Headache DisordersRegistRareNCT03416114
RegistRare: a Retro-prospective Registry of Rare Primary Headaches in Italian Tertiary Headache Centres
An observational study of Headache Disorders, run by Silvia Benemei at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Headache Disorders
- How many people
- 3,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2017to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- diagnosis of rare primary headaches (Part One, Chapter 3 and Chapter 4, ICHD-3 beta)
- signed informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Careggi University Hospital
Florence, 50139
Silvia Benemei, MD
Chiara Lupi, MD
About this study
Official title: RegistRare: a Retro-prospective Registry of Rare Primary Headaches in Italian Tertiary
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.
- Conditions
- Headache Disorders
- Keywords
- rare headaches, epidemiology
- Medical subject headings
- Headache Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and prevalence in Tertiary headache Centres
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Sep 2017
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silvia Benemei
- Sponsor type
- University, hospital or other
- 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
- Sponsor-investigator, Silvia Benemei, University of Florence
- Investigators
- Silvia Benemei, MD, Study chair, Careggi University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416114
- Sponsor's protocol ID
- RegistRare
- Acronym
- RegistRare
- Status last verified
- Jan 2018
- First submitted
- 23 Jan 2018
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RegistRare: a Retro-prospective Registry of Rare Primary Headaches in Italian Tertiary
- ClinicalTrials.gov ID
- NCT03416114
- Acronym / sponsor ID
- RegistRare / RegistRare
- Conditions
- Headache Disorders
- Keywords
- rare headaches, epidemiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Silvia BenemeiUniversity, hospital or other
- 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
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- diagnosis of rare primary headaches (Part One, Chapter 3 and Chapter 4, ICHD-3 beta)
- signed informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence and prevalence in Tertiary headache Centres
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Derived from this study: PubMed 29754500Lupi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia Benemei, MD study chair
Careggi University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache Disorders, run by Silvia Benemei at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Benemei, MD (00393452842070, silvia.benemei@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and prevalence in Tertiary headache Centres (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03416114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.