NCT05995288

Brief Summary

Periodic fever, aphthous stomatitis, pharyngitis, cervical adenitis (PFAPA) syndrome is frequently diagnosed in young children. Fevers recurring at a nearly predictable rate every three to eight weeks are the signature symptom of PFAPA syndrome. PFAPA is an acquired autoinflammatory disorder, which recurs in association with at least one sign of aphthous stomatitis, pharyngitis, and cervical lymph node enlargement. The aim of this retrospective case report is to gain an impression of the course of disease during individualized homeopathic treatment in children suffering from PFAPA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

1.7 years

First QC Date

August 9, 2023

Last Update Submit

August 15, 2023

Conditions

Periodic Fever Syndrome

Keywords

PFAPAperiodic feverhomeopathyNaranjo criteria

Outcome Measures

Primary Outcomes (1)

  • Periodic fever flares

    Appearance of periodic fever flares

    30 months

Study Arms (1)

Children suffering from PFAPA

Children suffering from periodic fever, with at least one of the following symptoms: aphthous stomatitis, pharyngitis, cervical adenitis

Drug: Homeopathic Globule

Interventions

Homeopathic GlobuleDRUG

Homeopathic globules were administered after careful anamnesis

Children suffering from PFAPA

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children were suffering from PFAPA for at least 6 months.

You may qualify if:

  • Children suffering from fever with at least one of the symptooms of PFAPA besides fever

You may not qualify if:

  • Parents not willing to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael Frass

Vienna, 1100, Austria

Location

MeSH Terms

Conditions

Hereditary Autoinflammatory Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Peter Panhofer, MD

    Sigmund Freud Private University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 16, 2023

Study Start

May 1, 2019

Primary Completion

December 31, 2020

Study Completion

August 8, 2023

Last Updated

August 18, 2023

Record last verified: 2023-08

Locations

AU(1)