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RecruitingNCT03416114RegistRareUpdated Jan 30, 2018

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

An observational study in Headache Disorders, sponsored by Silvia Benemei. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Silvia Benemei · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
3,000
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Headache Disorders

Keywords

  • rare headaches
  • epidemiology
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
3,000 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Incidence and prevalence in Tertiary headache Centres

    Time frame: 10 years

06

Study locations

1 of 1 sites recruiting
  • Careggi University Hospital
    Florence, 50139, Italy
    • Silvia Benemei, MD · Contact
    • Chiara Lupi, MD · Sub investigator
    Recruiting
07

References and documents

Publications

  • 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. PubMed 29754500 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03416114
Lead sponsor
Silvia Benemei
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
Responsible party
Silvia Benemei (Researcher, University of Florence) — Sponsor-investigator
First posted
Jan 30, 2018
Start date
Sep 1, 2017
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Jan 30, 2018

Study contacts

Silvia Benemei, MD
Contact
silvia.benemei@unifi.it
00393452842070
Silvia Benemei, MD
study chair · Careggi University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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