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Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy (PVBP)
This study has been completed.
Study NCT00561106   Information provided by Universidad de la Republica
First Received: November 19, 2007   No Changes Posted

November 19, 2007
November 19, 2007
December 2002
 
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. [ Time Frame: 6 months ]
Same as current
No Changes Posted
 
 
 
Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy
Treatment Bell´s Palsy: Prednisone vs Prednisone Valacyclovir

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.

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).

 
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Bell´s Palsy
  • Drug: prednisone- valacyclovir
  • Drug: prednisone-placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
42
December 2003
 

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.
Both
14 Years to 82 Years
No
Contact information is only displayed when the study is recruiting subjects
Uruguay
 
NCT00561106
 
HC 6-8-02
Universidad de la Republica
 
Principal Investigator: Maria C Vazquez, Dr. Hospital de Clinicas Facultad de Medicina Universidad de la Republica
Universidad de la Republica
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP