## Protocol Section
### Identification Module
**NCT ID:** NCT02328079

**Brief Title:** Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy

**Official Title:** Antiviral Treatment in Facial Palsy. Randomized Control Trial

#### Organization Study ID Info
**ID:** Antiviral in facial palsy
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2014-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-09-16

**Type:** ACTUAL

**Last Update Submit Date:** 2020-09-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-11

**Type:** ACTUAL

#### Start Date
**Date:** 2013-04

**Status Verified Date:** 2020-09

#### Study First Post Date
**Date:** 2014-12-31
**Type:** ESTIMATED
**Study First Submit Date:** 2014-12-10
**Study First Submit QC Date:** 2014-12-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Eman M. Khedr

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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

**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

### Conditions Module

**Conditions:**

- Facial Palsy

**Keywords:**

- Facial Palsy (acute), Acyclovir, Prednisolone

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** prednisolone 60 mg /day IM /IV for 6 consecutive days then reduced by 10 mg /day (for a total treatment time for 12 days)

**Intervention Names:**

- Drug: Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)

**Label:** Steroid Group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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)

**Intervention Names:**

- Drug: Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)

**Label:** Steroid + Antiviral Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Steroid + Antiviral Group

- Steroid Group

**Description:** 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.

**Name:** Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)

**Other Names:**

- Steroid group (Prednisolone), Steroid plus Antiviral group (Prednisolone + acyclovir)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Facial muscle function using clinical scale

**Time Frame:** 2 months

#### Secondary Outcomes

**Description:** Measurment of facial n. coduction

**Measure:** Nerve conduction study of facial nerve.

**Time Frame:** 2 months

### Eligibility Module

**Eligibility 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.

**Maximum Age:** 60 Years

**Minimum Age:** 15 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### References Module

#### References

**Citation:** Khedr EM, Badry R, Ali AM, Abo El-Fetoh N, El-Hammady DH, Ghandour AM, Abdel-Haleem A. Steroid/Antiviral for the treatment of Bell's palsy: Double blind randomized clinical trial. Restor Neurol Neurosci. 2016 Nov 22;34(6):897-905. doi: 10.3233/RNN-150605.

**PMID:** 27689547

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000006566

- Term: Herpesviridae Infections

- ID: D000004266

- Term: DNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000005155

- Term: Facial Nerve Diseases

- ID: D000003389

- Term: Cranial Nerve Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13157

- Name: Paralysis

- Relevance: HIGH

- As Found: Palsy

- ID: M22138

- Name: Bell Palsy

- Relevance: HIGH

- As Found: Facial Palsy

- ID: M8301

- Name: Facial Paralysis

- Relevance: HIGH

- As Found: Facial Palsy

- ID: M21089

- Name: Facies

- Relevance: HIGH

- As Found: Facial

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9643

- Name: Herpesviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M8298

- Name: Facial Nerve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6605

- Name: Cranial Nerve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T707

- Name: Bell's Palsy

- Relevance: HIGH

- As Found: Facial Palsy

### Condition Browse Module - Meshes

- ID: D000020330

- Term: Bell Palsy

- ID: D000005158

- Term: Facial Paralysis

- ID: D000010243

- Term: Paralysis

- ID: D000019066

- Term: Facies

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000018696

- Term: Neuroprotective Agents

- ID: D000020011

- Term: Protective Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M14120

- Name: Prednisolone

- Relevance: HIGH

- As Found: Vein

- ID: M11749

- Name: Methylprednisolone

- Relevance: HIGH

- As Found: Vein

- ID: M3567

- Name: Acyclovir

- Relevance: HIGH

- As Found: Aqueous

- ID: M1833

- Name: Methylprednisolone Acetate

- Relevance: HIGH

- As Found: Vein

- ID: M11750

- Name: Methylprednisolone Hemisuccinate

- Relevance: HIGH

- As Found: Vein

- ID: M229449

- Name: Prednisolone acetate

- Relevance: HIGH

- As Found: Vein

- ID: M211887

- Name: Prednisolone hemisuccinate

- Relevance: HIGH

- As Found: Vein

- ID: M248881

- Name: Prednisolone phosphate

- Relevance: HIGH

- As Found: Vein

- ID: M4314

- Name: Antiviral Agents

- Relevance: HIGH

- As Found: Intravesical

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20773

- Name: Neuroprotective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000212

- Term: Acyclovir

- ID: D000000998

- Term: Antiviral Agents

- ID: D000011239

- Term: Prednisolone

- ID: D000077555

- Term: Methylprednisolone Acetate

- ID: D000008775

- Term: Methylprednisolone

- ID: D000008776

- Term: Methylprednisolone Hemisuccinate

- ID: C000009935

- Term: Prednisolone acetate

- ID: C000021322

- Term: Prednisolone hemisuccinate

- ID: C000009022

- Term: Prednisolone phosphate

### Misc Info Module

- Version Holder: 2024-05-24
