An Observational Study Assessing the Experience of Patients Undergoing Active Cluster Headache Clinical Trials
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Power Life Sciences Inc.
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Rate of patients who decide to enroll in a cluster headache clinical study.
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Crossover
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported