Headache, MigraineNCT03228355
Headache Inducing Effect of Cromakalim in Migraine Patients
A study testing Levcromakalim and Saline in people with Headache, Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Levcromakalim and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 24 May 2017to 30 Nov 2017
- 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 patients of both sexes.
- 18-60 years.
- 50-90 kg.
- Women of childbearing potential must use adequate contraception.
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
Official title: The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.
- Conditions
- Headache, Migraine
- Being tested
- Levcromakalim, Saline
- Keywords
- Levcromakalim
- Medical subject headings
- Migraine Disorders
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 on cerebral hemodynamic in migraine patients
SalineDrug
To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine 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.
Cerebral hemodynamic
Change on Media cerebri arterie.
Measured: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
Headache
Occurrence of headache.
Measured: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Migraine attack
Occurrence
Measured: Before (-10 min) and after infusion (+12 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 posted24 Jul 2017
- Study start24 May 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
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 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
- 16 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, Professor, Study director, DHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228355
- Sponsor's protocol ID
- Levcromakalim
- Status last verified
- Jun 2018
- First submitted
- 8 Jul 2017
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Karagholi MA, Hansen JM, Guo S, Olesen J, Ashina M. Opening of ATP-sensitive potassium channels causes migraine attacks: a new target for the treatment of migraine. Brain. 2019 Sep 1;142(9):2644-2654. doi: 10.1093/brain/awz199.
PubMed 31292608
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients
- ClinicalTrials.gov ID
- NCT03228355
- Acronym / sponsor ID
- Levcromakalim
- Conditions
- Headache, Migraine
- Keywords
- Levcromakalim
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 24 Jul 2017 (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 on the cerebral hemodynamic in migraine 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 (4 listed)
- Migraine patients of both sexes.
- 18-60 years.
- 50-90 kg.
- Women of childbearing potential must use adequate contraception.
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 on cerebral hemodynamic in migraine patients | Drug | Levcromakalim |
| SalineTo investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients. | Drug | Saline |
Primary outcome
Cerebral hemodynamic
Time frame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
Change on Media cerebri arterie.
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 attack
Time frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Occurrence
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 19 Jun 2018.
- Derived from this study: PubMed 31292608Al-Karagholi MA, Hansen JM, Guo S, Olesen J, Ashina M. Opening of ATP-sensitive potassium channels causes migraine attacks: a new target for the treatment of migraine. Brain. 2019 Sep 1;142(9):2644-2654. doi: 10.1093/brain/awz199.
- Individual participant dataSharing planned: Undecided
Related trials for Headache, Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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, Professor study director
DHC
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, 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 19 Jun 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. 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?
Cerebral hemodynamic (time frame: Before (-10 min) and after infusion (+2 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 NCT03228355, 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 19 Jun 2018.