RegistRare: a Retro-prospective Registry of Rare Primary Headaches in Italian Tertiary Headache Centres

NCT ID: NCT03416114

Last Updated: 2018-01-30

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

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2027-08-31

Brief Summary

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Retro-prospective survey on specific and overall prevalence and incidence of rare primary headaches (Part One, Chapter 3 and Chapter 4, ICHD-3 beta) in patients referred to Italian Tertiary Headache Centres in a 3-year (May 1, 2014-April 30, 2017 - retrospective data) and annually (from May 1, 2017 - prospective data).

Detailed Description

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We planned to collect data from May 1, 2014 and afterwards, by means of both retrospective and prospective approaches.

All patients who have received or will receive a diagnosis of rare primary headache will be asked to participate and, to this aim, to give their informed consent. Each participating Centre should have received the approval of the competent Ethics Committee before commencing any study procedures.

The registry will contain anagraphic information and data about diagnosis, treatment, comorbidity, and clinical features of the headache. Patients' data will be coded through the Italian Health System unique identifier, in order to avoid duplications of patients referring to more than one Centre and also to monitor multiple referrals.

A web-based open source platform (SurveyMonkey.org) will be used to collect data.

Conditions

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Headache Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis of rare primary headaches (Part One, Chapter 3 and Chapter 4, ICHD-3 beta)
* signed informed consent

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Modena and Reggio Emilia

OTHER

Sponsor Role collaborator

University of Roma La Sapienza

OTHER

Sponsor Role collaborator

University of Naples

OTHER

Sponsor Role collaborator

University of Trieste

OTHER

Sponsor Role collaborator

Maggiore Bellaria Hospital, Bologna

OTHER

Sponsor Role collaborator

University of L'Aquila

OTHER

Sponsor Role collaborator

Silvia Benemei

OTHER

Sponsor Role lead

Responsible Party

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Silvia Benemei

Researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Silvia Benemei, MD

Role: STUDY_CHAIR

Careggi University Hospital

Locations

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Careggi University Hospital

Florence, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Silvia Benemei, MD

Role: CONTACT

00393452842070

Facility Contacts

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Silvia Benemei, MD

Role: primary

References

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Lupi C, Evangelista L, Favoni V, Granato A, Negro A, Pellesi L, Ornello R, Russo A, Cevoli S, Guerzoni S, Benemei S. Rare primary headaches in Italian tertiary Headache Centres: Three year nationwide retrospective data from the RegistRare Network. Cephalalgia. 2018 Jul;38(8):1429-1441. doi: 10.1177/0333102418768824. Epub 2018 May 12.

Reference Type DERIVED
PMID: 29754500 (View on PubMed)

Other Identifiers

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RegistRare

Identifier Type: -

Identifier Source: org_study_id

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