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Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy

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ClinicalTrials.gov Identifier: NCT02328079
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Eman M. Khedr, Assiut University

Brief Summary:
The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in complete recovery of facial Palsy. Fifty patients (Males and females) with acute Facial Palsy within the first 3 days of onset with age ranged from 15-60 years old. Each patient submitted to the following clinical evaluation using House and Brackmann6 facial function scoring system and Synnybrook grading system neurophysiological assessment of facial nerve and muscles before and after the end of treatment and then after the end of first and second month of treatment. EMG will be done for facial muscles of both sides beside measuring facial nerve excitability to determine the excitation threshold by recording the minimum electrical stimulus required to produce visible muscle contraction. A difference greater than 3.5 mA between the affected and unaffected side is considered to be significant in terms of poor prognosis. Nerve conduction study of facial nerves of both sides using concentric needle electrode. Trigeminal Blink reflex for both side of the face. Facial functional recovery was defined as "good" or "complete" using the same criteria used in the 2001 practice guideline. Using the House and Brackmann6 facial function scoring system, we considered an outcome of grade I or II a good recovery.

Condition or disease Intervention/treatment Phase
Facial Palsy Drug: Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antiviral Treatment in Facial Palsy. Randomized Control Trial
Study Start Date : April 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014


Arm Intervention/treatment
Active Comparator: First group
prednisolone 60 mg /day IM /IV for 6 consecutive days) then reduced by 10 mg /day (for a total treatment time for 12 days)
Drug: Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)
Group allocations: First group (prednisolone 60 mg /day IM /IV), second group (Prednisolone IM/ IV 60 mg /day + IV acyclovir 500 mg three time /day for 6 consecutive days) then reduced by 10 mg /day (for a total treatment time for 12 days) were placed in serially-numbered opaque closed envelopes. Each patient was placed in the appropriate group after opening the corresponding sealed envelope.

Active Comparator: Second group
Prednisolone IM/ IV 60 mg /day + IV acyclovir 500 mg three time /day for 6 consecutive days) then reduced by 10 mg /day (for a total treatment time for 12 days)
Drug: Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)
Group allocations: First group (prednisolone 60 mg /day IM /IV), second group (Prednisolone IM/ IV 60 mg /day + IV acyclovir 500 mg three time /day for 6 consecutive days) then reduced by 10 mg /day (for a total treatment time for 12 days) were placed in serially-numbered opaque closed envelopes. Each patient was placed in the appropriate group after opening the corresponding sealed envelope.




Primary Outcome Measures :
  1. Facial muscle function using clinical scale [ Time Frame: 2 months ]
    Evaluations of facial muscle function using clinical scale were performed blindly by a neurologist who was unaware of the type of treatment of which the patient had received


Secondary Outcome Measures :
  1. Nerve conduction study of facial nerve. [ Time Frame: 2 months ]


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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute onset facial palsy within the first three days of onset. Age ranged from 15-60 years old

Exclusion Criteria:

  • Patients with brittle diabetes mellitus, Morbid obesity, renal or liver impairment, osteopenia, prior history of steroid intolerance.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eman M. Khedr, Professor, Assiut University
ClinicalTrials.gov Identifier: NCT02328079     History of Changes
Other Study ID Numbers: Antiviral in facial palsy
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Eman M. Khedr, Assiut University:
Facial Palsy (acute), Acyclovir, Prednisolone

Additional relevant MeSH terms:
Paralysis
Facial Paralysis
Bell Palsy
Facies
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Antiviral Agents
Acyclovir
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs