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Headache Inducing Effect of Cromakalim in Migraine Patients

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ClinicalTrials.gov Identifier: NCT03228355
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center

Brief Summary:
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Levcromakalim Drug: Levcromakalim
To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients
Placebo Comparator: Saline Drug: Saline
To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.



Primary Outcome Measures :
  1. 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.

  2. Headache [ Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline ]
    Occurrence of headache.

  3. Migraine attack [ Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline ]
    Occurrence



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Migraine patients of both sexes.
  • 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
  • Daily consumption of drugs of any kind other than oral contraceptives
  • Pregnant or nursing women.
  • Cardiovascular disease of any kind, including cerebrovascular diseases.

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): NCT03228355


Contacts
Contact: Mohammad A Al-Karagholi, MD 00 45 31 19 16 47 mahdi.alkaragholi@gmail.com

Locations
Denmark
Danish headache center Recruiting
Copenhagen, Glostrup, Denmark, 2600
Contact: Mohammad A Al-Karagholi, MD    00 45 31 19 16 47    mahdi.alkaragholi@gmail.com   
Sponsors and Collaborators
Danish Headache Center
Investigators
Study Director: Messoud Ashina, Professor DHC

Responsible Party: Mohammad Al-Mahdi Al-Karagholi, MD, PhD student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03228355     History of Changes
Other Study ID Numbers: Levcromakalim
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center:
Levcromakalim

Additional relevant 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
Cromakalim
Antihypertensive Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Vasodilator Agents