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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03416114

Recruitment Status : Recruiting

First Posted : January 30, 2018

Last Update Posted : January 30, 2018

See Contacts and Locations

Sponsor:

Collaborators:

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

Information provided by (Responsible Party):

Silvia Benemei, University of Florence

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
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

Layout table for study information

Study Type :	Observational
Estimated 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 :	September 1, 2017
Estimated Primary Completion Date :	August 2027
Estimated Study Completion Date :	August 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Incidence and prevalence in Tertiary headache Centres [ Time Frame: 10 years ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Retrospective data collection:

Patients referred to Italian Tertiary Headache Centres in a 3-year (May 1, 2014 to April 30, 2017) period

Prospective data collection:

Patients referred to Italian Tertiary Headache Centres after April 30, 2017

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416114

Contacts

Layout table for location contacts

Contact: Silvia Benemei, MD	00393452842070	silvia.benemei@unifi.it

Locations

Layout table for location information

Italy
Careggi University Hospital	Recruiting
Florence, Italy, 50139
Contact: Silvia Benemei, MD
Sub-Investigator: Chiara Lupi, MD

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

Layout table for investigator information

Study Chair:	Silvia Benemei, MD	Careggi University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	Silvia Benemei, Researcher, University of Florence
ClinicalTrials.gov Identifier:	NCT03416114
Other Study ID Numbers:	RegistRare
First Posted:	January 30, 2018 Key Record Dates
Last Update Posted:	January 30, 2018
Last Verified:	January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Silvia Benemei, University of Florence:


rare headaches epidemiology

Additional relevant MeSH terms:

Layout table for MeSH terms

Headache Disorders Headache Pain Neurologic Manifestations	Brain Diseases Central Nervous System Diseases Nervous System Diseases

To Top