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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05375097
Other study ID # CAMG334AFI03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 3, 2020
Est. completion date May 14, 2021

Study information

Verified date June 2022
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This was a retrospective registry-based study utilizing data collected in association with clinical care of patients. All data was stored in electronic health records at Terveystalo data base, and no patients were contacted for the study.


Description:

Patients initiating erenumab treatment between 20.9.2018 - 15.10. 2019, and data on sick leave days, diagnoses and health care visits as well as medications based on prescriptions were assessed. Following time frames for analyses of sick leaves and health care utilization in patients on erenumab treatment and in controls were reported: Follow-up analyses: For cases (erenumab) with occupational healthcare, a minimum of 12 months on erenumab treatment was required for the analysis of sick leaves and visits Pre erenumab: Follow-up data before index (defined as the first reimbursement decision/prescription for erenumab, or initiation of erenumab injections (before reimbursement approval)) from the Terveystalo database of those with consent Post erenumab: Follow-up data after index, from the Terveystalo database of those with consent Time frames for comparison (sick leaves and visits): One year before index vs. >12 months erenumab after index, One year before index vs. 6-12 months of erenumab after index (patient years), sensitivity analysis Time frames for comparison (medications): 12 months before index vs. 12 months post follow-up Controls (triptan treated migraine patients): Corresponding time frames as in cases.


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date May 14, 2021
Est. primary completion date May 14, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Adult patients on erenumab treatment ATC: N02CX07 - Diagnosis of migraine (ICD G43) - Consented - Occupational healthcare Exclusion Criteria: None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Erenumab
Patients who met the responder definition of two or more erenumab prescriptions with no evidence of switch to other CGRPi were included in the main analyses

Locations

Country Name City State
United States Novartis Investigative Site East Hanover New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of sick leave days (headache) Sick leaves included migraine or head-ache related registered sick leave days at Terveystalo in the occupational healthcare cohort and controls. throughout the study, approximately 2 years
Secondary Change in number of sick leave days (all cause) Sick leaves included all registered sick leave days at Terveystalo in the occupational healthcare cohort and controls. throughout the study, approximately 2 years
Secondary Change in number of healthcare visits (head-ache related) Number of headache related healthcare visits were reported. throughout the study, approximately 2 years
Secondary Change in number of healthcare visits (all cause) Number of healthcare visits were reported. throughout the study, approximately 2 years
Secondary Medication patterns: Number of patients receiving medications of interest The number of patients receiving medications of interest in erenumab treated patients in migraine patient controls were reported. throughout the study, approximately 2 years
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