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Efficacy of prophylactic medication in migraine

Efficacy of prophylactic medication in migraine : A prospective multicenter observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010555
Enrollment
850
Registered
2025-05-28
Start date
2020-01-06
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Pusan National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible participants are adult patients aged between 18 and 65 years who visit the neurology department of the hospital and meet the following criteria: A. Patients who meet the diagnostic criteria in the table below: Migraine with Aura A) At least two attacks fulfilling criteria B and C B) One or more of the following fully reversible aura symptoms: ? Visual ? Sensory ? Speech and/or language ? Motor ? Brainstem ? Retinal C) At least three of the following six characteristics: i. At least one aura symptom develops gradually over =5 minutes ii. Two or more aura symptoms occur in succession iii. Each individual aura symptom lasts between 5 and 60 minutes iv. At least one aura symptom is unilateral v. At least one aura symptom is positive vi. The aura is accompanied by or followed within 60 minutes by headache D) Not better accounted for by another ICHD-3 diagnosis Migraine without Aura A) At least five attacks fulfilling criteria B–D B) Headache attacks lasting 4 to 72 hours (when untreated or unsuccessfully treated) C) Headache has at least two of the following four characteristics: i. Unilateral location ii. Pulsating quality iii. Moderate or severe pain intensity iv. Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) D) During headache, at least one of the following: i. Nausea and/or vomiting ii. Photophobia and phonophobia E) Not better accounted for by another ICHD-3 diagnosis B. No evidence of other central nervous system abnormalities, and no abnormal findings suggestive of central lesions on brain imaging, neurological examination, or vestibular function tests. C. No use of prophylactic medication within 2 weeks prior to baseline. D. Provided written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients whose dizziness and headache are determined to be caused by an underlying central nervous system disorder or other identifiable medical conditions. Patients with clinically significant medical conditions (e.g., liver disease, kidney disease, malignancies) that, in the investigator’s judgment, would make study participation difficult. Patients who have difficulty understanding or expressing themselves, making it challenging to participate in the study. Patients who require continuous use of analgesics due to severe pain. Patients for whom the planned prophylactic medication is contraindicated based on specific safety criteria. Patients who, at the investigator’s discretion, are otherwise deemed unsuitable for study participation. Patients who do not provide informed consent. Pregnant women.

Design outcomes

Primary

MeasureTime frame
Headache Frequency

Secondary

MeasureTime frame
Wong-Baker Pain Rating Scale (PRS);Headache Impact Test-6 (HIT-6), Migraine Disability Assessment Questionnaire (MIDAS);Visual Analogue Scale-Dizziness (VAS-D), Dizziness Handicap Inventory (DHI) , UCLA-Dizziness Questionnaire (UCLA-DQ)

Countries

Korea, Republic of

Contacts

Public Contactseo young choi

Pusan National University Hospital

csy035@hanmail.net+82-51-240-7085

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 21, 2026