An Early Phase 1 interventional study of Oral Corticosteroids and Oral antivirals in Bell Palsy, sponsored by NYU Langone Health. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-29.
Sponsored by NYU Langone Health · Early Phase 1, Interventional, and Treatment
This is a randomized, single blinded, non-placebo controlled that will compare one group of Bells Palsy patients receiving the current standard of care including oral corticosteroids and oral antivirals against an experimental group receiving the current standard of care in addition to hyperbaric oxygen therapy. Outcome assessment will be based on both objective analyses of facial movements as well as subjective quality of life scales.
85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.
Browse Bell Palsy studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
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Exclusion Criteria:
Reference Therapy
Drug: Oral Corticosteroids · Drug: Oral antivirals
Reference therapy in addition to Hyperbaric Oxygen Therapy
Drug: Oral Corticosteroids · Drug: Oral antivirals · Device: Hyperbaric Oxygen Therapy
Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg
acyclovir 400mg: one pill 4 times daily for 7 days
2.4atm administered for twice daily dives for 5 days, 10 dives total. To be begun in the first 1 week after onset of paralysis.
Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care Group
Time frame: 3, 6 and 12 months
Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care + Hyperbaric Oxygen Therapy on Bells Palsy (HBOT) Group
Time frame: 3, 6 and 12 months
Short Form 36 (SF-36) Score Standard of Care Group
As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36). The eight sections are: vitality physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health
Time frame: 3, 6 and 12 months
Short Form 36 (SF-36) Score Standard of Care + HBOT
As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36). The eight sections are: vitality physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health
Time frame: 3, 6 and 12 months
Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care Group
Used to assess facial impairment and disability after facial paralysis. It involves 15 statements, each using a five-item Likert scale. A participant circles the most appropriate response to a given statement, whereby 1 corresponds to the lowest function and 5 corresponds to the highest function. Statements are grouped into six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. A score from 0 (worst) to 100 (best) is calculated.
Time frame: 3, 6 and 12 months
Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care + HBOT
Used to assess facial impairment and disability after facial paralysis. It involves 15 statements, each using a five-item Likert scale. A participant circles the most appropriate response to a given statement, whereby 1 corresponds to the lowest function and 5 corresponds to the highest function. Statements are grouped into six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. A score from 0 (worst) to 100 (best) is calculated.
Time frame: 3, 6 and 12 months
Facial Disability Index (FDI) Score Standard of Care Group
Assesses facial neuromuscular dysfunction. Consists of 10 questions regarding physical function scoring difficulty on a scale of 2-5; 5 being "no difficulty" and 2 being "much difficulty"
Time frame: 3, 6 and 12 months
Facial Disability Index (FDI) Score Standard of Care + HBOT
Assesses facial neuromuscular dysfunction. Consists of 10 questions regarding physical function scoring difficulty on a scale of 2-5; 5 being "no difficulty" and 2 being "much difficulty"
Time frame: 3, 6 and 12 months
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Only as pertains to study results, will be shared only during publication.
Supporting information: Study protocol
Time frame: Immediately following publication. No end date.
Access criteria: Only shared with publication.
No publications or documents are linked to this record.
Start is estimated for Aug 2019; primary completion for Jun 2020, 10 months later.
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This study is withdrawn, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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