Headache, MigraineNCT03887325
The Effects of Maxipost (BMS 204352) on Cerebral Hemodynamic and Headache in Healthy Volunteers and Migraine Patients
A study testing Maxipost and Saline in people with Headache, Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
It is not previously investigated whether, there is a correlation between potassium channels and migraine, so it is unclear whether, this signaling pathway through potassium channels has an impact on migraine pathophysiology. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Maxipost and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2019to 29 Feb 2020
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Migraine patients without aura who fulfill criteria in the international classification of headaches. This does not apply to healthy volunteers.
- 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
- All primary headaches, except migraine without aura for migraine patients, according to international classification of headache
- 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: To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Maxipost in Healthy Volunteers and Migraine Patients
It is not previously investigated whether, there is a correlation between potassium channels and migraine, so it is unclear whether, this signaling pathway through potassium channels has an impact on migraine pathophysiology.
Maxipost (BMS 204352) is a vasoactive molecule that causes vasodilation via the big calcium dependent potassium (BKCa) channel signaling pathway. Maxipost decreases the blood pressure and maxipost infusion causes headache in healthy volunteers. A possible coherence between maxipost and headache/migraine in healthy volunteers and migraine patients is yet to be investigated.
The present study aims to clarify a possible coherence between maxipost and headache/migraine and it will help to shed light on the importance of potassium channels in migraine. In general, the study will contribute to a greater understanding of migraine pathogenesis and possibly lead to development of specific migraine treatment.
- Conditions
- Headache, Migraine
- Being tested
- Maxipost, Saline
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaxipostDrug
To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients
SalineDrug
To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients
| Study group | Role | What they receive |
|---|---|---|
| Maxipost | Active comparator | Not described Receives: Drug: Maxipost |
| 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.
Occurrence and change of migraine attack
Occurrence and of migraine according to international criteria
Measured: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline
Secondary outcomes (3)
Change in cerebral hemodynamic
Change on velocity of media cerebri artery.
Measured: Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline
Occurrence and change of headache
Occurrence of headache measured by numerical rating scale (NRS)
Measured: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline
Change of diameter of the artery
Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm).
Measured: Before (-10 minutes) and after infusion (+2 hours) of maxipost 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 posted22 Mar 2019
- Study start1 Apr 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
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
- 43 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 A Ashina, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887325
- Sponsor's protocol ID
- Maxipost P H-18052101
- Status last verified
- Jun 2020
- First submitted
- 18 Mar 2019
- Last updated
- 16 Jun 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, Waldorff Nielsen CA, Skandarioon C, Snellman J, Lopez-Lopez C, Hansen JM, Ashina M. Opening of BKCa channels causes migraine attacks: a new downstream target for the treatment of migraine. Pain. 2021 Oct 1;162(10):2512-2520. doi: 10.1097/j.pain.0000000000002238.
PubMed 34252916Al-Karagholi MA, Ghanizada H, Nielsen CAW, Skandarioon C, Snellman J, Lopez Lopez C, Hansen JM, Ashina M. Opening of BKCa channels alters cerebral hemodynamic and causes headache in healthy volunteers. Cephalalgia. 2020 Oct;40(11):1145-1154. doi: 10.1177/0333102420940681. Epub 2020 Aug 26.
PubMed 32847403
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Maxipost in Healthy Volunteers and Migraine Patients
- ClinicalTrials.gov ID
- NCT03887325
- Acronym / sponsor ID
- Maxipost P H-18052101
- Conditions
- Headache, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 22 Mar 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.
It is not previously investigated whether, there is a correlation between potassium channels and migraine, so it is unclear whether, this signaling pathway through potassium channels has an impact on migraine pathophysiology.
Maxipost (BMS 204352) is a vasoactive molecule that causes vasodilation via the big calcium dependent potassium (BKCa) channel signaling pathway. Maxipost decreases the blood pressure and maxipost infusion causes headache in healthy volunteers. A possible coherence between maxipost and headache/migraine in healthy volunteers and migraine patients is yet to be investigated.
The present study aims to clarify a possible coherence between maxipost and headache/migraine and it will help to shed light on the importance of potassium channels in migraine. In general, the study will contribute to a greater understanding of migraine pathogenesis and possibly lead to development of specific migraine treatment.
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 |
|---|---|---|
| Maxipost | Active comparator | Drug: Maxipost |
| Saline | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Migraine patients without aura who fulfill criteria in the international classification of headaches. This does not apply to healthy volunteers.
- 18-60 years.
- 50-90 kg.
- Women of childbearing potential must use adequate contraception.
Key exclusion criteria (5 listed)
- Headache less than 48 hours before the tests start
- All primary headaches, except migraine without aura for migraine patients, according to international classification of headache
- 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 |
|---|---|---|
| MaxipostTo investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients | Drug | Maxipost |
| SalineTo investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients | Drug | Saline |
Primary outcome
Occurrence and change of migraine attack
Time frame: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline
Occurrence and of migraine according to international criteria
3 secondary outcomes
Change in cerebral hemodynamic
Time frame: Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline
Occurrence and change of headache
Time frame: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline
Change of diameter of the artery
Time frame: Before (-10 minutes) and after infusion (+2 hours) of maxipost 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 16 Jun 2020.
- Derived from this study: PubMed 34252916Al-Karagholi MA, Ghanizada H, Waldorff Nielsen CA, Skandarioon C, Snellman J, Lopez-Lopez C, Hansen JM, Ashina M. Opening of BKCa channels causes migraine attacks: a new downstream target for the treatment of migraine. Pain. 2021 Oct 1;162(10):2512-2520. doi: 10.1097/j.pain.0000000000002238.
- Derived from this study: PubMed 32847403Al-Karagholi MA, Ghanizada H, Nielsen CAW, Skandarioon C, Snellman J, Lopez Lopez C, Hansen JM, Ashina M. Opening of BKCa channels alters cerebral hemodynamic and causes headache in healthy volunteers. Cephalalgia. 2020 Oct;40(11):1145-1154. doi: 10.1177/0333102420940681. Epub 2020 Aug 26.
- 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 A Ashina 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 Maxipost 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 5 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 16 Jun 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?
Occurrence and change of migraine attack (time frame: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline). 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 NCT03887325, 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 16 Jun 2020.