Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy

NCT ID: NCT00561106

Last Updated: 2007-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2003-12-31

Brief Summary

Since steroids carry a moderate beneficial effect in Bell's palsy, and to address this question, valacyclovir was added to prednisone for the treatment of this condition.

Detailed Description

Between December 2002 and December 2003, a total of 52 subjects with BP were evaluated, 42 fulfilled the inclusion criteria and entered the study, 1 patient was lost to follow-up after the first visit, leaving a total of 41 patients with complete clinical follow-up.

To be included in the study, patients had to be evaluated within the first 72 hours and could have no contraindications to steroid or valacyclovir therapy.

Patients were randomly assigned to either the prednisone-valacyclovir (group 1) or the prednisone-placebo group (group 2) Among the 41 patients completing the study, 19 pertenecian al group 1 and 21 group 2 Both groups received prednisone, a dose of 1 mg/kg body weight was given daily for 7 days (one single dose after breakfast). The treatment was tapered over the next 14 days. Those taking valacyclovir received 1000 mg in two daily doses for 7 days. All subjects were instructed about eye protection and lubrication were followed at regular intervals until recovery or for a minimum period of 3 months. Follow-up included examination at 1, 2, 4, 8 and 12 weeks after the first visit. Patients with incomplete recovery at 3 months were controlled until complete recovery or stabilization of the paralysis. All subjects were evaluated for laboratories parameters. Routine blood count, blood sugar, and liver function tests were performed at first visit.

There were no severe side effects attributable to the valacyclovir-prednisone treatment in this study.

Informed consent was obtained from all patients. Facial nerve function was assessed using the facial grading system (FGS) The scale used provides a quantitative score with three components; resting symmetry, symmetry of voluntary movement and synkinesis and a composite score was obtained.

Student's t-test was employed for quantitative….variables. Comparison of treatment results between both groups was performed by….means of an analysis of variance (ANOVA) test of two ways (therapy and time).

All statistical tests were considered received the same level of significance (P = 0.05).

Conditions

Bell´s Palsy

Keywords

Bell´s palsy; prednisone; valacyclovir

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

prednisone- valacyclovir

Intervention Type: DRUG

prednisone, a dose of 1 mg/kg body weight was given daily for 7 days. The treatment was tapered over the next 14 days. Those taking valacyclovir received 1000 mg in two daily doses for 7 days.

2

Group Type: PLACEBO_COMPARATOR

prednisone-placebo

Intervention Type: DRUG

prednisone, a dose of 1 mg/kg body weight was given daily for 7 days

Interventions

prednisone- valacyclovir

prednisone, a dose of 1 mg/kg body weight was given daily for 7 days. The treatment was tapered over the next 14 days. Those taking valacyclovir received 1000 mg in two daily doses for 7 days.

Intervention Type: DRUG

prednisone-placebo

prednisone, a dose of 1 mg/kg body weight was given daily for 7 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with Bell´s palsy evaluated within the first 72 hours.

Exclusion Criteria

• Peptic ulcer
• Tuberculosis
• Moderate or severe diabetes
• Moderate or severe hypertension
• Glaucoma
• Manifest cardiac disease
• Psychosis
• Renal or hepatic dysfunction, and
• Pregnancy.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de la Republica

OTHER

Sponsor Role: lead

Principal Investigators

Maria C Vazquez, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas Facultad de Medicina Universidad de la Republica

Locations

Hospital de clinicas

Montevideo, Montevideo Department, Uruguay

Countries

Uruguay

Other Identifiers

HC 6-8-02

Identifier Type: -

Identifier Source: org_study_id