Bell´s PalsyPVBPNCT00561106
Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy
A study testing prednisone- valacyclovir in people with Bell´s Palsy, run by Universidad de la Republica at 1 site in Uruguay.
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. Read more about this study
- Who is it for?
- Ages 14 to 82 years
- Conditions the study is for
- Bell´s Palsy
- What is being tested?
- prednisone- valacyclovir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUruguay
- Study dates
- Dec 2002to Dec 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 82 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Bell´s palsy evaluated within the first 72 hours.
Who cannot join
- Peptic ulcer
- Tuberculosis
- Moderate or severe diabetes
- Moderate or severe hypertension
- Glaucoma
- Manifest cardiac disease
Show all 9Show fewer
- Psychosis
- Renal or hepatic dysfunction, and
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- prednisone- valacyclovir, prednisone-placebo
- Keywords
- Bell´s palsy, prednisone, valacyclovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
prednisone-placeboDrug
prednisone, a dose of 1 mg/kg body weight was given daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: prednisone- valacyclovir |
| 2 | Placebo comparator | Not described Receives: Drug: prednisone-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startDec 2002
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell´s PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de la Republica
- Sponsor type
- University, hospital or other
- Investigators
- Maria C Vazquez, Dr., Principal investigator, Hospital de Clinicas Facultad de Medicina Universidad de la Republica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561106
- Sponsor's protocol ID
- HC 6-8-02
- Acronym
- PVBP
- Status last verified
- Nov 2007
- First submitted
- 19 Nov 2007
- Last updated
- 20 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Bell´s Palsy: Prednisone vs Prednisone Valacyclovir
- ClinicalTrials.gov ID
- NCT00561106
- Acronym / sponsor ID
- PVBP / HC 6-8-02
- Conditions
- Bell´s Palsy
- Keywords
- Bell´s palsy, prednisone, valacyclovir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad de la RepublicaUniversity, hospital or other
- Study start
- Dec 2002
- Study completion
- Dec 2003 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: prednisone- valacyclovir |
| 2 | Placebo comparator | Drug: prednisone-placebo |
Who may qualify
- Ages
- 14 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Bell´s palsy evaluated within the first 72 hours.
Key exclusion criteria (9 listed)
- Peptic ulcer
- Tuberculosis
- Moderate or severe diabetes
- Moderate or severe hypertension
- Glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prednisone- valacyclovirprednisone, 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. | Drug | 1 |
| prednisone-placeboprednisone, a dose of 1 mg/kg body weight was given daily for 7 days | Drug | 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2007.
Related trials for Bell´s Palsy
Enrolling by invitation
EXPLORING EFFECTIVENESS OF LOW LEVEL LASER THERAPY IN THE TREATMENT OF PATIENTS WITH BELLS PALSY
Bell Palsy, Bell's Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria C Vazquez, Dr. principal investigator
Hospital de Clinicas Facultad de Medicina Universidad de la Republica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prednisone- valacyclovir in people with Bell´s Palsy, run by Universidad de la Republica at 1 site in Uruguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2007.