An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.

NCT ID: NCT04665323

Last Updated: 2021-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

411 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-18

Study Completion Date

2021-04-30

Brief Summary

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The FOP burden of illness (BoI) survey aims to assess the impact of the burden of FOP on patients and their families. The study is being conducted online and available for residents in Argentina, Brazil, Canada, France, Germany, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Sweden, the US, and the UK.

Detailed Description

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Conditions

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Fibrodysplasia Ossificans Progressiva

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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People living with FOP

No interventions assigned to this group

Parent or legal guardian primary caregivers

No interventions assigned to this group

Parent or legal guardian

No interventions assigned to this group

Siblings

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Individuals meeting one of the two categories below (A or B) are eligible to participate: A. Any individual with FOP, of any age; B. Any individual who is a family member of a person with FOP (i.e. either a parent / legal guardian or a sibling) and who is aged 18 years and older
2. All adult participants and parents / legal guardians of minors should provide informed consent before starting filling out the survey

Exclusion Criteria

1\. Any individuals who are unable to complete the online survey independently or to get assistance to physically enter the answers
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Ipsen Central Contact

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CLIN-60120-450

Identifier Type: -

Identifier Source: org_study_id

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