Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510263
Status:
COMPLETED
Last Update Posted:
2008-06-04
First Post:
2007-07-30
Brief Title:
Scandinavian Bells Palsy Study
Sponsor:
Uppsala University Hospital
Organization:
Uppsala University Hospital
Study Overview
Official Title:
A Multicentre Placebo-Controlled Evaluation of Prednisolone andor Valaciclovir for the Treatment of Bells Palsy
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SBPS
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 Bells 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 Bells 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 patients files and in the patient CRF for this study
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 Bells 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 patients files and in the patient CRF for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None