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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
Uppsala University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell's Palsy focused on measuring Prednisolone, Valacyclovir

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be in good general health and between 18 and 75 years of age.
  2. Have an acute peripheral unilateral idiopathic facial palsy.
  3. Not more than 72 hours must have passed after onset of palsy before initiating study medication.
  4. The subjects must provide their freely given written informed consent.

Exclusion Criteria:

  1. Subjects who have used any antiherpetic medication, except locally applied formulations, within the last 2 weeks.
  2. Subjects with ongoing systemic steroid medication for another disease.
  3. Pregnant women or nursing mothers.
  4. Subjects with diabetes.
  5. 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.
  6. Subjects with a history of tuberculosis.
  7. 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.
  8. Subjects with a hypertension not well controlled.
  9. Subjects with a present, or a history of, serious heart disease.
  10. Subjects with a history of glaucoma.
  11. Subjects with a history of hepatic disease.
  12. Subjects with other neurological diseases.
  13. Subjects with a history of renal diseases or a known creatinine clearance of < 30mL/min.
  14. Subjects with acute otitis or a history of ipsilateral chronic otitis.
  15. Subjects with a history of recent head injury.
  16. 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.
  17. Subjects with a history of immunodeficiency syndromes.
  18. 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

    First Posted
    July 30, 2007
    Last Updated
    June 3, 2008
    Sponsor
    Uppsala University Hospital
    Collaborators
    GlaxoSmithKline, Pfizer
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    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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