HeadacheNCT04012047
Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
A study testing Levcromakalim and Saline in people with Headache and Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
To investigate the role of KATP channels in migraine with aura patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Levcromakalim and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Jul 2019to 10 Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Migraine with aura patients of both sexes.
- 18-60 years.
- 50-100 kg.
Who cannot join
- Headache less than 48 hours before the tests start
- Daily consumption of drugs of any kind other than oral contraceptives
- Pregnant or nursing women.
- Cardiovascular disease of any kind, including cerebrovascular diseases.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the role of KATP channels in migraine with aura patients.
- Being tested
- Levcromakalim, Saline
- Keywords
- Levcromakalim
- Medical subject headings
- Headache, 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
Occurrence of headache
Measured: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Migraine
Occurrence of migraine
Measured: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Aura
Occurrence of aura
Measured: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Secondary outcomes (4)
The area under the curve (AUC) for headache
Headache intensity
Measured: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Family history
Direct interview with the 1 st degree family memeber for included patients according to international classification of headaches.
Measured: After including the patients in the study.
Heart rate
Change in heart rate measured in Beats per minute (BPM)
Measured: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
Blood pressure
Change in blood pressure measured in mmHg
Measured: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start9 Jul 2019
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
- Investigators
- Messoud Ashina, Study director, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012047
- Sponsor's protocol ID
- Journal-nr.: H-19023571
- Status last verified
- Feb 2020
- First submitted
- 4 Jul 2019
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Karagholi MA, Ghanizada H, Nielsen CAW, Hougaard A, Ashina M. Opening of ATP sensitive potassium channels causes migraine attacks with aura. Brain. 2021 Sep 4;144(8):2322-2332. doi: 10.1093/brain/awab136.
PubMed 33768245
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
- ClinicalTrials.gov ID
- NCT04012047
- Acronym / sponsor ID
- Journal-nr.: H-19023571
- Keywords
- Levcromakalim
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 9 Jul 2019 (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 role of KATP channels in migraine with aura patients.
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 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Migraine with aura patients of both sexes.
- 18-60 years.
- 50-100 kg.
Key exclusion criteria (4 listed)
- Headache less than 48 hours before the tests start
- Daily consumption of drugs of any kind other than oral contraceptives
- Pregnant or nursing women.
- Cardiovascular disease of any kind, including cerebrovascular diseases.
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
Time frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Occurrence of headache
Migraine
Time frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Occurrence of migraine
Aura
Time frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Occurrence of aura
4 secondary outcomes
The area under the curve (AUC) for headache
Time frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Family history
Time frame: After including the patients in the study.
Heart rate
Time frame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
Blood pressure
Time frame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
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 Mar 2020.
- Derived from this study: PubMed 33768245Al-Karagholi MA, Ghanizada H, Nielsen CAW, Hougaard A, Ashina M. Opening of ATP sensitive potassium channels causes migraine attacks with aura. Brain. 2021 Sep 4;144(8):2322-2332. doi: 10.1093/brain/awab136.
- 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 and 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 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 Mar 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?
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 (time frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline). 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 NCT04012047, 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 Mar 2020.