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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05556564
• Other study ID #: PROxy202201
• Status: Completed
• Start date: October 31, 2022
• Est. completion date: March 6, 2023

Study information

• Verified date: April 2023
• Source: PeriPharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 6, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• observational study
No intervention, observational study

Locations

Country	Name	City	State
Canada	PROxy Network, an initiative of PeriPharm inc.	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
PeriPharm

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Migraine Disability Assessment (MIDAS) questionnaire	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.	Baseline