Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Maxipost (BMS 204352) on Cerebral Hemodynamic and Headache in Healthy Volunteers and Migraine Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887325
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Headache, Migraine Drug: Maxipost Drug: Saline Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Maxipost in Healthy Volunteers and Migraine Patients
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Maxipost Drug: Maxipost
To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients
Placebo Comparator: Saline Drug: Saline
To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in cerebral hemodynamic [ Time Frame: Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline ]
    Change on velocity of media cerebri artery. Change on velocity will be measured with centimeter (cm) /second.

  2. 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 ]
    Occurrence of headache measured by numerical rating scale (NRS)

  3. 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

  4. 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 ]
    Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by centimeter (cm)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887325


Contacts
Layout table for location contacts
Contact: Mohammad A Al-Karagholi 31191647 mahdi.alkaragholi@gmail.com

Locations
Layout table for location information
Denmark
Danish headache center Recruiting
Glostrup, Copenhagen, Denmark, 2600
Contact: Mohammad A Al-Karagholi    31191647    mahdi.alkaragholi@gmail.com   
Sponsors and Collaborators
Danish Headache Center
Investigators
Layout table for investigator information
Principal Investigator: Messoud A Ashina Danish Headache Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Mohammad Al-Mahdi Al-Karagholi, MD, PhD student, Principal investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03887325     History of Changes
Other Study ID Numbers: Maxipost P H-18052101
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms