ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
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.
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.
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Descriptive Information | |||||||
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Brief Title ICMJE | Scandinavian Bell's Palsy Study | ||||||
Official Title ICMJE | 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 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:
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:
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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | Bell's Palsy | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 839 | ||||||
Original Estimated Enrollment ICMJE | 800 | ||||||
Actual Study Completion Date ICMJE | September 2007 | ||||||
Actual Primary Completion Date | September 2007 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00510263 | ||||||
Other Study ID Numbers ICMJE | 151:1828/99 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Mats Engström, Uppsala University | ||||||
Study Sponsor ICMJE | Uppsala University Hospital | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Uppsala University Hospital | ||||||
Verification Date | June 2008 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |