Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy (PVBP)

This study has been completed.
Sponsor:
Information provided by:
Universidad de la Republica
ClinicalTrials.gov Identifier:
NCT00561106
First received: November 19, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Bell´s Palsy
Drug: prednisone- valacyclovir
Drug: prednisone-placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment Bell´s Palsy: Prednisone vs Prednisone Valacyclovir

Resource links provided by NLM:


Further study details as provided by Universidad de la Republica:

Primary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: December 2002
Study Completion Date: December 2003
Arms Assigned Interventions
Active Comparator: 1 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.
Placebo Comparator: 2 Drug: prednisone-placebo
prednisone, a dose of 1 mg/kg body weight was given daily for 7 days

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).

  Eligibility

Ages Eligible for Study:   14 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561106

Locations
Uruguay
Hospital de clinicas
Montevideo, Uruguay, 11600
Sponsors and Collaborators
Universidad de la Republica
Investigators
Principal Investigator: Maria C Vazquez, Dr. Hospital de Clinicas Facultad de Medicina Universidad de la Republica
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00561106     History of Changes
Other Study ID Numbers: HC 6-8-02
Study First Received: November 19, 2007
Last Updated: November 19, 2007
Health Authority: Uruguay: Comite de Etica

Keywords provided by Universidad de la Republica:
Bell´s palsy
prednisone
valacyclovir

Additional relevant MeSH terms:
Bell Palsy
Facial Paralysis
Paralysis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Prednisone
Valacyclovir
Acyclovir
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 31, 2014