Headache, MigraineNCT04744129
Headache Inducing Effect of NN414 in Migraine Patients
A study testing NN414 and Saline in people with Headache, Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- NN414 and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Feb 2022to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Migraine patients of both sexes.
- 18-60 years.
- 50-100 kg.
- Women of childbearing potential must use adequate contraception.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Headache Center
Copenhagen, Capital Region, 2600
Lili Kokoti, MD, PhD (c), 004550207018, lili.kokoti@regionh.dk
Messoud Ashina, MD, PhD, DMSc
About this study
Official title: NN414's Effect in Cerebral Hemodynamics and Headache Induction in Migraine Patients
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.
- Conditions
- Headache, Migraine
- Being tested
- NN414, Saline
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NN414Drug
Also called 6-Chloro-3-[[1-methylcyclopropyl]amino]-4H-thieno[3,2-e]-1,2,4-thiadiazine 1,1-dioxide
To investigate the role of NN414 on cerebral hemodynamic in migraine patients
SalineDrug
To investigate the role of NN414 compared with saline cerebral hemodynamic in migraine patients.
| Study group | Role | What they receive |
|---|---|---|
| NN414 | Active comparator | To investigate the role of NN414 compared with placebo in migraine patients. Receives: Drug: NN414 |
| Saline | Placebo comparator | To investigate the role of NN414 compared with placebo in migraine patients. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and change of migraine attack
Occurrence of migraine according to international criteria
Measured: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Secondary outcomes (3)
Change in cerebral hemodynamic
Change on velocity of media cerebri artery.
Measured: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Occurrence and change of headache
Occurrence of headache measured by numerical rating scale (NRS)
Measured: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Change of diameter of the artery
Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm).
Measured: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start25 Feb 2022
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Kokoti, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744129
- Sponsor's protocol ID
- H-20009266
- Status last verified
- Feb 2023
- First submitted
- 21 Jul 2020
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38729773
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NN414's Effect in Cerebral Hemodynamics and Headache Induction in Migraine Patients
- ClinicalTrials.gov ID
- NCT04744129
- Acronym / sponsor ID
- H-20009266
- Conditions
- Headache, Migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NN414 | Active comparator | Drug: NN414To investigate the role of NN414 compared with placebo in migraine patients. |
| Saline | Placebo comparator | Drug: SalineTo investigate the role of NN414 compared with placebo in migraine patients. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Migraine patients of both sexes.
- 18-60 years.
- 50-100 kg.
- Women of childbearing potential must use adequate contraception.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NN414Also: 6-Chloro-3-[[1-methylcyclopropyl]amino]-4H-thieno[3,2-e]-1,2,4-thiadiazine 1,1-dioxideTo investigate the role of NN414 on cerebral hemodynamic in migraine patients | Drug | NN414 |
| SalineTo investigate the role of NN414 compared with saline cerebral hemodynamic in migraine patients. | Drug | Saline |
Primary outcome
Occurrence and change of migraine attack
Time frame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Occurrence of migraine according to international criteria
3 secondary outcomes
Change in cerebral hemodynamic
Time frame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Occurrence and change of headache
Time frame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Change of diameter of the artery
Time frame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Derived from this study: PubMed 38729773Kokoti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NN414 and Saline in people with Headache, Migraine, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence and change of migraine attack (time frame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04744129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.