Scandinavian Bell's Palsy Study
Condition: Bell's Palsy
MeSH terms: Bell Palsy; Facial Paralysis
Study type: Interventional
Phase: Phase 4

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:

        1. Prednisolone + placebo

        2. Valaciclovir + placebo

        3. Prednisolone + valaciclovir

        4. 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.
    

Intervention name(s): Prednisolone + placebo; Valaciclovir + placebo; Prednisolone + valaciclovir; Placebo + placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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 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 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 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 MeSH terms: Valacyclovir; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prednisolone; Valacyclovir