MigraineNCT05675189
Exploring Clinical Trial Experiences of Patients With Migraine
An observational study of Migraine and Migraine Disorders, run by Power Life Sciences Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Migraine Disorders
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Migraine, Migraine Disorders
- Keywords
- Migraine
- Medical subject headings
- Migraine Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who decide to enroll in a migraine clinical trial
Measured: 3 months
Rate of patients who remain in migraine clinical trial to trial completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675189
- Sponsor's protocol ID
- 81287400
- Status last verified
- Feb 2024
- First submitted
- 29 Dec 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peters GL. Migraine overview and summary of current and emerging treatment options. Am J Manag Care. 2019 Jan;25(2 Suppl):S23-S34.
PubMed 30681821Tfelt-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.
PubMed 16575501Solomon S. Selection of patients for clinical drug trials in migraine. Neuroepidemiology. 1987;6(4):164-71. doi: 10.1159/000110115.
PubMed 3317096
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In Depth Study Examining Patterns in the Clinical Trial Experiences of Migraine Patients
- ClinicalTrials.gov ID
- NCT05675189
- Acronym / sponsor ID
- 81287400
- Conditions
- Migraine, Migraine Disorders
- Keywords
- Migraine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who decide to enroll in a migraine clinical trial
Time frame: 3 months
Rate of patients who remain in migraine clinical trial to trial completion
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 30681821Peters GL. Migraine overview and summary of current and emerging treatment options. Am J Manag Care. 2019 Jan;25(2 Suppl):S23-S34.
- Background: PubMed 16575501Tfelt-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.
- Background: PubMed 3317096Solomon S. Selection of patients for clinical drug trials in migraine. Neuroepidemiology. 1987;6(4):164-71. doi: 10.1159/000110115.
- Individual participant dataSharing planned: Undecided
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Migraine Disorders, run by Power Life Sciences Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill ((415) 900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who decide to enroll in a migraine clinical trial (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05675189, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.