Exploring Clinical Trial Experiences of Patients With Migraine

February 23, 2024 updated by: Power Life Sciences Inc.

An In Depth Study Examining Patterns in the Clinical Trial Experiences of Migraine Patients

Clinical study participation has historically been heavily biased toward specific demographics.

This study will invite several participants to gather a wide range of information on clinical trial experiences for migraine patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of migraine.

People with migraine who are invited to take part in medical research will benefit from the analysis of the data.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with migraine who are actively considering enrolling in an interventional clinical trial for said condition, but have not yet completed enrollment and randomization phases in said clinical trial.

Description

Inclusion Criteria:

  • Patient is a minimum of 18 years of age
  • Patient has been diagnosed with a type of migraine
  • Patient plans to participate in an interventional clinical trial for the condition of migraine
  • Patient has access to a home internet connection in order to provide regular updates through the course of the study

Exclusion Criteria:

  • Patient has an ECOG score of 4 or higher
  • Patient is not able to provide consistent digital updates as per study requirements
  • Patient does not complete or agree to terms outlined in the Informed Consent Form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who decide to enroll in a migraine clinical trial
Time Frame: 3 months
3 months
Rate of patients who remain in migraine clinical trial to trial completion
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Power Life Sciences Inc.

Investigators

  • Study Director: Michael B Gill, Power Life Sciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

December 29, 2022

First Submitted That Met QC Criteria

December 29, 2022

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81287400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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