Scandinavian Bell's Palsy Study (SBPS)
Primary Purpose
Bell's Palsy
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Prednisolone + placebo
Valaciclovir + placebo
Prednisolone + valaciclovir
Placebo + placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bell's Palsy focused on measuring Prednisolone, Valacyclovir
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
The primary endpoint will be the time to complete clinical recovery from Bell's palsy.
Secondary Outcome Measures
Proportion of patients with complete healing of palsy compared to those with incomplete healing at 12 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.
Full Information
NCT ID
NCT00510263
First Posted
July 30, 2007
Last Updated
June 3, 2008
Sponsor
Uppsala University Hospital
Collaborators
GlaxoSmithKline, Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00510263
Brief Title
Scandinavian Bell's Palsy Study
Acronym
SBPS
Official Title
A Multicentre Placebo-Controlled Evaluation of Prednisolone and/or Valaciclovir for the Treatment of Bell's Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Uppsala University Hospital
Collaborators
GlaxoSmithKline, Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell's Palsy
Keywords
Prednisolone, Valacyclovir
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
839 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Prednisolone + placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Valaciclovir + placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone + valaciclovir
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo + placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint will be the time to complete clinical recovery from Bell's palsy.
Time Frame
1, 2, 3, 6 or 12 months.
Secondary Outcome Measure Information:
Title
Proportion of patients with complete healing of palsy compared to those with incomplete healing at 12 months after onset.
Time Frame
12 months
Title
Influence on outcome at 12 months by time in hours from onset of palsy until beginning of study medication.
Time Frame
12 months
Title
Proportion of patients that develop severe palsy during the first week from onset.
Time Frame
One week
Title
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
Title
The proportion of subjects with severe pain (more than VAS 3) in the different treatment arms.
Time Frame
Two months
Title
Occurrence of synkinesia in the different treatment arms at any time.
Time Frame
12 months
Title
Occurrence of facial spasm or contracture in the different treatment arms at any time.
Time Frame
12 months
Title
Severity of remaining facial symptoms in patients not healed at 12 months and at each prescheduled study visit.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats Engstrom, M.D., Ph.D.
Organizational Affiliation
Uppsala University, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Jonsson, M.D., Ph.D.
Organizational Affiliation
Uppsala University, Sweden
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
22652942
Citation
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.
Results Reference
derived
PubMed Identifier
18849193
Citation
Engstrom 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.
Results Reference
derived
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Scandinavian Bell's Palsy Study
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