Study identification

EU PAS number

EUPAS50402

Study ID

50403

Official title and acronym

A Long-Term Observational, Retrospective Cohort Study to Evaluate the Safety, Including Cardiovascular Safety, of Fremanezumab in Patients with Migraine in Routine Clinical Practice in the United States and Europe

DARWIN EU® study

No

Study countries

Germany
United States

Study description

The study will investigate the incidence of adverse events in a real world setting in migraine patients with long-term exposure to fremanezumab relative to migraine patients treated with other preventive migraine pharmacotherapy. The objectives of the study are to evaluate: the long-term safety of fremanezumab in patients with migraine, the safety of fremanezumab in a sub population of CV compromised patients and the incidence of new-onset hypertension and worsening of preexisting hypertension in fremanzumab treated patients. This is a retrospective, comparative, controlled, claims and EHR database study. The study population consists of patients with a diagnosis of migraine whose data were recorded in claims databases (Germany) and an EHR database linked to claims (US). The study period will be defined from 3 years before the country-specific launch date of fremanezumab to the most recent data available in each database at the end of 2026. Patients will be enrolled in the study from the country-specific launch date of fremanezumab until 12 months before the most recent data available at the end of 2026 to allow at least 12 months of follow-up for the patients. The long-term use will be investigated in patients with persistent treatment of the drug of interest for at least 3 years with at least 80% adherence. Demographic and medical information, comorbidities, and concomitant medications during the pre-index period will be examined. Use of medications for the preventive treatment of migraine, CV disease, hypertension, and other chronic medical conditions will be collected. Comparisons of the proportions of AEs in fremanezumab and comparative cohorts will be evaluated through a multivariable model with propensity scores used as inverse probability of treatment weighting. The incidence rate ratios of patients observed with worsening of hypertension or with a new documentation of a diagnostic code for hypertension post index date will be calculated for all cohorts.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Natan Kahan

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Teva Branded Pharmaceutical Products R&D, Inc
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)