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Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients

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ClinicalTrials.gov Identifier: NCT04012047
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center

Brief Summary:
To investigate the role of KATP channels in migraine with aura patients.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
Estimated Study Start Date : July 10, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Active Comparator: Levcromakalim Drug: Levcromakalim
To investigate the role of levcromakalim compared with placebo in migraine with aura patients

Placebo Comparator: Saline Drug: Saline
To investigate the role of levcromakalim compared with placebo in migraine with aura patients




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

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

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



Information from the National Library of Medicine

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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 with aura patients of both sexes.
  • 18-50 years.
  • 50-90 kg.

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): NCT04012047


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

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

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Responsible Party: Mohammad Al-Mahdi Al-Karagholi, MD, PhD student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT04012047     History of Changes
Other Study ID Numbers: Journal-nr.: H-19023571
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Migraine Disorders
Headache
Migraine with Aura
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