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Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults

Study acronym: BIOFIPS
StatusUnknown
PhaseNot specified
Started2023-01-03
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 20, 2024 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
minor
Trial status changed: Recruiting → Unknown
2024-08-19
minor
Study Status v5
Trial statusRecruiting→Unknown
Primary completion date2024-08→2026-07
Completion date2024-08→2026-07
2024-05-24
minor
Study Status v4
Re-verified, no change to tracked fields
2023-03-10
minor
Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 1 site
2023-01-09
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-07→2024-08
Completion date2024-07→2024-08
Start dateestimated 2022-11→confirmed 2023-01-03
Study sites0→1
2022-11-10
minor
Study Status, Eligibility v1
Start date2022-10→2022-11
Eligibility criteria+73 characters
[...] eraphy (2 times per week along with everyday self-theraphy) Pregnancy or breastfeeding Participation to another interventional study Patient unaffiliated to French Social Security regime Patien [...]
2022-10-13
minor
Original filing
Bell's palsy (idiopathic peripheral facial palsy) is the most common cause of facial palsy, which is related to the inflammation of the facial nerve, possibly induced by herpesvirus reactivation. Its first-line treatment comprises corticosteroids, antiviral therapy and physiotherapy. In most severe cases (grade IV to VI on House-Brackmann scale), facial motricity may remain altered or develop synkinesis or post-paralytic spasm, thus tremendously affecting quality of life. To avoid potential complications, surgical facial nerve decompression could be proposed. To date, however, there are no means to predict if Bell's palsy will evolve with any complications or if the patient will recover entirely. Thus, the invasive facial nerve decompression is equally proposed to subjects who will develop the consequences as well as to subjects able to restore without surgical treatment. This study proposes to search for prognostic blood biomarkers related to the Bell's palsy recovery pattern. Adult patients with severe Bell's palsy will be proposed to have a blood sampling for proteomic analysis in the early stage of the disease. Then 125 biomarkers on a Peptiquant™ kit will be analysed by mass spectrometry, and prognostic biomarkers will be selected regarding to the clinical recovery of Bell's palsy
Trial Details
NCT Number NCT05582915
Lead Sponsor University Hospital, Montpellier
Conditions Bell Palsy
Enrollment 130 participants
Start Date 2023-01-03
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2024-08-20