The Impact of Migraine on Canadians' Productivity: A Real-World Pharmacy-Based Study

Completed

• Conditions: Migraine
• Interventions: Drug: observational study

• Registration Number: NCT05556564
• Lead Sponsor: PeriPharm

Brief Summary

This is a cross-sectional, real-world observational, community pharmacy-based study in which adults treated with a triptan for their migraine will self-report productivity and activity impairment using a web-based portal or paper-based questionnaire.

Detailed Description

The primary objective of this study is to estimate the productivity and activity impairment associated with migraine in adults treated with a triptan.

Participant identification will be made using pharmacies member of the PROxy Network. Eligible participants will be identified using the prescription of any formulation of triptans either when filling or refilling a prescription of a triptan or in the pharmacy electronic database (patients with a renewal in the last 3 months).

The PROxy Network is a research network bringing together community pharmacies across Quebec to facilitate the generation of real-world evidence. This network is designed to better understand a disease or a treatment using patient-reported outcomes (PROs). The PROxy Network is an initiative of PeriPharm Inc., a company specializing in pharmacoeconomics and outcomes research.

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-27
• Study Start: 2022-10-31
• Primary Completion: 2023-03-06
• Study Completion: 2023-03-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 18 years of age or older;
• New or current prescription (renewal in the last 3 months) of any formulation of triptans medication (i.e., almotriptan, eletriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan and frovatriptan);
• Working full or part-time or going to school full or part-time;
• Ability to read and understand English or French;
• Signature of informed consent form (ICF).

Exclusion Criteria

• Patients participating in a clinical trial.
• Patients filling a one-time vacation/emergency prescription (i.e. without a complete pharmacy file).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No group	observational study	-

Primary Outcome Measures

Name	Time	Method
The Migraine Disability Assessment (MIDAS) questionnaire	Baseline	Patient-reported outcome: The Migraine Disability Assessment (MIDAS) is a 5-item, self-administered questionnaire designed to quantify headache-related disability over the past 3 months. The MIDAS is scored as the sum of five questions, each measured as days in the last 3 months, and then categorized into four disability grades with higher scores indicating greater disability: ''Grade I - Little to no disability'' for 0 to 5 days, ''Grade II - Mild disability'' for 6 to 10 days, ''Grade III - Moderate disability'' for 11 to 20 days and ''Grade IV - Severe disability'' for 21 days and over.

Trial Locations

Locations (1)

PROxy Network, an initiative of PeriPharm inc.; 🇨🇦 Montreal, Quebec, Canada