Scandinavian Bell's Palsy Study

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uppsala University Hospital
• Collaborators: GlaxoSmithKline; Pfizer
• Treatments: Acyclovir; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Valacyclovir

Criteria

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.