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

Sponsor
PeriPharm (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05556564
Collaborator
(none)
100
1
3
33.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: observational study

Detailed Description

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

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 through data coming directly from patients using patient-reported outcomes (PROs). The PROxy Network is an initiative of PeriPharm Inc., a company specializing in pharmacoeconomics and outcomes research.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
The Impact of Migraine on Canadians' Productivity: A Real-World Pharmacy-Based Study
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No group

Drug: observational study
No intervention, observational study

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 PROxy Network, an initiative of PeriPharm inc. Montreal Quebec Canada H2Y 2H4

Sponsors and Collaborators

  • PeriPharm

Investigators

  • Principal Investigator: Jean Lachaine, PeriParm inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PeriPharm
ClinicalTrials.gov Identifier:
NCT05556564
Other Study ID Numbers:
  • PROxy202201
First Posted:
Sep 27, 2022
Last Update Posted:
Sep 27, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 27, 2022