Cluster HeadacheNCT05978258
A Close Examination of Patient Experiences in Cluster Headache Clinical Research
An observational study of Cluster Headache, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
Historically, participation in clinical studies is highly skewed towards particular demographic groups of people. This research will invite several participants to gather a wide range of information on clinical trial experiences for cluster headache patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cluster Headache
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cluster headache who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.
Who may be able to join
- Patient has been diagnosed with cluster headache
- Patient has access to a home internet connection in order to provide regular updates through the course of the study
- Participant must be 18 years of age or older
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
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: An Observational Study Assessing the Experience of Patients Undergoing Active Cluster Headache Clinical Trials
Historically, participation in clinical studies is highly skewed towards particular demographic groups of people.
This research will invite several participants to gather a wide range of information on clinical trial experiences for cluster headache 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 cluster headache.
The data collected from this study will help improve future outcomes for all cluster headache patients as well as those in under-represented demographic groups.
- Conditions
- Cluster Headache
- Keywords
- Cluster Headache
- Medical subject headings
- Cluster Headache
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in a cluster headache clinical study.
Measured: 3 months
Number of cluster headache patients who remain in clinical research until 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 posted7 Aug 2023
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (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 Cluster HeadacheStudies 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
- NCT05978258
- Sponsor's protocol ID
- 81829797
- Status last verified
- Jul 2023
- First submitted
- 28 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Merli E, Asioli GM, Favoni V, Zenesini C, Mascarella D, Sartori A, Cortelli P, Cevoli S, Pierangeli G. Great occipital nerve long-acting steroid injections in cluster headache therapy: an observational prospective study. J Neurol. 2022 Apr;269(4):2193-2199. doi: 10.1007/s00415-021-10884-0. Epub 2021 Nov 25.
PubMed 34820736Snoer A, Lund N, Beske R, Hagedorn A, Jensen RH, Barloese M. Cluster headache beyond the pain phase: A prospective study of 500 attacks. Neurology. 2018 Aug 28;91(9):e822-e831. doi: 10.1212/01.wnl.0000542491.92981.03. Epub 2018 Jul 27.
PubMed 30054443Vigano A, Savastano E, Petolicchio B, Toscano M, De Sanctis R, Maestrini I, Di Piero V. A Study of Clinical Features and Risk Factors of Self-Referring Emergency Department Headache Patients: A Comparison with Headache Center Outpatients. Eur Neurol. 2020;83(1):34-40. doi: 10.1159/000505915. Epub 2020 Mar 10.
PubMed 32155625
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Assessing the Experience of Patients Undergoing Active Cluster Headache Clinical Trials
- ClinicalTrials.gov ID
- NCT05978258
- Acronym / sponsor ID
- 81829797
- Conditions
- Cluster Headache
- Keywords
- Cluster Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 7 Aug 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.
Historically, participation in clinical studies is highly skewed towards particular demographic groups of people.
This research will invite several participants to gather a wide range of information on clinical trial experiences for cluster headache 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 cluster headache.
The data collected from this study will help improve future outcomes for all cluster headache patients as well as those in under-represented demographic groups.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cluster headache who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.
Key inclusion criteria (3 listed)
- Patient has been diagnosed with cluster headache
- Patient has access to a home internet connection in order to provide regular updates through the course of the study
- Participant must be 18 years of age or older
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
Rate of patients who decide to enroll in a cluster headache clinical study.
Time frame: 3 months
Number of cluster headache patients who remain in clinical research until completion.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Background: PubMed 34820736Merli E, Asioli GM, Favoni V, Zenesini C, Mascarella D, Sartori A, Cortelli P, Cevoli S, Pierangeli G. Great occipital nerve long-acting steroid injections in cluster headache therapy: an observational prospective study. J Neurol. 2022 Apr;269(4):2193-2199. doi: 10.1007/s00415-021-10884-0. Epub 2021 Nov 25.
- Background: PubMed 30054443Snoer A, Lund N, Beske R, Hagedorn A, Jensen RH, Barloese M. Cluster headache beyond the pain phase: A prospective study of 500 attacks. Neurology. 2018 Aug 28;91(9):e822-e831. doi: 10.1212/01.wnl.0000542491.92981.03. Epub 2018 Jul 27.
- Background: PubMed 32155625Vigano A, Savastano E, Petolicchio B, Toscano M, De Sanctis R, Maestrini I, Di Piero V. A Study of Clinical Features and Risk Factors of Self-Referring Emergency Department Headache Patients: A Comparison with Headache Center Outpatients. Eur Neurol. 2020;83(1):34-40. doi: 10.1159/000505915. Epub 2020 Mar 10.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Michael B Gill study director
Power Life Sciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster Headache, run by Power Life Sciences Inc. at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Rate of patients who decide to enroll in a cluster headache clinical study. (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 NCT05978258, 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 7 Aug 2023.