Scandinavian Bell's Palsy Study - Full Text View

Sponsor:	Uppsala University Hospital
Collaborators:	GlaxoSmithKline Pfizer
Information provided by:	Uppsala University Hospital
ClinicalTrials.gov Identifier:	NCT00510263

Purpose

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Bell's Palsy Paralysis

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone Sodium Phosphate Prednisolone phosphate Methylprednisolone Sodium Succinate Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

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. ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
Influence on outcome at 12 months by time in hours from onset of palsy until beginning of study medication. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Proportion of patients that develop severe palsy during the first week from onset. [ Time Frame: One week ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
The proportion of subjects with severe pain (more than VAS 3) in the different treatment arms. [ Time Frame: Two months ] [ Designated as safety issue: No ]
Occurrence of synkinesia in the different treatment arms at any time. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Occurrence of facial spasm or contracture in the different treatment arms at any time. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Severity of remaining facial symptoms in patients not healed at 12 months and at each prescheduled study visit. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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.

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Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.
Subjects with a history of immunodeficiency syndromes.
Subjects with an allergy or sensitivity to aciclovir or valaciclovir, famciclovir or ganciclovir.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510263

Sponsors and Collaborators

Uppsala University Hospital

GlaxoSmithKline

Pfizer

Investigators

Principal Investigator:	Mats Engstrom, M.D., Ph.D.	Uppsala University, Sweden
Study Director:	Lars Jonsson, M.D., Ph.D.	Uppsala University, Sweden

More Information

No publications provided by Uppsala University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Engström M, Berg T, Stjernquist-Desatnik A, Axelsson S, Pitkäranta 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. Epub 2008 Oct 10.

Responsible Party:	Mats Engström, Uppsala University
ClinicalTrials.gov Identifier:	NCT00510263 History of Changes
Other Study ID Numbers:	151:1828/99
Study First Received:	July 30, 2007
Last Updated:	June 3, 2008
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Uppsala University Hospital:

Prednisolone
Valacyclovir

Additional relevant MeSH terms:

Bell Palsy
Facial Paralysis
Paralysis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Methylprednisolone acetate
Prednisolone acetate

Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone phosphate
Valacyclovir
Acyclovir
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 22, 2012