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

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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

Tracking Information
First Submitted Date  ICMJE March 18, 2019
First Posted Date  ICMJE March 22, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2019)
  • 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.
  • 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)
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • 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) /sekund.
  • 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)
  • 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 criterier
  • Change of diameter of the artery [ Time Frame: efore (-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)
Change History Complete list of historical versions of study NCT03887325 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Maxipost (BMS 204352) on Cerebral Hemodynamic and Headache in Healthy Volunteers and Migraine Patients
Official Title  ICMJE To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Maxipost in Healthy Volunteers and Migraine Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Headache, Migraine
Intervention  ICMJE
  • Drug: Maxipost
    To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients
  • Drug: Saline
    To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients
Study Arms  ICMJE
  • Active Comparator: Maxipost
    Intervention: Drug: Maxipost
  • Placebo Comparator: Saline
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mohammad A Al-Karagholi 31191647 mahdi.alkaragholi@gmail.com
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03887325
Other Study ID Numbers  ICMJE Maxipost P H-18052101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
Study Sponsor  ICMJE Danish Headache Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Messoud A Ashina Danish Headache Center
PRS Account Danish Headache Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP