Bell's PalsyPhase 4SBPSNCT00510263
Scandinavian Bell's Palsy Study
A Phase 4 study testing Prednisolone + valaciclovir in people with Bell's Palsy, run by Uppsala University Hospital.
Trial summary
The main objective of this study is to study the effects of prednisolone and valaciclovir, with equal importance, compared to placebo for the treatment of Bell´s palsy. The combination of prednisolone and valaciclovir will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bell's Palsy
- What is being tested?
- Prednisolone + valaciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 839 participants
- Where
- No sites listed yet
- Study dates
- May 2001to Sep 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be in good general health and between 18 and 75 years of age.
- Have an acute peripheral unilateral idiopathic facial palsy.
- Not more than 72 hours must have passed after onset of palsy before initiating study medication.
- The subjects must provide their freely given written informed consent.
Who cannot join
- Subjects who have used any antiherpetic medication, except locally applied formulations, within the last 2 weeks.
- Subjects with ongoing systemic steroid medication for another disease.
- Pregnant women or nursing mothers.
- Subjects with diabetes.
- Subjects presently suffering from gastric or duodenal ulcers. If there is a history of previous peptic ulcers or dyspepsia prophylactic medication must be prescribed and taken during study.
- Subjects with a history of tuberculosis.
Show all 18Show fewer
- Subjects with psychiatric diagnosis that are at risk to be influenced by the study drugs or that might affect the patient´s ability to complete this study.
- Subjects with a hypertension not well controlled.
- Subjects with a present, or a history of, serious heart disease.
- Subjects with a history of glaucoma.
- Subjects with a history of hepatic disease.
- Subjects with other neurological diseases.
- Subjects with a history of renal diseases or a known creatinine clearance of < 30mL/min.
- Subjects with acute otitis or a history of ipsilateral chronic otitis.
- Subjects with a history of recent head injury.
- Fertile, sexually active women not employing acceptable methods of contraception and/or women planning to become pregnant during the period with intake of study medication.
- Subjects with a history of immunodeficiency syndromes.
- Subjects with an allergy or sensitivity to aciclovir or valaciclovir, famciclovir or ganciclovir.
About this study
Official title: A Multicentre Placebo-Controlled Evaluation of Prednisolone and/or Valaciclovir for the Treatment of Bell's Palsy
The main objective of this study is to study the effects of prednisolone and valaciclovir, with equal importance, compared to placebo for the treatment of Bell´s palsy. The combination of prednisolone and valaciclovir will also be studied.
Read the detailed description
Study Design:
This is a multicentre randomised double-blind placebo-controlled study.
Study medication:
Prednisolone 60 mg per day for 5 days, after that tapering 10 mg per day for a total treatment time of 10 days. Valaciclovir 1000 mg 3 times per day for 7 days. Prednisolone and valaciclovir are used in combination or separately. One patient of four receives placebo.
Study Duration:
Study medication will be taken during 10 days. The subjects will be followed for 12 months after initiation of treatment. Follow-up visits will be 11-15 days after start of therapy and at 1, 2, 3, 6 and 12 months after the onset of palsy.
Study Setting:
The study will be conducted in 17 ENT-clinics in Sweden and Finland, which will be monitored by the members of the board of the Scandinavian Bells Palsy Study (SBPS)
Study Subjects:
Otherwise healthy subjects with unilateral acute idiopathic facial palsy. A total of 800 subjects will be included in the study.
Study Treatments:
The subjects will be randomised to one of the following treatment arms for oral administration of study drug:
- Prednisolone + placebo
- Valaciclovir + placebo
- Prednisolone + valaciclovir
- Placebo + placebo
Treatment will be initiated within 72 hours of onset of palsy and continued during 10 days.
Measurements:
The first follow-up clinical examination is scheduled within 3 days after completed treatment. Further follow-up visits are scheduled at 1, 2, 3 and 6 months from onset of palsy. If complete recovery has occurred at the 2 month visit, the 3 and 6 months visits are not necessary. If complete recovery is present at 3 months the 6 month visit can be excluded. A final follow-up exam is always performed at 12 months. The clinical examination includes a routine examination of ear, nose and throat, grading of the palsy according to the Sunnybrook and House Brackmann grading scales and registration of other symptoms as pain, eye irritation, dysacusis and impaired taste. Blood tests for Lyme Borreliosis are drawn at the acute (the first) visit and at the follow-up visit at 2 months.
Primary Endpoint:
The primary endpoint will be the time to complete clinical recovery (defined as 100 on the Sunnybrook facial nerve grading scale) from Bell's palsy. The subjects will be categorised as healed or not healed at months 1, 2, 3, 6 or 12 months. Treatments will be compared using the Generalized Wilcoxon rank sum test. Patients where data are missing and there is no healing time will be included as censored at the last visit when the patient was not healed.
Secondary endpoints:
The secondary endpoints of this study are comparisons between the different treatment arms with regard to:
- Proportion of patients with complete healing of palsy compared to those with incomplete healing at12 months after onset.
- Influence on outcome at 12 months by time in hours from onset of palsy until beginning of study medication.
- Proportion of patients that develop severe palsy during the first week from onset.
- The total duration of pain, in or around the ipsilateral ear or the ipsilateral side of the face, from onset of palsy.
- The proportion of subjects with severe pain (more than VAS 3) in the different treatment arms.
- Occurrence of synkinesia in the different treatment arms at any time.
- Occurrence of facial spasm or contracture in the different treatment arms at any time.
- Severity of remaining facial symptoms in patients not healed at 12 months and at each prescheduled study visit as recorded by Sunnybrook Facial Grading System.
Safety Evaluations:
Adverse events will be assessed during the first study month. Adverse events will be reported in the patient's files and in the patient CRF for this study.
- Conditions
- Bell's Palsy
- Being tested
- Prednisolone + placebo, Valaciclovir + placebo, Prednisolone + valaciclovir, Placebo + placebo
- Keywords
- Prednisolone, Valacyclovir
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone + placeboDrug
Prednisolone 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Placebo 2 tablets 3 times daily for 7 days.
Valaciclovir + placeboDrug
Valaciclovir 500 mg 2 tablets 3 times daily for 7 days. Placebo tablets 12 per day for 5 days, tapering 2 tablets per day until day 10.
Prednisolone + valaciclovirDrug
Prednisolone 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Valaciclovir 500 mg 2 tablets 3 times daily for 7 days.
Placebo + placeboDrug
Placebo 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Placebo 2 tablets 3 times daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Prednisolone + placebo |
| 2 | Experimental | Not described Receives: Drug: Valaciclovir + placebo |
| 3 | Experimental | Not described Receives: Drug: Prednisolone + valaciclovir |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the time to complete clinical recovery from Bell's palsy.
Measured: 1, 2, 3, 6 or 12 months.
Secondary outcomes (8)
Proportion of patients with complete healing of palsy compared to those with incomplete healing at 12 months after onset.
Measured: 12 months
Influence on outcome at 12 months by time in hours from onset of palsy until beginning of study medication.
Measured: 12 months
Proportion of patients that develop severe palsy during the first week from onset.
Measured: One week
The total duration of pain, in or around the ipsilateral ear or the ipsilateral side of the face, from onset of palsy.
Measured: Two months
The proportion of subjects with severe pain (more than VAS 3) in the different treatment arms.
Measured: Two months
Occurrence of synkinesia in the different treatment arms at any time.
Measured: 12 months
Occurrence of facial spasm or contracture in the different treatment arms at any time.
Measured: 12 months
Severity of remaining facial symptoms in patients not healed at 12 months and at each prescheduled study visit.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startMay 2001
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bell's 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 839 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Pfizer
- Investigators
- Mats Engstrom, M.D., Ph.D., Principal investigator, Uppsala University, SwedenLars Jonsson, M.D., Ph.D., Study director, Uppsala University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510263
- Sponsor's protocol ID
- 151:1828/99
- Acronym
- SBPS
- Status last verified
- Jun 2008
- First submitted
- 30 Jul 2007
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berg T, Bylund N, Marsk E, Jonsson L, Kanerva M, Hultcrantz M, Engstrom M. The effect of prednisolone on sequelae in Bell's palsy. Arch Otolaryngol Head Neck Surg. 2012 May;138(5):445-9. doi: 10.1001/archoto.2012.513.
PubMed 22652942Engstrom M, Berg T, Stjernquist-Desatnik A, Axelsson S, Pitkaranta A, Hultcrantz M, Kanerva M, Hanner P, Jonsson L. Prednisolone and valaciclovir in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet Neurol. 2008 Nov;7(11):993-1000. doi: 10.1016/S1474-4422(08)70221-7. Epub 2008 Oct 10.
PubMed 18849193
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Placebo-Controlled Evaluation of Prednisolone and/or Valaciclovir for the Treatment of Bell's Palsy
- ClinicalTrials.gov ID
- NCT00510263
- Acronym / sponsor ID
- SBPS / 151:1828/99
- Conditions
- Bell's Palsy
- Keywords
- Prednisolone, Valacyclovir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 839 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Pfizer
- Study start
- May 2001
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 1 Aug 2007 (estimated)
- 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.
The main objective of this study is to study the effects of prednisolone and valaciclovir, with equal importance, compared to placebo for the treatment of Bell´s palsy. The combination of prednisolone and valaciclovir will also be studied.
Detailed description
Study Design:
This is a multicentre randomised double-blind placebo-controlled study.
Study medication:
Prednisolone 60 mg per day for 5 days, after that tapering 10 mg per day for a total treatment time of 10 days. Valaciclovir 1000 mg 3 times per day for 7 days. Prednisolone and valaciclovir are used in combination or separately. One patient of four receives placebo.
Study Duration:
Study medication will be taken during 10 days. The subjects will be followed for 12 months after initiation of treatment. Follow-up visits will be 11-15 days after start of therapy and at 1, 2, 3, 6 and 12 months after the onset of palsy.
Study Setting:
The study will be conducted in 17 ENT-clinics in Sweden and Finland, which will be monitored by the members of the board of the Scandinavian Bells Palsy Study (SBPS)
Study Subjects:
Otherwise healthy subjects with unilateral acute idiopathic facial palsy. A total of 800 subjects will be included in the study.
Study Treatments:
The subjects will be randomised to one of the following treatment arms for oral administration of study drug:
- Prednisolone + placebo
- Valaciclovir + placebo
- Prednisolone + valaciclovir
- Placebo + placebo
Treatment will be initiated within 72 hours of onset of palsy and continued during 10 days.
Measurements:
The first follow-up clinical examination is scheduled within 3 days after completed treatment. Further follow-up visits are scheduled at 1, 2, 3 and 6 months from onset of palsy. If complete recovery has occurred at the 2 month visit, the 3 and 6 months visits are not necessary. If complete recovery is present at 3 months the 6 month visit can be excluded. A final follow-up exam is always performed at 12 months. The clinical examination includes a routine examination of ear, nose and throat, grading of the palsy according to the Sunnybrook and House Brackmann grading scales and registration of other symptoms as pain, eye irritation, dysacusis and impaired taste. Blood tests for Lyme Borreliosis are drawn at the acute (the first) visit and at the follow-up visit at 2 months.
Primary Endpoint:
The primary endpoint will be the time to complete clinical recovery (defined as 100 on the Sunnybrook facial nerve grading scale) from Bell's palsy. The subjects will be categorised as healed or not healed at months 1, 2, 3, 6 or 12 months. Treatments will be compared using the Generalized Wilcoxon rank sum test. Patients where data are missing and there is no healing time will be included as censored at the last visit when the patient was not healed.
Secondary endpoints:
The secondary endpoints of this study are comparisons between the different treatment arms with regard to:
- Proportion of patients with complete healing of palsy compared to those with incomplete healing at12 months after onset.
- Influence on outcome at 12 months by time in hours from onset of palsy until beginning of study medication.
- Proportion of patients that develop severe palsy during the first week from onset.
- The total duration of pain, in or around the ipsilateral ear or the ipsilateral side of the face, from onset of palsy.
- The proportion of subjects with severe pain (more than VAS 3) in the different treatment arms.
- Occurrence of synkinesia in the different treatment arms at any time.
- Occurrence of facial spasm or contracture in the different treatment arms at any time.
