Headache Inducing Effect of NN414 in Migraine Patients

NCT ID: NCT04744129

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-25

Study Completion Date

2023-02-28

Brief Summary

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

Detailed Description

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Conditions

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Headache, Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Quadruple

Study Groups

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NN414

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

Group Type ACTIVE_COMPARATOR

NN414

Intervention Type DRUG

To investigate the role of NN414 on cerebral hemodynamic in migraine patients

Saline

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

To investigate the role of NN414 compared with saline cerebral hemodynamic in migraine patients.

Interventions

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NN414

To investigate the role of NN414 on cerebral hemodynamic in migraine patients

Intervention Type DRUG

Saline

To investigate the role of NN414 compared with saline cerebral hemodynamic in migraine patients.

Intervention Type DRUG

Other Intervention Names

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6-Chloro-3-[[1-methylcyclopropyl]amino]-4H-thieno[3,2-e]-1,2,4-thiadiazine 1,1-dioxide

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Lili Kokoti

MD, PhD student, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Danish Headache Center

Copenhagen, Capital Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Lili Kokoti, MD, PhD (c)

Role: primary

004550207018

References

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Kokoti L, Al-Karagholi MA, Zhuang ZA, Amirguliyev S, Amin FM, Ashina M. Non-vascular ATP-sensitive potassium channel activation does not trigger migraine attacks: A randomized clinical trial. Cephalalgia. 2024 May;44(5):3331024241248211. doi: 10.1177/03331024241248211.

Reference Type DERIVED
PMID: 38729773 (View on PubMed)

Other Identifiers

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H-20009266

Identifier Type: -

Identifier Source: org_study_id

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