NCT03416114

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Sep 2017Aug 2027

Study Start

First participant enrolled

September 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

9.9 years

First QC Date

January 23, 2018

Last Update Submit

January 23, 2018

Conditions

Headache Disorders

Keywords

rare headachesepidemiology

Outcome Measures

Primary Outcomes (1)

  • Incidence and prevalence in Tertiary headache Centres

    10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Careggi University Hospital

Florence, 50139, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29754500DERIVED

MeSH Terms

Conditions

Headache Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Silvia Benemei, MD

    Careggi University Hospital

    STUDY CHAIR

Central Study Contacts

Silvia Benemei, MD

CONTACT

00393452842070silvia.benemei@unifi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 30, 2018

Study Start

September 1, 2017

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

IT(1)