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Scandinavian Bell's Palsy Study (SBPS)

This study has been completed.
Information provided by:
Uppsala University Hospital Identifier:
First received: July 30, 2007
Last updated: June 3, 2008
Last verified: June 2008
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.

Condition Intervention Phase
Bell's Palsy
Drug: Prednisolone + placebo
Drug: Valaciclovir + placebo
Drug: Prednisolone + valaciclovir
Drug: Placebo + placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre Placebo-Controlled Evaluation of Prednisolone and/or Valaciclovir for the Treatment of Bell's Palsy

Resource links provided by NLM:

Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • The primary endpoint will be the time to complete clinical recovery from Bell's palsy. [ Time Frame: 1, 2, 3, 6 or 12 months. ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 839
Study Start Date: May 2001
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00510263

Sponsors and Collaborators
Uppsala University Hospital
Principal Investigator: Mats Engstrom, M.D., Ph.D. Uppsala University, Sweden
Study Director: Lars Jonsson, M.D., Ph.D. Uppsala University, Sweden
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mats Engström, Uppsala University Identifier: NCT00510263     History of Changes
Other Study ID Numbers: 151:1828/99
Study First Received: July 30, 2007
Last Updated: June 3, 2008

Keywords provided by Uppsala University Hospital:

Additional relevant MeSH terms:
Bell Palsy
Facial Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal processed this record on May 22, 2017