NCT03887325

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

March 18, 2019

Last Update Submit

June 11, 2020

Conditions

Headache, Migraine

Outcome Measures

Primary Outcomes (1)

  • Occurrence and change of migraine attack

    Occurrence and of migraine according to international criteria

    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

    Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline

  • Occurrence and change of headache

    Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline

  • Change of diameter of the artery

    Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline

Study Arms (2)

Maxipost

ACTIVE COMPARATOR
Drug: Maxipost

Saline

PLACEBO COMPARATOR
Drug: Saline

Interventions

MaxipostDRUG

To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients

Maxipost
SalineDRUG

To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients

Saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Migraine patients without aura who fulfill criteria in the international classification of headaches. This does not apply to healthy volunteers.
  • years.
  • kg.
  • Women of childbearing potential must use adequate contraception.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish headache center

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 34252916DERIVED

  • Al-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.

    PMID: 32847403DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

BMS204352Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Messoud A Ashina

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student, Principal investigator

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 22, 2019

Study Start

April 1, 2019

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations

DK(1)