- Severity of remaining facial symptoms in patients not healed at 12 months and at each prescheduled study visit as recorded by Sunnybrook Facial Grading System.
Safety Evaluations:
Adverse events will be assessed during the first study month. Adverse events will be reported in the patient's files and in the patient CRF for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Prednisolone + placebo |
| 2 | Experimental | Drug: Valaciclovir + placebo |
| 3 | Experimental | Drug: Prednisolone + valaciclovir |
| 4 | Placebo comparator | Drug: Placebo + placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be in good general health and between 18 and 75 years of age.
- Have an acute peripheral unilateral idiopathic facial palsy.
- Not more than 72 hours must have passed after onset of palsy before initiating study medication.
- The subjects must provide their freely given written informed consent.
Key exclusion criteria (18 listed)
- Subjects who have used any antiherpetic medication, except locally applied formulations, within the last 2 weeks.
- Subjects with ongoing systemic steroid medication for another disease.
- Pregnant women or nursing mothers.
- Subjects with diabetes.
- Subjects presently suffering from gastric or duodenal ulcers. If there is a history of previous peptic ulcers or dyspepsia prophylactic medication must be prescribed and taken during study.
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 |
|---|---|---|
| Prednisolone + placeboPrednisolone 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Placebo 2 tablets 3 times daily for 7 days. | Drug | 1 |
| Valaciclovir + placeboValaciclovir 500 mg 2 tablets 3 times daily for 7 days. Placebo tablets 12 per day for 5 days, tapering 2 tablets per day until day 10. | Drug | 2 |
| Prednisolone + valaciclovirPrednisolone 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Valaciclovir 500 mg 2 tablets 3 times daily for 7 days. | Drug | 3 |
| Placebo + placeboPlacebo 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Placebo 2 tablets 3 times daily for 7 days. | Drug | 4 |
Primary outcome
The primary endpoint will be the time to complete clinical recovery from Bell's palsy.
Time frame: 1, 2, 3, 6 or 12 months.
8 secondary outcomes
Proportion of patients with complete healing of palsy compared to those with incomplete healing at 12 months after onset.
Time frame: 12 months
Influence on outcome at 12 months by time in hours from onset of palsy until beginning of study medication.
Time frame: 12 months
Proportion of patients that develop severe palsy during the first week from onset.
Time frame: One week
The total duration of pain, in or around the ipsilateral ear or the ipsilateral side of the face, from onset of palsy.
Time frame: Two months
The proportion of subjects with severe pain (more than VAS 3) in the different treatment arms.
Time frame: Two months
Occurrence of synkinesia in the different treatment arms at any time.
Time frame: 12 months
Occurrence of facial spasm or contracture in the different treatment arms at any time.
Time frame: 12 months
Severity of remaining facial symptoms in patients not healed at 12 months and at each prescheduled study visit.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
- Derived from this study: PubMed 22652942Berg T, Bylund N, Marsk E, Jonsson L, Kanerva M, Hultcrantz M, Engstrom M. The effect of prednisolone on sequelae in Bell's palsy. Arch Otolaryngol Head Neck Surg. 2012 May;138(5):445-9. doi: 10.1001/archoto.2012.513.
- Derived from this study: PubMed 18849193Engstrom M, Berg T, Stjernquist-Desatnik A, Axelsson S, Pitkaranta A, Hultcrantz M, Kanerva M, Hanner P, Jonsson L. Prednisolone and valaciclovir in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet Neurol. 2008 Nov;7(11):993-1000. doi: 10.1016/S1474-4422(08)70221-7. Epub 2008 Oct 10.
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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.
Mats Engstrom, M.D., Ph.D. principal investigator
Uppsala University, Sweden
Lars Jonsson, M.D., Ph.D. study director
Uppsala University, Sweden
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone + valaciclovir in people with Bell's Palsy, run by Uppsala University Hospital.
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 4 inclusion and 18 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: finished, as of the sponsor's last update on 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be the time to complete clinical recovery from Bell's palsy. (time frame: 1, 2, 3, 6 or 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00510263, which also lists 2 linked publications.
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 4 Jun 2008; AzTrials last refreshed its copy on 28 Oct 2026.