Headache Inducing Effect of Cromakalim in Migraine Patients

Sponsor

Danish Headache Center (Other)

Overall Status

Completed

CT.gov ID

NCT03228355

Collaborator

(none)

Enrollment

Location

Arms

6.2

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 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 24, 2017

Actual Primary Completion Date :

Nov 30, 2017

Actual Study Completion Date :

Nov 30, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Cerebral hemodynamic [Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline]
Change on Media cerebri arterie.
Headache [Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline]
Occurrence of headache.
Migraine attack [Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline]
Occurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Danish headache center	Copenhagen	Glostrup	Denmark	2600

Sponsors and Collaborators

Danish Headache Center

Investigators

Study Director: Messoud Ashina, Professor, DHC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammad Al-Mahdi Al-Karagholi, MD, PhD student, Danish Headache Center

ClinicalTrials.gov Identifier:

NCT03228355

Other Study ID Numbers:

Levcromakalim

First Posted:

Jul 24, 2017

Last Update Posted:

Jun 19, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohammad Al-Mahdi Al-Karagholi, MD, PhD student, Danish Headache Center

Levcromakalim

Additional relevant MeSH terms:

Migraine Disorders

Headache

Cromakalim

Study Results

No Results Posted as of Jun 19, 2018