Migraine
Conditions
Interventions
Treatment group:HMI-115, 240 mg - Given subcutaneously once every two weeks
Control group:Placebo (HMI-115 mock lyophilization) - given subcutaneously once every two weeks
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged between 18 and 60 years; 2. Meets the diagnostic criteria for migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3, 2018); 3. History of migraine for at least one year; 4. An average of 4 to 14 migraine days per month (defined as a 28-day period) during the 3 months prior to screening, with no more than 14 total headache days per month (regardless of whether the headaches are migraine-related); 5. Able to understand the investigator’s instructions accurately and capable of completing a headache diary independently or with the assistance of a caregiver; 6. Willing and able to voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Systematic use of other preventive treatments for migraine (e.g., ß-blockers, calcium channel blockers, antiepileptic drugs, antidepressants, or 5-HT receptor antagonists) within the past 3 months; 2. Diagnosed with medication-overuse headache or other specific types of migraine (e.g., ophthalmoplegic migraine, hemiplegic migraine, etc.); 3. History of pituitary or hypothalamic tumors, or current hyperprolactinemia; 4. Current alcohol and/or other substance abuse; 5. Coexisting severe central nervous system diseases, such as acute cerebrovascular disorders, intracranial tumors, intracranial infections, or progressive neurological diseases; 6. Severe psychiatric disorders, such as schizophrenia, bipolar disorder, major depression, or significant anxiety disorders; 7. Severe dysfunction of major organs (heart, lungs, liver, kidneys, etc.), or any condition which, in the investigator's judgment, may put the participant at risk, affect the study outcomes, or impair the participant’s ability to comply with the study procedures; 8. Known hypersensitivity to the investigational product or drugs of the same class; 9. Pregnant or breastfeeding women, or women planning to become pregnant during the study period; 10. Participation in another interventional clinical trial within 3 months prior to signing the informed consent, currently participating in another interventional trial, or planning to do so during the study period; or planning to travel or relocate during the study, thereby making follow-up impractical; 11. Any other condition that, in the opinion of the investigator, renders the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the mean number of monthly migraine days from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of migraine attacks;The degree of headache;Dosage of acute analgesic;Headache Impact Test (HIT-6) score;Migraine-specific Quality of Life Questionnaire (MSQ 2.1) score;Proportion of patients with complete absence of migraine attacks;Average duration of headache; | — |
Countries
China
Contacts
Public ContactLei Chen
West China Hospital, Sichuan University
Outcome results
None listed