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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 : September 16, 2020
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 recovery of complete 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 was submitted to the following clinical evaluation using House and Brackmann 6 facial function scoring system and Synnybrook grading system. Neurophysiological assessment of facial nerve and muscles was done before and after the end of treatment, then after the end of first and second month of treatment. EMG was 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 significant in terms of poor prognosis. Nerve conduction study of facial nerves of both sides using concentric needle electrode. Trigeminal Blink reflex for both sides of the face. Facial functional recovery was defined as "good" or "complete" using the same criteria used in the 2001 practice guideline. An outcome of grade I or II was considered a good recovery using the House and Brackmann 6 facial function scoring system

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

Detailed Description:
The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in recovery of complete 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 was submitted to the following clinical evaluation using House and Brackmann 6 facial function scoring system and Synnybrook grading system. Neurophysiological assessment of facial nerve and muscle was done before and after the end of treatment, then after the end of first and second month of treatment. EMG was 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 significant in terms of poor prognosis. Nerve conduction study of facial nerves of both sides using concentric needle electrode. Trigeminal Blink reflex for both sides of the face. Facial functional recovery was defined as "good" or "complete" using the same criteria used in the 2001 practice guideline. An outcome of grade I or II was considered a good recovery using the House and Brackmann 6 facial function scoring system

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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: Steroid 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: Steroid group (prednisolone 60 mg /day IM /IV), Steroid plus Antiviral 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.
Other Name: Steroid group (Prednisolone), Steroid plus Antiviral group (Prednisolone + acyclovir)

Active Comparator: Steroid + Antiviral 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: Steroid group (prednisolone 60 mg /day IM /IV), Steroid plus Antiviral 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.
Other Name: Steroid group (Prednisolone), Steroid plus Antiviral group (Prednisolone + acyclovir)




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 ]
    Measurment of facial n. coduction



Information from the National Library of Medicine

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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):
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Responsible Party: Eman M. Khedr, Professor, Assiut University
ClinicalTrials.gov Identifier: NCT02328079    
Other Study ID Numbers: Antiviral in facial palsy
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Keywords provided by Eman M. Khedr, Assiut University:
Facial Palsy (acute), Acyclovir, Prednisolone
Additional relevant MeSH terms:
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Bell Palsy
Facial Paralysis
Paralysis
Facies
Neurologic Manifestations
Nervous System Diseases
Disease Attributes
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Acyclovir
Antiviral Agents
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal