NCT00561106

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
Last Updated

November 20, 2007

Status Verified

November 1, 2007

First QC Date

November 19, 2007

Last Update Submit

November 19, 2007

Conditions

Bell´s Palsy

Keywords

Bell´s palsyprednisonevalacyclovir

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: prednisone- valacyclovir

2

PLACEBO COMPARATOR
Drug: prednisone-placebo

Interventions

prednisone- valacyclovirDRUG

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.

1
prednisone-placeboDRUG

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

2

Eligibility Criteria

Age14 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de clinicas

Montevideo, Montevideo Department, 11600, Uruguay

Location

Study Officials

  • Maria C Vazquez, Dr.

    Hospital de Clinicas Facultad de Medicina Universidad de la Republica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 20, 2007

Study Start

December 1, 2002

Study Completion

December 1, 2003

Last Updated

November 20, 2007

Record last verified: 2007-11

Locations

UR(1)