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The Effects of Maxipost (BMS 204352) on Cerebral Hemodynamic and Headache in Healthy Volunteers and Migraine Patients

Primary Purpose

Headache, Migraine

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Maxipost

Saline

About this trial

This is an interventional other trial for Headache, Migraine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Migraine patients without aura who fulfill criteria in the international classification of headaches. This does not apply to healthy volunteers.
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
All primary headaches, except migraine without aura for migraine patients, according to international classification of headache
Daily consumption of drugs of any kind other than oral contraceptives
Pregnant or nursing women.
Cardiovascular disease of any kind, including cerebrovascular diseases.

Sites / Locations

Danish headache center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Maxipost

Saline

Arm Description

Outcomes

Primary Outcome Measures

Occurrence and change of migraine attack

Occurrence and of migraine according to international criteria

Secondary Outcome Measures

Change in cerebral hemodynamic

Change on velocity of media cerebri artery.

Occurrence and change of headache

Occurrence of headache measured by numerical rating scale (NRS)

Change of diameter of the artery

Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm).

Full Information

NCT ID

NCT03887325

First Posted

March 18, 2019

Last Updated

June 11, 2020

Sponsor

Danish Headache Center

1. Study Identification

Unique Protocol Identification Number

NCT03887325

Brief Title

The Effects of Maxipost (BMS 204352) on Cerebral Hemodynamic and Headache in Healthy Volunteers and Migraine Patients

Official Title

To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Maxipost in Healthy Volunteers and Migraine Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

February 29, 2020 (Actual)

Study Completion Date

February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

It is not previously investigated whether, there is a correlation between potassium channels and migraine, so it is unclear whether, this signaling pathway through potassium channels has an impact on migraine pathophysiology. Maxipost (BMS 204352) is a vasoactive molecule that causes vasodilation via the big calcium dependent potassium (BKCa) channel signaling pathway. Maxipost decreases the blood pressure and maxipost infusion causes headache in healthy volunteers. A possible coherence between maxipost and headache/migraine in healthy volunteers and migraine patients is yet to be investigated. The present study aims to clarify a possible coherence between maxipost and headache/migraine and it will help to shed light on the importance of potassium channels in migraine. In general, the study will contribute to a greater understanding of migraine pathogenesis and possibly lead to development of specific migraine treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Headache, Migraine

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Maxipost

Arm Type

Active Comparator

Arm Title

Saline

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Maxipost

Intervention Description

To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients

Primary Outcome Measure Information:

Title

Occurrence and change of migraine attack

Description

Occurrence and of migraine according to international criteria

Time Frame

Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline

Secondary Outcome Measure Information:

Title

Change in cerebral hemodynamic

Description

Change on velocity of media cerebri artery.

Time Frame

Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline

Title

Occurrence and change of headache

Description

Occurrence of headache measured by numerical rating scale (NRS)

Time Frame

Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline

Title

Change of diameter of the artery

Description

Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm).

Time Frame

Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Migraine patients without aura who fulfill criteria in the international classification of headaches. This does not apply to healthy volunteers. 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 All primary headaches, except migraine without aura for migraine patients, according to international classification of headache Daily consumption of drugs of any kind other than oral contraceptives Pregnant or nursing women. Cardiovascular disease of any kind, including cerebrovascular diseases.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Messoud A Ashina

Organizational Affiliation

Danish Headache Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Danish headache center

City

Glostrup

State/Province

Copenhagen

ZIP/Postal Code

2600

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34252916

Citation

Al-Karagholi MA, Ghanizada H, Waldorff Nielsen CA, Skandarioon C, Snellman J, Lopez-Lopez C, Hansen JM, Ashina M. Opening of BKCa channels causes migraine attacks: a new downstream target for the treatment of migraine. Pain. 2021 Oct 1;162(10):2512-2520. doi: 10.1097/j.pain.0000000000002238.

Results Reference

derived

PubMed Identifier

32847403

Citation

Al-Karagholi MA, Ghanizada H, Nielsen CAW, Skandarioon C, Snellman J, Lopez Lopez C, Hansen JM, Ashina M. Opening of BKCa channels alters cerebral hemodynamic and causes headache in healthy volunteers. Cephalalgia. 2020 Oct;40(11):1145-1154. doi: 10.1177/0333102420940681. Epub 2020 Aug 26.

Results Reference

derived

Learn more about this trial

The Effects of Maxipost (BMS 204352) on Cerebral Hemodynamic and Headache in Healthy Volunteers and Migraine Patients

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