migraine
Conditions
Interventions
Episodic migraine cohort on erenumab (Cohort A):N/A
Chronic migraine cohort on erenumab (Cohort C):N/A
Sponsors
Guangzhou United Family Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1 Cohort of patients with episodic migraine using Erenumab (Cohort A) Eligibility criteria: Enrolled patients should meet all of the following criteria Patients signed informed consent before enrollment; Patients were required to be between 18 and 65 years of age at enrollment or index date; 5 or more previous migraine attacks with or without aura as demonstrated by medical records or patient complaints according to the migraine diagnostic criteria ICHD-3; According to data collected in the database, patient headache diaries, and patient complaints, migraine days per month ranged from 4 to 14 days and headache days per month were less than 15 days at the index date or 3 months before study initiation; Previous use of 2 or more prophylactic medications has failed; Erenumab treatment from index date; Allowed in combination with up to one other preventive treatment that has been in use for at least one month prior to the index date. 2 Cohort of patients with chronic migraine using Erenumab (Cohort B) Inclusion criteria: Enrolled patients should meet all of the following criteria Patients signed informed consent before enrollment; Patients were required to be between 18 and 65 years of age at enrollment or index date; Met the diagnostic criteria for chronic migraine ICHD-3; According to data collected in the database, patient headache diaries, and patient complaints, more than 15 headache days per month were reported on the index date or 3 months before study initiation, with more than 8 headache days being eligible for migraine; Previous use of 2 or more prophylactic medications has failed; Erenumab treatment from index date.
Exclusion criteria
Exclusion criteria: 1 Cohort of patients with episodic migraine using Erenumab (Cohort A) Exclusion criteria: Patients who met any of the following criteria were not included A diagnosis of cluster or hemiplegic migraine, chronic migraine with persistent pain, or migraine that cannot be distinguished from other headaches; Patients who have received anti-CGRP therapy (small molecule or monoclonal antibody) or participated in clinical trials of anti-CGRP drugs on or before the index date; Patients treated with botox in the head and/or neck; Patients with less than 80% compliance (less than 23 days per 4 weeks) to fill in the patient headache diary according to prestudy follow-up data; Patients for whom baseline data are difficult to collect; Patients whose combination of other prophylactic medications changed from the index date to the start of the study. 2 Cohort of patients with chronic migraine using Erenumab (Cohort B) Exclusion criteria: Patients who met any of the following criteria were not included A diagnosis of cluster or hemiplegic migraine, chronic migraine with persistent pain, or migraine that cannot be distinguished from other headaches; Patients who have received anti-CGRP therapy (small molecule or monoclonal antibody) or participated in clinical trials of anti-CGRP drugs on or before the index date; Patients treated with botox in the head and/or neck; Patients with less than 80% compliance (less than 23 days per 4 weeks) according to prestudy follow-up data; Patients for whom baseline data are difficult to collect; Patients whose combination of other prophylactic medications changed from the index date to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a 50% or greater reduction in MMDs from baseline at week 12 after starting erenumab; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction and percentage reduction in MMDs from baseline at week 4 after starting erenumab;Reduction and percentage reduction in MMDs from baseline at week 12 after starting erenumab;Reduction and percentage reduction in monthly days of use of acute analgesic medication (tretinoin, ergots, barbiturates, opioids, serotonin 1F agonist, or non-steroidal anti-inflammatory drugs (NSAIDs)) from the baseline at week 12 after starting erenumab;Adverse events and serious adverse events within 12 weeks after starting erenumab;Change from baseline in Headache (Migraine) Efficacy Rating Scale, Migraine-Specific Quality of Life Questionnaire (MSQ2.1), Headache Impact Test (HIT-6) score, and Migraine Disability Assessment (MIDAS) at week 12 after starting erenumab; | — |
Countries
China
Contacts
Public Contactzhonglin LIU
Guangzhou United Family Hospital
Outcome results
None listed