MigraineNCT06200480
Nurse Intervention Trial
A study testing Telephone by nurse in people with Migraine and Chronic Tension-Type Headache, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This randomized open-label prospective study focus on headache patients initiating preventive treatment, where the treating physician identifies a need for follow-up visits in specialized healthcare. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Migraine, Chronic Tension-Type Headache, Cluster Headache
- What is being tested?
- Telephone by nurse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteNorway
- Study dates
- 21 Apr 2023to 31 Jan 2026
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One of the following headache diagnoses based on the International Classification of Headache Disorders, third edition (ICDH3): G44.2 Chronic tension-type headache and/or G43 Episodic and chronic migraine, G44.0 Episodic and chronic cluster headache, G44.8 Hemicrania Continua
- Indication for preventive medication where there is at least one alternative with the need for follow-up assessment of effectiveness.
Who cannot join
- Uncertain headache diagnosis.
- Need further investigation after the initial consultation.
- Lack of understanding of information provided in Norwegian, both verbally and in writing.
- Inability to keep a digital headache diary.
- Need treatment of other comorbid conditions requiring follow-up in specialized healthcare.
- Treatment with Onabotulinumtoxin A or Calcitonin-gene-related Peptide (CGRP) inhibitors given with three months intervals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse Intervention Trial: The Evaluation of Usefulness of a Headache Nurse
This randomized open-label prospective study focus on headache patients initiating preventive treatment, where the treating physician identifies a need for follow-up visits in specialized healthcare. The study will clarify whether the implementation (compliance) and overall satisfaction of the patient are better with follow-up by a headache nurse compared to standard follow-up. Patients with signed written consent will be randomised to either group a: Telephone calls from nurse after two and 6 week or B. Patient-initiated follow-up by their general practitioner.
Read the detailed description
Potential patients suitable for this study must have undergone a regular consultation with a neurologist before. This consultation includes neurological and somatic examinations, diagnosis of the type of headache based on medical history, review of a completed headache diary, and any additional conducted examinations. The consultation will also involve an assessment of the possible initiation of preventive treatment. A selection of these patients will be prescribed electronic prescriptions for at least one previously untried type of preventive medication. During the consultation, patients will receive oral and written information about the dosage and expected possible side effects of the preventive medication. Those eligible for beta-blocker initiation will undergo an electrocardiogram (EKG) after the consultation. After completing the consultation, eligible patients will receive written and oral information about the study.
Those who provide consent to participate will, during subsequent registration with the secretaries at the neurological outpatient clinic immediately after the consultation, be randomized to one of two follow-up options (A or B) for further monitoring in the coming months until the scheduled follow-up, set at approximately 3 months, or later if there is a shortage of available appointments.
Group A will be followed up by a headache nurse through telephone consultations on at least two occasions shortly after the initiation of preventive medicine. Participants in this group will be invited to a planned final follow-up appointment after approximately 3 months with a neurologist.
Group B will have patient-managed follow-up with a planned final follow-up appointment after approximately 3 months. Participants will pick up the prescribed medication and contact their general practitioner or the neurological outpatient clinic by a study-specific email if they need advice from a neurologist.
- Being tested
- Telephone by nurse
- Medical subject headings
- Migraine Disorders, Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone by nurseOther
Patient-initiated follow-up at week 2 and 6
| Study group | Role | What they receive |
|---|---|---|
| Telephone by nurse | Active comparator | The headache patients will be contacted by nurse by phone after approximately 2 week and 6 week after start of preventive medical treatment. The patient will have a follow-up visit by neurologist after 3 months. Receives: Other: Telephone by nurse |
| Patient-initiated follow-up | No intervention | The headache patient contact their general practitioner (GP) and/or the neurologist by a study-specific email if they have questions regarding the preventive medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
number of participants who have carried out the prescribed preventive treatment, as in minimum duration of two months after the initial visit
Measured: 2 months
Secondary outcomes (2)
Number of days to at least a 30% reduction
Number of days from inclusion to at least a 30% reduction erate to severe headache compared to in the frequency in the last month before the initial consultation
Measured: 3 months
Responders
Numbers of responders defined as> 50% decrease in headache days compared to in the frequency in the last month before the initial consultation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start21 Apr 2023
- Primary completion21 Jan 2026
- Study completion31 Jan 2026
Why it stopped: Based on ethical considerations arising from the interim analyses, the study was terminated before the planned sample size of 400 participants was reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label randomized prospetive study
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Oslo University Hospital, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Geir Braathen, Study chair, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200480
- Sponsor's protocol ID
- 2023-554940
- Other IDs
- 2023
- Status last verified
- Apr 2026
- First submitted
- 14 Dec 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication by home page of NorHead
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Intervention Trial: The Evaluation of Usefulness of a Headache Nurse
- ClinicalTrials.gov ID
- NCT06200480
- Acronym / sponsor ID
- 2023-554940
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on ethical considerations arising from the interim analyses, the study was terminated before the planned sample size of 400 participants was reached
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Oslo University Hospital, St. Olavs Hospital
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 11 Jan 2024 (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.
