Scandinavian Bell's Palsy Study

NCT00510263 | Completed Phase 4 DMC

• 1 other identifier: 151:1828/99
• Study Type: interventional
• Target: 839
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bell's Palsy

Keywords

Prednisolone; Valacyclovir

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be the time to complete clinical recovery from Bell's palsy.

  1, 2, 3, 6 or 12 months.

Secondary Outcomes (8)

• Proportion of patients with complete healing of palsy compared to those with incomplete healing at 12 months after onset.

  12 months

• Influence on outcome at 12 months by time in hours from onset of palsy until beginning of study medication.

  12 months

• Proportion of patients that develop severe palsy during the first week from onset.

  One week

• The total duration of pain, in or around the ipsilateral ear or the ipsilateral side of the face, from onset of palsy.

  Two months

• The proportion of subjects with severe pain (more than VAS 3) in the different treatment arms.

  Two months

Study Arms (4)

1

EXPERIMENTAL

Drug: Prednisolone + placebo

2

EXPERIMENTAL

Drug: Valaciclovir + placebo

3

EXPERIMENTAL

Drug: Prednisolone + valaciclovir

4

PLACEBO COMPARATOR

Drug: Placebo + placebo

Interventions

Prednisolone + placebo DRUG

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.

1

Valaciclovir + placebo DRUG

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.

2

Prednisolone + valaciclovir DRUG

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.

3

Placebo + placebo DRUG

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.

4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be in good general health and between 18 and 75 years of age.
• Have an acute peripheral unilateral idiopathic facial palsy.
• Not more than 72 hours must have passed after onset of palsy before initiating study medication.
• The subjects must provide their freely given written informed consent.

You may not qualify if:

• Subjects who have used any antiherpetic medication, except locally applied formulations, within the last 2 weeks.
• Subjects with ongoing systemic steroid medication for another disease.
• Pregnant women or nursing mothers.
• Subjects with diabetes.
• 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.
• Subjects with a history of tuberculosis.
• 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.
• Subjects with a hypertension not well controlled.
• Subjects with a present, or a history of, serious heart disease.
• Subjects with a history of glaucoma.
• Subjects with a history of hepatic disease.
• Subjects with other neurological diseases.
• Subjects with a history of renal diseases or a known creatinine clearance of \< 30mL/min.
• Subjects with acute otitis or a history of ipsilateral chronic otitis.
• Subjects with a history of recent head injury.

Sponsors & Collaborators

• Uppsala University Hospital: lead
• GlaxoSmithKline: collaborator
• Pfizer: collaborator

Related Publications (2)

• Berg T, Bylund N, Marsk E, Jonsson L, Kanerva M, Hultcrantz M, Engstrom M. The effect of prednisolone on sequelae in Bell's palsy. Arch Otolaryngol Head Neck Surg. 2012 May;138(5):445-9. doi: 10.1001/archoto.2012.513.

  PMID: 22652942 DERIVED

• Engstrom M, Berg T, Stjernquist-Desatnik A, Axelsson S, Pitkaranta A, Hultcrantz M, Kanerva M, Hanner P, Jonsson L. Prednisolone and valaciclovir in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet Neurol. 2008 Nov;7(11):993-1000. doi: 10.1016/S1474-4422(08)70221-7. Epub 2008 Oct 10.

  PMID: 18849193 DERIVED

MeSH Terms

Conditions

Bell Palsy

Interventions

Prednisolone; Valacyclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mats Engstrom, M.D., Ph.D.

  Uppsala University, Sweden

  PRINCIPAL INVESTIGATOR

• Lars Jonsson, M.D., Ph.D.

  Uppsala University, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 30, 2007
• First Posted: August 1, 2007
• Study Start: May 1, 2001
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 4, 2008

Record last verified: 2008-06