Do We Need to Taper Down Steroid Therapy for Bell's Palsy

NCT04406376 | Unknown Phase 4 DMC

• 1 other identifier: CMC-20-0001-CTIL
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Bell's palsy \[BP\] is defined as acute idiopathic peripheral facial palsy or paralysis. Additional symptoms frequently include pain around or behind the ear, impaired tolerance to ordinary levels of noise and disturbed sense of taste on the same side. It affects men and women more or less equally. There is a consensus in the literature regarding the importance of steroid treatment for improving recovery rates and sequela of BP. Moreover, there is increasing level of high quality of evidence in recent years for a combined antiviral and steroids treatment for severe BP (House Brackmann \[HB\] 5-6). Adverse effects (AEs) were reported in 1-12% of patients treated with steroids, antivirals or placebo. The AEs reported were dyspepsia, loss of blood sugar control, headache, fatigue, dizziness and insomnia, recurrent duodenal ulcers, mood swings, and acute psychosis. All effects resolved when treatment was stopped. Although steroid and antivirals are widely used for BP, there is a high variability of steroids treatment, both in the dosage given and in the way of tapering down. Among the different steroid regimens used were: prednisone 1 mg/kg for 5 days tapered to 10 mg/day for remaining 5 days; prednisone (1 mg/kg for 10 days then tapered to zero over the next 6 days); prednisolone 60 mg for 5 days, 30 mg for 3 days, and 10 mg for 2 days. House-Brackmann (HB) system is widely used for facial function assessment. It is based on a six-grade score, where grade I is normal function, grade VI is complete absence of facial motor function, and grades II to V are intermediate. Steroid-induced side effects generally require tapering of the drug as soon as the disease being treated is under control. Tapering must be done carefully to avoid both recurrent activity of the underlying disease and possible cortisol deficiency resulting from hypothalamic-pituitary-adrenal axis (HPA) suppression. However, according to a review by Furst et al (2019), a patient who has received any dose of glucocorticoid for less than 3 weeks or patients treated with alternate-day prednisone at a dose of less than 10 mg (or its equivalent) are unlikely for HPA suppression. They concluded that short-term glucocorticoid therapy (up to three weeks), even if at a fairly high dose, can simply be stopped and need not to be tapered.. According to the above, the investigators assume that a rapid withdrawal of steroids after short course of treatment for BP should neither influence the efficacy or safety of treatment. Finally, steroid regimen may be hard to follow for some patients and can results in confusion and frustration. Simplifying steroid regimen, such as skipping withdrawal if not necessary, may solve this problem. The objective of our study is to determine the effectiveness and safety of prednisone treatment with no tapering down for Bell's Palsy.

Conditions

Bell Palsy

Keywords

Tapering Down; Adverse Effects; House Brackmann; Steroids; Prednisone

Outcome Measures

Primary Outcomes (1)

• House-Brackmann scale

  Time to complete recovery (Grade I- normal function) of facial palsy using the House-Brackmann scale for assessment. The scale is assessed by an ENT physician in four standard poses: at rest, with a forced smile, with raised eyebrows, and with eyes tightly closed and scored between I (normal function)- VI (complete palsy, worse outcome).

  14 days- 90 days

Secondary Outcomes (5)

• Time to incomplete recovery

  14 days- 90 days

• Occurrence of Motor Synkinesis

  14 days- 90 days

• Duration of neurological symptoms

  14 days- 90 days

• Duration of ocular symptoms

  14 days- 90 days

• Adverse effects of prednisone use

  14 days- 90 days

Study Arms (2)

Tapering Down of Steroids

ACTIVE COMPARATOR

Prednisone 1 mg/kg (max. 60 mg) daily for 7 days, 40 mg for 2 days, 20 mg for 2 days (Total 11 days)

Drug: Prednisone tablet

No Tapering Down of Steroids

ACTIVE COMPARATOR

Prednisone 1 mg/kg (max. 60 mg) daily for 7 days (Total 7 days)

Drug: Prednisone tablet

Interventions

Prednisone tablet DRUG

Treatment of Bell's Palsy with prednisone, with or without tapering down.

No Tapering Down of Steroids; Tapering Down of Steroids

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years) diagnosed with BP within 72 hour of onset.
• Adult patients willing to get treatment, attending follow up visits and signing informed consent.

You may not qualify if:

• Patients treated with antivirals (i.e acyclovir) for any reason simultaneously, such as Herpes Zoster (Ramsay- Hunt syndrome).
• Palsy onset \> 72 hours before diagnosis or unknown onset.
• Previous episodes of BP.
• Patients suspected for hypothalamic-pituitary-adrenal (HPA) axis suppression who have to be cautiously tapered due to high risk for adrenal insufficiency: steroid treatment in any dosage for more the 3 weeks (due to other indication) or cushingoid appearance.
• Contraindication for steroid use: uncontrolled diabetes or hypertension, psychosis, peptic ulcer or upper GI bleeding, liver cirrhosis or portal hypertension, known allergy to prednisone, etc. Any case in which steroid treatment was stopped earlier than planned by the patient or the physician.
• Any conditions suspicious for non-idiopathic facial palsy: chronic otitis media, acute otitis media, mastoiditis, temporal bone/middle ear trauma, other cranial nerve neuropathies (i.e cranial nerve VIII), cerebrovascular disorders, tumor affecting facial nerve (i.e, parotid malignancy, schwannoma) or systemic causes (i.e multiple sclerosis, meningitis, sarcoidosis, HIV infection, etc).
• Patients with low compliance for treatment according to the physician.
• Pregnancy or breast-feeding patients.

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Lady Davies Carmel Medical Center. Department of Otolaryngology, Head and Neck Surgery

Haifa, North, 3436212, Israel

RECRUITING

MeSH Terms

Conditions

Bell Palsy

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yoav Yanir, MD

  Carmel Medical Center

  STUDY DIRECTOR

Central Study Contacts

Itai Margulis, MD

CONTACT

972-48250279; itayma@clalit.gov.il

Raanan Cohen-Kerem, MD

CONTACT

972-48250005; raanan@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intern, Department of Otolaryngology Head and Neck Surgery, Principal Investigator, Medical Doctor

Model Details: Patients will be randomized to recieve one of the following steroids regimens: 1. Prednisone 1 mg/kg (max. 60 mg) daily for 7 days, 40 mg for 2 days, 20 mg for 2 days (Total 11 days) 2. Prednisone 1 mg/kg (max. 60 mg) daily for 7 days (Total 7 days)

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 28, 2020
• Study Start: May 12, 2020
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

IL (1)