Back to resultsHeadache Inducing Effect of NN414 in Migraine Patients
Primary Purpose
Headache, Migraine
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
NN414
Saline
Sponsored by
About this trial
This is an interventional other trial for Headache, Migraine
Eligibility Criteria
Criteria
Inclusion Criteria:
- Migraine patients of both sexes.
- 18-60 years.
- 50-100 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.
- Diabetes mellitus and other endocrinologic disease
Sites / Locations
- Danish Headache CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
NN414
Saline
Arm Description
To investigate the role of NN414 compared with placebo in migraine patients.
To investigate the role of NN414 compared with placebo in migraine patients.
Outcomes
Primary Outcome Measures
Occurrence and change of migraine attack
Occurrence 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
NCT04744129
First Posted
July 21, 2020
Last Updated
February 10, 2023
Sponsor
Danish Headache Center
1. Study Identification
Unique Protocol Identification Number
NCT04744129
Brief Title
Headache Inducing Effect of NN414 in Migraine Patients
Official Title
NN414's Effect in Cerebral Hemodynamics and Headache Induction in Migraine Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.
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
Masking Description
Quadruple
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NN414
Arm Type
Active Comparator
Arm Description
To investigate the role of NN414 compared with placebo in migraine patients.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
To investigate the role of NN414 compared with placebo in migraine patients.
Intervention Type
Drug
Intervention Name(s)
NN414
Other Intervention Name(s)
6-Chloro-3-[[1-methylcyclopropyl]amino]-4H-thieno[3,2-e]-1,2,4-thiadiazine 1,1-dioxide
Intervention Description
To investigate the role of NN414 on cerebral hemodynamic in migraine patients
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
To investigate the role of NN414 compared with saline cerebral hemodynamic in migraine patients.
Primary Outcome Measure Information:
Title
Occurrence and change of migraine attack
Description
Occurrence of migraine according to international criteria
Time Frame
Before (-10 min) and after infusion (+2 hours) of NN414 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 min) and after infusion (+2 hours) of NN414 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 min) and after infusion (+2 hours) of NN414 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 min) and after infusion (+2 hours) of NN414 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
No
Eligibility Criteria
Criteria
Inclusion Criteria:
Migraine patients of both sexes.
18-60 years.
50-100 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.
Diabetes mellitus and other endocrinologic disease
Facility Information:
Facility Name
Danish Headache Center
City
Copenhagen
State/Province
Capital Region
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Kokoti, MD, PhD (c)
Phone
004550207018
Email
lili.kokoti@regionh.dk
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, MD, PhD, DMSc
12. IPD Sharing Statement
Learn more about this trial
Headache Inducing Effect of NN414 in Migraine Patients
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