This randomized open-label prospective study focus on headache patients initiating preventive treatment, where the treating physician identifies a need for follow-up visits in specialized healthcare. The study will clarify whether the implementation (compliance) and overall satisfaction of the patient are better with follow-up by a headache nurse compared to standard follow-up. Patients with signed written consent will be randomised to either group a: Telephone calls from nurse after two and 6 week or B. Patient-initiated follow-up by their general practitioner.
Detailed description
Potential patients suitable for this study must have undergone a regular consultation with a neurologist before. This consultation includes neurological and somatic examinations, diagnosis of the type of headache based on medical history, review of a completed headache diary, and any additional conducted examinations. The consultation will also involve an assessment of the possible initiation of preventive treatment. A selection of these patients will be prescribed electronic prescriptions for at least one previously untried type of preventive medication. During the consultation, patients will receive oral and written information about the dosage and expected possible side effects of the preventive medication. Those eligible for beta-blocker initiation will undergo an electrocardiogram (EKG) after the consultation. After completing the consultation, eligible patients will receive written and oral information about the study.
Those who provide consent to participate will, during subsequent registration with the secretaries at the neurological outpatient clinic immediately after the consultation, be randomized to one of two follow-up options (A or B) for further monitoring in the coming months until the scheduled follow-up, set at approximately 3 months, or later if there is a shortage of available appointments.
Group A will be followed up by a headache nurse through telephone consultations on at least two occasions shortly after the initiation of preventive medicine. Participants in this group will be invited to a planned final follow-up appointment after approximately 3 months with a neurologist.
Group B will have patient-managed follow-up with a planned final follow-up appointment after approximately 3 months. Participants will pick up the prescribed medication and contact their general practitioner or the neurological outpatient clinic by a study-specific email if they need advice from a neurologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label randomized prospetive study
| Arm | Type | Receives |
|---|---|---|
| Telephone by nurse | Active comparator | Other: Telephone by nurseThe headache patients will be contacted by nurse by phone after approximately 2 week and 6 week after start of preventive medical treatment. The patient will have a follow-up visit by neurologist after 3 months. |
| Patient-initiated follow-up | No intervention | –The headache patient contact their general practitioner (GP) and/or the neurologist by a study-specific email if they have questions regarding the preventive medical treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- One of the following headache diagnoses based on the International Classification of Headache Disorders, third edition (ICDH3): G44.2 Chronic tension-type headache and/or G43 Episodic and chronic migraine, G44.0 Episodic and chronic cluster headache, G44.8 Hemicrania Continua
- Indication for preventive medication where there is at least one alternative with the need for follow-up assessment of effectiveness.
Key exclusion criteria (6 listed)
- Uncertain headache diagnosis.
- Need further investigation after the initial consultation.
- Lack of understanding of information provided in Norwegian, both verbally and in writing.
- Inability to keep a digital headache diary.
- Need treatment of other comorbid conditions requiring follow-up in specialized healthcare.
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 |
|---|---|---|
| Telephone by nursePatient-initiated follow-up at week 2 and 6 | Other | Telephone by nurse |
Primary outcome
Compliance
Time frame: 2 months
number of participants who have carried out the prescribed preventive treatment, as in minimum duration of two months after the initial visit
2 secondary outcomes
Number of days to at least a 30% reduction
Time frame: 3 months
Responders
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Based on ethical considerations arising from the interim analyses, the study was terminated before the planned sample size of 400 participants was reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Information by requestLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Publication by home page of NorHead
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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.
Geir Braathen study chair
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone by nurse in people with Migraine and Chronic Tension-Type Headache, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 13 Apr 2026. 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 Norway. 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. 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?
The study was stopped early (reason given: Based on ethical considerations arising from the interim analyses, the study was terminated before the planned sample size of 400 participants was reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2026.