Scandinavian Bell's Palsy Study (SBPS)

June 3, 2008 updated by: Uppsala University Hospital

A Multicentre Placebo-Controlled Evaluation of Prednisolone and/or Valaciclovir for the Treatment of Bell's Palsy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
839

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: Prednisolone + placebo
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.
Experimental: 2
Drug: Valaciclovir + placebo
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.
Experimental: 3
Drug: Prednisolone + valaciclovir
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 Comparator: 4
Drug: Placebo + placebo
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary endpoint will be the time to complete clinical recovery from Bell's palsy.
Time Frame: 1, 2, 3, 6 or 12 months.
1, 2, 3, 6 or 12 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of patients with complete healing of palsy compared to those with incomplete healing at 12 months after onset.
Time Frame: 12 months
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
12 months
Proportion of patients that develop severe palsy during the first week from onset.
Time Frame: One week
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
Two months
The proportion of subjects with severe pain (more than VAS 3) in the different treatment arms.
Time Frame: Two months
Two months
Occurrence of synkinesia in the different treatment arms at any time.
Time Frame: 12 months
12 months
Occurrence of facial spasm or contracture in the different treatment arms at any time.
Time Frame: 12 months
12 months
Severity of remaining facial symptoms in patients not healed at 12 months and at each prescheduled study visit.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mats Engstrom, M.D., Ph.D., Uppsala University, Sweden
  • Study Director: Lars Jonsson, M.D., Ph.D., Uppsala University, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 151:1828/99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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