Headache Inducing Effect of NN414 in Migraine Patients

Danish Headache Center

Status: Enrolling

Conditions: Headache, Migraine

Treatments: Drug: Saline; Drug: NN414

Study type: Interventional

Funder types: Other

Identifiers

NCT04744129

H-20009266

Details and patient eligibility

About

To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

NN414

Active Comparator group

Description:

To investigate the role of NN414 compared with placebo in migraine patients.

Treatment:

Drug: NN414

Saline

Placebo Comparator group

Description:

To investigate the role of NN414 compared with placebo in migraine patients.

Treatment:

Drug: Saline