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

3 1 1

What is this study about?

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.

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 initial assessment

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

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 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 safety monitoring

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

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Region Vaestmanland Vasteras Sweden

Other Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden
Region Oerebro Laen Orebro Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Region Skane Helsingborg Hospital Helsingborg Sweden
Region Dalarna Falun Sweden
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen Boras Sweden
Skaraborg Hospital-Vaestra Goetalandsregionen Skovde Sweden
Laenssjukhuset I Kalmar Region Kalmar Laen Kalmar Sweden
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland Norrkoping Sweden
Region Blekinge Karlskrona Sweden
Region Skane Skanes Universitetssjukhus Lund Sweden
Karolinska University Hospital Solna Sweden
Region Skane Kristianstad Central Hospital Kristianstad Sweden
Region Joenkoepings Laen Jönköping Sweden
Soedersjukhuset AB Stockholm Sweden
Ulcciul Uemcjvetfi Hosenqin Uppsala Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Not recruiting
03.05.2019

Trial locations

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.

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 ID:
2024-513430-37-00
Protocol code:
FACE-01
NCT ID:
NCT03781700
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of MK-1084 plus durvalumab versus placebo plus durvalumab in patients with locally advanced KRAS G12C‑mutated non‑small cell lung cancer after chemoradiotherapy

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Italy The Netherlands Poland
  • Venetoclax added to drug combination improves survival in children with relapsed acute myeloid leukemia

    Recruiting

    3 1 1 1
    Austria Belgium Czechia Denmark Finland France +8