NCT04406376

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

Status unknown Phase 4 Last updated 28 July 2020

What this trial tests

Phase 4 trial testing Prednisone tablet in Bell Palsy in 124 participants. Status unknown.

Timeline

12 May 2020

Primary endpoint
1 May 2023

1 August 2023

Quick facts

Lead sponsor	Carmel Medical Center
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	124
Start date	12 May 2020
Primary completion	1 May 2023
Estimated completion	1 August 2023
Sites	1 location across Israel

Drugs / interventions tested

• Prednisone tablet

Conditions studied

• Bell Palsy — all drugs for Bell Palsy →

Sponsor

Carmel Medical Center

Who can join

Adults 18 to 80, any sex, with Bell Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.