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

Bell´s Palsy Clinical Trial

— PVBP  

Official title:

Treatment Bell´s Palsy: Prednisone vs Prednisone Valacyclovir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561106
• Other study ID #: HC 6-8-02
• Status: Completed
• Phase: N/A
• First received: November 19, 2007
• Last updated: November 19, 2007
• Start date: December 2002
• Est. completion date: December 2003

Study information

• Verified date: November 2007
• Source: Universidad de la Republica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uruguay: Comite de Etica
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 82 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bell Palsy
• Bell´s Palsy
• Facial Paralysis

Intervention

Drug:
• 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.
• prednisone-placebo
prednisone, a dose of 1 mg/kg body weight was given daily for 7 days

Locations

Country	Name	City	State
Uruguay	Hospital de clinicas	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de la Republica

Country where clinical trial is conducted

Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The following parameters were used to evaluate the final result: grade of recovery, and sequelae.Facial nerve function was assessed using the facial grading system (FGS) Normal recovery was defined as the return of facial function to FGS 90 or more.		6 months