Bell PalsyPhase 4NCT04406376
Do We Need to Taper Down Steroid Therapy for Bell's Palsy
A Phase 4 study testing Prednisone tablet in people with Bell Palsy, run by Carmel Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Prednisone tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteIsrael
- Study dates
- 12 May 2020to 1 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Lady Davies Carmel Medical Center. Department of Otolaryngology, Head and Neck Surgery
Haifa, North, 3436212
Itai Margulis, MD, +97248250279, itayma@clalit.org.il
Yoav Yanir, MD, +97248250433, yoavya@clalit.org.il
About this study
Official title: Do We Need to Taper Down Steroid Therapy for Bell's Palsy: A Prospective Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
A prospective randomized controlled trial of adult patients diagnosed with BP in the otolaryngology emergency department within 72 hours of symptoms onset.
Patients will be randomized to receive one of the following steroids regimens:
- Prednisone 1 mg/kg (max. 60 mg) daily for 7 days, 40 mg for 2 days, 20 mg for 2 days (Total 11 days)
- Prednisone 1 mg/kg (max. 60 mg) daily for 7 days (Total 7 days)
In addition, both groups will receive the following treatment when indicated:
- Mosturizing eye drops for 14 days or until complete recovery (HB-1)
- Mosturizing eye gel for 14 days or until complete recovery (HB-1)
- Omepradex once daily during prednisone treatment (unless the patient receives chronic treatment with any proton pump inhibitor).
- Acyclovir for 7 days in cases of severe BP (HB 5-6).
Patients' follow-up visits: 14 days, 1 month, 3 months. If recovery will be completed before 1 month, no more follow up visits will be taken.
In addition, side effects of prednisone use will be assessed as well as compliance to therapy and duration of additional symptoms.
- Conditions
- Bell Palsy
- Being tested
- Prednisone tablet
- Keywords
- Tapering Down, Adverse Effects, House Brackmann, Steroids, Prednisone
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone tabletDrug
Treatment of Bell's Palsy with prednisone, with or without tapering down.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Prednisone tablet |
| No Tapering Down of Steroids | Active comparator | Prednisone 1 mg/kg (max. 60 mg) daily for 7 days (Total 7 days) Receives: Drug: Prednisone tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 days- 90 days
Secondary outcomes (5)
Time to incomplete recovery
Time to presentation of House-Brackmann Grade II or worse and the difference between House-Brackmann scores between visits (i.e improvement from House-Brackmann 4 to 2)
Measured: 14 days- 90 days
Occurrence of Motor Synkinesis
Occurrence of abnormal synchronization of facial movement where muscles, other than those intended, contract together during a particular movement pattern.
Measured: 14 days- 90 days
Duration of neurological symptoms
Duration of hypoesthesia (trigeminal/ glossopharyngeal), periauricular pain, dysgusia, hyperacusis
Measured: 14 days- 90 days
Duration of ocular symptoms
Duration of dryness, epiphora, itching, eye pain, etc
Measured: 14 days- 90 days
Adverse effects of prednisone use
Incidence of dyspepsia, loss of blood sugar control, headache, fatigue, dizziness and insomnia, recurrent duodenal ulcers, mood swings, acute psychosis, etc
Measured: 14 days- 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start12 May 2020
- Primary completion1 May 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Itai Margulis, Carmel Medical Center
- Investigators
- Yoav Yanir, MD, Study director, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406376
- Sponsor's protocol ID
- CMC-20-0001-CTIL
- Status last verified
- Jul 2020
- First submitted
- 9 May 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do We Need to Taper Down Steroid Therapy for Bell's Palsy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04406376
- Acronym / sponsor ID
- CMC-20-0001-CTIL
- Conditions
- Bell Palsy
- Keywords
- Tapering Down, Adverse Effects, House Brackmann, Steroids, Prednisone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective randomized controlled trial of adult patients diagnosed with BP in the otolaryngology emergency department within 72 hours of symptoms onset.
Patients will be randomized to receive one of the following steroids regimens:
- Prednisone 1 mg/kg (max. 60 mg) daily for 7 days, 40 mg for 2 days, 20 mg for 2 days (Total 11 days)
- Prednisone 1 mg/kg (max. 60 mg) daily for 7 days (Total 7 days)
In addition, both groups will receive the following treatment when indicated:
- Mosturizing eye drops for 14 days or until complete recovery (HB-1)
- Mosturizing eye gel for 14 days or until complete recovery (HB-1)
- Omepradex once daily during prednisone treatment (unless the patient receives chronic treatment with any proton pump inhibitor).
- Acyclovir for 7 days in cases of severe BP (HB 5-6).
Patients' follow-up visits: 14 days, 1 month, 3 months. If recovery will be completed before 1 month, no more follow up visits will be taken.
In addition, side effects of prednisone use will be assessed as well as compliance to therapy and duration of additional symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Tapering Down of Steroids | Active comparator | Drug: Prednisone tabletPrednisone 1 mg/kg (max. 60 mg) daily for 7 days, 40 mg for 2 days, 20 mg for 2 days (Total 11 days) |
| No Tapering Down of Steroids | Active comparator | Drug: Prednisone tabletPrednisone 1 mg/kg (max. 60 mg) daily for 7 days (Total 7 days) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone tabletTreatment of Bell's Palsy with prednisone, with or without tapering down. | Drug | No Tapering Down of Steroids, Tapering Down of Steroids |
Primary outcome
House-Brackmann scale
Time frame: 14 days- 90 days
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).
5 secondary outcomes
Time to incomplete recovery
Time frame: 14 days- 90 days
Occurrence of Motor Synkinesis
Time frame: 14 days- 90 days
Duration of neurological symptoms
Time frame: 14 days- 90 days
Duration of ocular symptoms
Time frame: 14 days- 90 days
Adverse effects of prednisone use
Time frame: 14 days- 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoav Yanir, MD study director
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone tablet in people with Bell Palsy, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Itai Margulis, MD (972-48250279, itayma@clalit.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
House-Brackmann scale (time frame: 14 days- 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.