Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients

• Sponsor: Danish Headache Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04012047
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.1
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 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
• Actual Study Start Date: Jul 9, 2019
• Actual Primary Completion Date: Dec 10, 2019
• Actual Study Completion Date: Dec 10, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Headache [Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline]

   Occurrence of headache

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

   Occurrence of migraine

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

   Occurrence of aura

Secondary Outcome Measures

1. The area under the curve (AUC) for headache [Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline]

   Headache intensity

2. Family history [After including the patients in the study.]

   Direct interview with the 1 st degree family memeber for included patients according to international classification of headaches.

3. Heart rate [Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline]

   Change in heart rate measured in Beats per minute (BPM)

4. Blood pressure [Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline]

   Change in blood pressure measured in mmHg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Migraine with aura patients of both sexes.

• 18-60 years.

• 50-100 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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Danish Headache Center

Investigators

• Study Director: Messoud Ashina, Danish Headache Center

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: NCT04012047
• Other Study ID Numbers: Journal-nr.: H-19023571
• First Posted: Jul 9, 2019
• Last Update Posted: Mar 2, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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, MD, PhD student, Danish Headache Center: Levcromakalim
• Additional relevant MeSH terms: Migraine Disorders; Migraine with Aura; Headache; Cromakalim

Study Results

No Results Posted as of Mar 2, 2020