Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

• Sponsor: Danish Headache Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04905654
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.

Condition or Disease	Intervention/Treatment	Phase
Headache, Migraine; Aura	Drug: Levcromakalim; Drug: Saline	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura
• Actual Study Start Date: Sep 29, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

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 incidence [10 minutes before until 24 hours after infusion of levcromakalim or placebo]

   Difference in incidence of headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.

2. Migraine incidence [10 minutes before until 24 hours after infusion of levcromakalim or placebo]

   Difference in incidence of migraine-like headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.

3. Aura incidence [10 minutes before until 24 hours after infusion of levcromakalim or placebo]

   Difference in incidence of migraine aura following infusion of levcromakalim compared to placebo in patients with migraine with aura.

Secondary Outcome Measures

1. Headache intensity [10 minutes before until 24 hours after infusion of levcromakalim or placebo]

   The area under the curve (AUC) for headache following infusion of levcromakalim compared to placebo in patients with migraine with aura

2. Heart rate [10 minutes before until 120 minutes after infusion of levcromakalim or placebo]

   Change in heart rate measured in Beats per minute (BPM) following infusion of levcromakalim compared to placebo in patients with migraine with aura

3. Blood pressure [10 minutes before until 120 minutes after infusion of levcromakalim or placebo]

   Change in blood pressure (systolic and diastolic) measured in mmHg following infusion of levcromakalim compared to placebo in patients with migraine with aura

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 that investigator deems might affect study results or safety.

• Pregnant or nursing women.

• Cardiovascular disease of any kind, including cerebrovascular diseases.

• Tension type headache (TTH) according to International Classification of Headache Disorders version 3 more than 5 times a month on average during the past year

• Known cluster headache according to International Classification of Headache Disorders version 3.

• Psychiatric disorder

• Smoking or abuse of drugs or alcohol

• Hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) on day of inclusion.

• Hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg) on day of inclusion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Danish Headache Center	Glostrup	Copenhagen	Denmark	DK-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: Andreas Vinther Thomsen, Principal Investigator, Danish Headache Center
• ClinicalTrials.gov Identifier: NCT04905654
• Other Study ID Numbers: H-20049785
• First Posted: May 27, 2021
• Last Update Posted: Oct 15, 2021
• Last Verified: Oct 1, 2021

• 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 Andreas Vinther Thomsen, Principal Investigator, Danish Headache Center: Levcromakalim
• Additional relevant MeSH terms: Migraine Disorders; Migraine with Aura; Headache; Cromakalim

Study Results

No Results Posted as of Oct 15, 2021