Clinical Trial: Scandinavian Bell's Palsy Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicentre Placebo-Controlled Evaluation of Prednisolone and/or Valaciclovir for the Treatment of Bell's Palsy
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 Summary:
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
Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Uppsala University Hospital
Dates:
Date Received: July 30, 2007
Date Started: May 2001
Date Completion:
Last Updated: June 3, 2008
Last Verified: June 2008