Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients

NCT07116811 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: KY2025-137-02
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of steroids treatment compared with placebo in preserving facial nerve function after craniotomy in patients with vestibular schwannoma who have not received preoperative treatment and have good intraoperative facial nerve function.

Conditions

Vestibular Schwannoma; Facial Nerve Paralysis

Keywords

Steroids; Facial Nerve Function; Intraoperative Neurophysiological Monitoring; Randomized Controlled Trial; Facial Palsy

Outcome Measures

Primary Outcomes (1)

• Good facial nerve function (House-Brackmann grade I or II) at 90 days after surgery

  Defined as House-Brackmann grade I or II.

  at 90 (±7) days after surgery

Secondary Outcomes (9)

• Good facial nerve function (House-Brackmann grade I or II) at 10 days after surgery

  at 10 days after surgery

• Complete facial nerve function recovery (House-Brackmann grade I) at 90 days after surgery

  at 90 (±7) days after surgery

• Complete facial nerve function recovery (House-Brackmann grade I) at 10 days after surgery

  at 10 days after surgery

• Complete facial nerve function recovery (Sunnybrook scale 100 score) at 90 days after surgery

  at 90 (±7) days after surgery

• Complete facial nerve function recovery (Sunnybrook scale 100 score) at 10 days after surgery

  at 10 days after surgery

Study Arms (2)

Steroids Group

EXPERIMENTAL

Methylprednisolone sodium succinate (80 mg/day) on days 1-3 post-surgery, followed by prednisone acetate (20 mg/day) on days 4-10.

Drug: Steroids therapy

Placebo Group

PLACEBO COMPARATOR

Methylprednisolone sodium succinate placebo on days 1-3 post-surgery, followed by prednisone acetate placebo on days 4-10.

Drug: Placebo

Interventions

Steroids therapy DRUG

Methylprednisolone sodium succinate 80 mg powder dissolved in 100 mL of sodium chloride solution (intravenous infusion, once daily) from the day of surgery to day 3, followed by 20 mg of prednisone acetate (oral intake, once daily) from day 4 to day 10.

Steroids Group

Placebo DRUG

Methylprednisolone sodium succinate placebo powder dissolved in 100 mL of sodium chloride solution (intravenous infusion, once daily) from the day of surgery to day 3, followed by prednisone acetate placebo (oral intake, once daily) from day 4 to day 10.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years
• Diagnosed with untreated unilateral vestibular schwannoma
• No facial palsy before surgery (House-Brackmann grade I)
• Intraoperative neurophysiological monitoring confirms good facial nerve function preservation, defined as: a）Post-tumor resection, evoked compound muscle action potential amplitude \>420 μV under 0.05 mA stimulation；and b）The amplitude is \>60% of baseline value measured before dural opening
• Signed informed consent

You may not qualify if:

• Contraindications for craniotomy
• Patients requiring corticosteroids during the perioperative period, or with known corticosteroid contraindications
• