Exploring Clinical Trial Experiences of Patients With Migraine

NCT05675189 | Not Yet Recruiting

• 1 other identifier: 81287400
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Migraine; Migraine Disorders

Keywords

Migraine

Outcome Measures

Primary Outcomes (2)

• Number of patients who decide to enroll in a migraine clinical trial

  3 months

• Rate of patients who remain in migraine clinical trial to trial completion

  12 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• Peters GL. Migraine overview and summary of current and emerging treatment options. Am J Manag Care. 2019 Jan;25(2 Suppl):S23-S34.

  PMID: 30681821 BACKGROUND

• Tfelt-Hansen P. Understanding clinical trials in migraine. J Headache Pain. 2006 Apr;7(2):101-8. doi: 10.1007/s10194-006-0278-2. Epub 2006 Mar 31.

  PMID: 16575501 BACKGROUND

• Solomon S. Selection of patients for clinical drug trials in migraine. Neuroepidemiology. 1987;6(4):164-71. doi: 10.1159/000110115.

  PMID: 3317096 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

(415) 900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 9, 2023
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 26, 2024

Record last verified: 2024-02