Headache Inducing Effect of Cromakalim in Migraine Patients

NCT ID: NCT03228355

Last Updated: 2018-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-24

Study Completion Date

2017-11-30

Brief Summary

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

Detailed Description

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Conditions

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Headache, Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Levcromakalim

Group Type ACTIVE_COMPARATOR

Levcromakalim

Intervention Type DRUG

To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.

Interventions

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Levcromakalim

To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients

Intervention Type DRUG

Saline

To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Al-Mahdi Al-Karagholi

MD, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Messoud Ashina, Professor

Role: STUDY_DIRECTOR

DHC

Locations

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Danish headache center

Copenhagen, Glostrup, Denmark

Site Status

Countries

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Denmark

References

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Al-Karagholi MA, Hansen JM, Guo S, Olesen J, Ashina M. Opening of ATP-sensitive potassium channels causes migraine attacks: a new target for the treatment of migraine. Brain. 2019 Sep 1;142(9):2644-2654. doi: 10.1093/brain/awz199.

Reference Type DERIVED
PMID: 31292608 (View on PubMed)

Other Identifiers

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Levcromakalim

Identifier Type: -

Identifier Source: org_study_id

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