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Evaluation of cortisone treatment in children suffering from acute facial nerve paralysis.
EU CTIS ID: 2024-513430-37-00
What this study is testing
To evaluate the efficacy of cortisone versus placebo treatment in children with acute facial nerve palsy, measured as total recovery with the House-Brackmann scale at 12 months follow-up.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1-17 years of age
- Acute peripheral facial nerve palsy
- Less than 72 hours of duration of symptoms
- Signed informed consent.
You likely can't join if
- Trauma
- Use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms
- Immunization with live vaccine 1 month prior onset of symptoms
- Requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo)
- Evaluation of primary endpoint at 12 months not feasible for any reason
- Previously included into the FACE study
See the full eligibility criteria
- 1-17 years of age
- Acute peripheral facial nerve palsy
- Less than 72 hours of duration of symptoms
- Signed informed consent.
- Trauma
- Use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms
- Immunization with live vaccine 1 month prior onset of symptoms
- Requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo)
- Evaluation of primary endpoint at 12 months not feasible for any reason
- Previously included into the FACE study
- Central facial nerve palsy
- Malformations in head and neck
- Conditions not compatible with cortisone treatment (hypertension, diabetes mellitus type 1, psychiatric disorder, active or latent tuberculosis, intolerance of lactose)
- Current or past oncological diagnosis
- Other serious medical conditions (meningitis, encephalitis, stroke)
- Acute otitis media
- Signs of herpes simplex or varicella zoster infection (vesicles in the ear region)
- Pregnancy or breastfeeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.