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Study on Betamethasone Sodium Phosphate for Treating Acute Facial Nerve Palsy in Children

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for children with Facial Nerve Palsy, commonly known as Bell's Palsy. This condition causes sudden weakness or paralysis of the muscles on one side of the face. The study will evaluate the use of a medication called Prednisolone, which is a type of cortisone, to see if it helps improve recovery in affected children. Some participants will receive Prednisolone, while others will receive a placebo, which looks like the medication but does not contain the active substance.

The purpose of the study is to determine how effective cortisone treatment is compared to a placebo in helping children recover from acute facial nerve palsy. Participants in the study will be monitored over a period of 12 months to assess their recovery using a scale called the House-Brackmann scale, which measures the degree of facial nerve function. The study will also look at recovery rates at 1 month and 12 months using another scale called the Sunnybrook grading scale, as well as evaluate the impact of the condition on daily life through various questionnaires.

Throughout the study, the safety of the treatment will be closely monitored by tracking any adverse events. The trial aims to provide valuable information on whether cortisone can be a beneficial treatment option for children experiencing this condition, potentially leading to improved care and outcomes for young patients with facial nerve palsy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the inclusion criteria: age between 1 and 17 years, experiencing acute facial nerve palsy for less than 72 hours, and providing signed informed consent.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of facial nerve palsy using the House-Brackmann grading scale.

  3. Step 3

    Medication administration

    Participants receive either Prednisolone or a placebo. Prednisolone is administered orally in the form of capsules, with a dosage of 5 mg. The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Follow-up assessments

    Follow-up assessments occur at 1 month and 12 months after the start of the trial. These assessments include evaluations using the House-Brackmann and Sunnybrook grading scales to measure recovery.

    Additional evaluations include the Facial Clinimetric Evaluation (FaCE) scale, the Facial Disability Index (FDI), and the Synkinesis Assessment Questionnaire (SAQ) to assess subjective symptoms and daily life impact.

  5. Step 5

    Safety monitoring

    Throughout the trial, safety is monitored by reporting any adverse events experienced by participants.

  6. Step 6

    Final evaluation

    The primary endpoint is assessed at 12 months, focusing on the number of patients with total recovery of facial nerve palsy as measured by the House-Brackmann grading scale.

Who can join the trial?

4 criteria

  • Children aged between 1 and 17 years old.
  • Must have **acute peripheral facial nerve palsy**. This means a sudden weakness or paralysis of the muscles on one side of the face.
  • Symptoms must have started less than 72 hours ago.
  • A signed **informed consent** is required. This is a document that explains the study and confirms that you agree to participate.

Who cannot join the trial?

6 criteria

  • Children younger than 2 years old cannot participate.
  • Children with other medical conditions that affect the face or nerves may not be eligible.
  • Children who have had previous treatment for facial nerve palsy might be excluded.
  • Children with allergies to cortisone or similar medications cannot join the study.
  • Children who are currently participating in another clinical trial may not be allowed to participate.
  • Children with severe health issues that could interfere with the study may be excluded.
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Investigated drugs

Cortisone is a medication used in this trial to evaluate its effectiveness in treating children with acute facial nerve palsy. It is a type of steroid that helps reduce inflammation and swelling, which may improve nerve function and aid in recovery. The study aims to see if cortisone can help children recover fully from facial nerve palsy over a 12-month period.

What is already known about the treatment

Cortisone – Cortisone is typically administered orally in tablet form or as an injection. It is currently well-established in medical literature as a treatment for various inflammatory conditions. In the context of facial nerve palsy, also known as Bell's Palsy, cortisone is used to reduce inflammation and swelling, potentially aiding in nerve recovery. At the molecular level, cortisone works by suppressing the immune system's response, thereby decreasing inflammation. It is classified as a corticosteroid, a type of steroid hormone that mimics the effects of hormones your body produces naturally in the adrenal glands.

Investigated diseases

Facial Nerve Palsy (Bell's Palsy) – This condition involves sudden weakness or paralysis of the muscles on one side of the face due to dysfunction of the facial nerve. It often results in a drooping appearance on the affected side, difficulty closing the eye, and changes in facial expression. The exact cause is not always clear, but it is sometimes linked to viral infections. Symptoms typically appear suddenly and can range from mild to severe. Over time, most individuals experience gradual improvement, with many recovering fully. The progression of the condition varies, with some people seeing improvement within weeks, while others may take longer.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-513430-37-00Protocol codeFACE-01Estimated enrolment500 patientsSponsorRegion Dalarna

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