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

Sponsor

Silvia Benemei (Other)

Overall Status

Recruiting

CT.gov ID

NCT03416114

Collaborator

University of Modena and Reggio Emilia (Other), University of Roma La Sapienza (Other), University of Naples (Other), University of Trieste (Other), Maggiore Bellaria Hospital, Bologna (Other), University of L'Aquila (Other)

3,000

Enrollment

Location

119

Anticipated Duration (Months)

25.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Headache Disorders

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Sep 1, 2017

Anticipated Primary Completion Date :

Aug 1, 2027

Anticipated Study Completion Date :

Aug 1, 2027

Outcome Measures

Primary Outcome Measures

Incidence and prevalence in Tertiary headache Centres [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Careggi University Hospital	Florence		Italy	50139

Sponsors and Collaborators

Silvia Benemei
University of Modena and Reggio Emilia
University of Roma La Sapienza
University of Naples
University of Trieste
Maggiore Bellaria Hospital, Bologna
University of L'Aquila

Investigators

Study Chair: Silvia Benemei, MD, Careggi University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Silvia Benemei, Researcher, University of Florence

ClinicalTrials.gov Identifier:

NCT03416114

Other Study ID Numbers:

RegistRare

First Posted:

Jan 30, 2018

Last Update Posted:

Jan 30, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Silvia Benemei, Researcher, University of Florence

rare headaches

epidemiology

Additional relevant MeSH terms:

Headache Disorders

Headache

Study Results

No Results Posted as of Jan 30, 2018