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New treatment option for Facial Palsy
Official title Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
ClinicalTrials.gov ID: NCT03781700
What this study is testing
What is Prednisolone?
Prednisolone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for facial palsy.
Also referred to as Batch 18A71, Orifarm Generics A/S.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Acute facial nerve palsy occur in 10-20/100 000 children/year in Sweden. About 20 % of these children will have persistent symptoms with excessive tear secretion, drooling and social problems due to asymmetry in the face.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- 1-17 years of age
- Acute peripheral unilateral facial nerve palsy
- Less than 72 hours since debut of symptoms
- Signed informed consent
You likely can't join if
- Head trauma \<1 month
- Central or bilateral facial nerve palsy
- Malformations in head and neck
- Conditions not compatible with cortisone treatment (arterial hypertension, diabetes mellitus, psychiatric disorder, active or latent tuberculosis...
- Current or past oncological diagnosis
- Other serious medical conditions (meningitis, encephalitis, stroke)
See the full eligibility criteria
- 1-17 years of age
- Acute peripheral unilateral facial nerve palsy
- Less than 72 hours since debut of symptoms
- Signed informed consent
- Head trauma \<1 month
- Central or bilateral facial nerve palsy
- Malformations in head and neck
- Conditions not compatible with cortisone treatment (arterial hypertension, diabetes mellitus, 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Falun, Dalarna County, Sweden
- Kalmar, Region Kalmar, Sweden
- Skövde, Västra Götalands Region, Sweden
- Gothenburg, Sweden
- Jönköping, Sweden
- Karlskrona, Sweden
- Linköping, Sweden
- Lund, Sweden
- Malmö, Sweden
- Norrköping, Sweden
- Örebro, Sweden
- Solna, Sweden
- Stockholm, Sweden
- Uppsala, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 1 year to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Falun, Dalarna County, Sweden; Kalmar, Region Kalmar, Sweden; Skövde, Västra Götalands Region, Sweden; Gothenburg, Sweden; Jönköping, Sweden; Karlskrona, Sweden and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.