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Headache Inducing Effect of Cromakalim in Migraine Patients

This study is currently recruiting participants.
Verified July 2017 by Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03228355
First Posted: July 24, 2017
Last Update Posted: July 24, 2017
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.
Information provided by (Responsible Party):
Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
  Purpose
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.

Condition Intervention
Headache, Migraine Drug: Levcromakalim Drug: Saline

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center:

Primary Outcome Measures:
  • Cerebral hemodynamic [ Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline ]
    Change on Media cerebri arterie.

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

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


Estimated Enrollment: 12
Anticipated Study Start Date: July 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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.


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.
  Contacts and Locations
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
  More Information

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 Submitted: July 8, 2017
First Posted: July 24, 2017
Last Update Posted: July 24, 2017
Last Verified: July 2017
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


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