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

Headache Disorders Clinical Trial

— RegistRare  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03416114
• Other study ID #: RegistRare
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2018
• Last updated: January 23, 2018
• Start date: September 1, 2017
• Est. completion date: August 2027

Study information

• Verified date: January 2018
• Source: University of Florence
• Contact: Silvia Benemei, MD
• Phone: 00393452842070
• Email: silvia.benemei[@]unifi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• signed informed consent

Exclusion Criteria:

Related Conditions & MeSH terms

• Headache
• Headache Disorders

Locations

Country	Name	City	State
Italy	Careggi University Hospital	Florence

Sponsors (7)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and prevalence in Tertiary headache Centres		10 years