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OpenTrials
Completed

NCT Number: NCT05556564

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

PROxy Network, an initiative of PeriPharm inc.

Montreal, Quebec, H2Y 2H4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Observational Study

Drug

No intervention, observational study

Primary outcomes

  1. The Migraine Disability Assessment (MIDAS) questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

PeriPharm

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2022
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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