
- Conditions
- Headache, Migraine, Aura
- Keywords
- Levcromakalim
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 27 May 2021 (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.
To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levcromakalim | Active comparator | Drug: Levcromakalim |
| Saline | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Migraine with aura patients of both sexes.
- 18-70 years.
- 50-100 kg.
Key exclusion criteria (10 listed)
- Headache less than 48 hours before the tests start
- Daily consumption of drugs of any kind that investigator deems might affect study results or safety.
- Pregnant or nursing women.
- Cardiovascular disease of any kind, including cerebrovascular diseases.
- Tension type headache (TTH) according to International Classification of Headache Disorders version 3 more than 5 times a month on average during the past 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 |
|---|---|---|
| LevcromakalimTo investigate the role of levcromakalim compared with placebo in migraine with aura patients | Drug | Levcromakalim |
| SalineTo investigate the role of levcromakalim compared with placebo in migraine with aura patients | Drug | Saline |
Primary outcome
Headache incidence
Time frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Difference in incidence of headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
Migraine incidence
Time frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Difference in incidence of migraine-like headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
Aura incidence
Time frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Difference in incidence of migraine aura following infusion of levcromakalim compared to placebo in patients with migraine with aura.
3 secondary outcomes
Headache intensity
Time frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Heart rate
Time frame: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo
Blood pressure
Time frame: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo
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 17 May 2023.
- Derived from this study: PubMed 39161224Thomsen AV, Al-Karagholi MA, Hougaard A, Ostrowski SR, Ashina M. Effects of levcromakalim in patients with migraine aura without headache: An experimental study. Cephalalgia. 2024 Aug;44(8):3331024241274366. doi: 10.1177/03331024241274366.
- Derived from this study: PubMed 38501895Thomsen AV, Al-Karagholi MA, Hougaard A, Ostrowski SR, Pedersen OB, Hansen TF, Ashina M. Investigations of the migraine-provoking effect of levcromakalim in patients with migraine with aura. Cephalalgia. 2024 Mar;44(3):3331024241237247. doi: 10.1177/03331024241237247.
- 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 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 Levcromakalim and Saline in people with Headache, Migraine and 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 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: finished, as of the sponsor's last update on 17 May 2023. 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?
Headache incidence (time frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo). 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 NCT04905654, 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 17 May 2023.