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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

From the registry’s dates

  • Started Sep 2017; still recruiting 9 years 2 months later.
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

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Keywords

  • rare headaches
  • epidemiology
03

In context

Headache Disorders

145 studies on the registry are indexed under Headache Disorders; 37 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 131 across 46 observational studies indexed under Headache Disorders.

Browse Headache Disorders studies →

Lead sponsor

This is the only study on the registry with Silvia Benemei as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
3,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Incidence and prevalence in Tertiary headache Centres

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Careggi University Hospital
    Florence, 50139, Italy
    Recruiting
    • Silvia Benemei, MD · Contact
    • Chiara Lupi, MD · Sub investigator
08

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

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2017 (actual). Primary completion is estimated for Aug 2027, 119 months after the start.

Of 21 observational studies under Headache Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15. This study's planned 119 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2018
First posted
Jan 30, 2018
StartActual
Sep 1, 2017
Primary completionEst.
Aug 2027
CompletionEst.
Aug 2027
Last update
Jan 30, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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