An interventional study of Telephone by nurse in Migraine, Chronic Tension-Type Headache and Cluster Headache, sponsored by Norwegian University of Science and Technology. Terminated at 1 site in Norway. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment
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.
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 147 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Norwegian University of Science and Technology is the lead sponsor of 495 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
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.
Other: Telephone by nurse
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
Patient-initiated follow-up at week 2 and 6
Compliance
number of participants who have carried out the prescribed preventive treatment, as in minimum duration of two months after the initial visit
Time frame: 2 months
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
Time frame: 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
Time frame: 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Publication by home page of NorHead
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: In the near future
Access criteria: https://www.ntnu.no/norhead/om
Data sharing details ↗ · www.ntnu.no
Ran from Apr 2023 to primary completion in Jan 2026, 33 months.
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This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Norwegian University of Science and Technology →