ClinicalTrials.gg
Not yet recruitingNCT05978258Updated Aug 7, 2023

A Close Examination of Patient Experiences in Cluster Headache Clinical Research

An observational study in Cluster Headache, sponsored by Power Life Sciences Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-07.

Sponsored by Power Life Sciences Inc. · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cluster Headache

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Keywords

  • Cluster Headache
03

In context

Cluster Headache

123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.

This study's planned enrollment of 500 is above the median of 68 across 32 observational studies indexed under Cluster Headache.

Browse Cluster Headache studies →

Lead sponsor

Power Life Sciences Inc. is the lead sponsor of 111 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patient has an 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 Form
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Rate of patients who decide to enroll in a cluster headache clinical study.

    Time frame: 3 months

  2. Number of cluster headache patients who remain in clinical research until completion.

    Time frame: 12 months

07

Study locations

1 site
08

References and documents

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 34820736 ↗
  • Snoer 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 30054443 ↗
  • Vigano 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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2024; primary completion for Aug 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2023
First posted
Aug 7, 2023
StartEst.
Aug 2024
Primary completionEst.
Aug 2025
CompletionEst.
Aug 2026
Last update
Aug 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05978258
Responsible party
Sponsor
First posted
Aug 7, 2023
Start date
Aug 2024 (estimated)
Primary completion
Aug 2025 (estimated)
Completion
Aug 2026 (estimated)
Last update
Aug 7, 2023

Study contacts

Michael B Gill
Contact
bask@withpower.com
(415) 900-4227
Michael B Gill
study director · Power Life Sciences Inc.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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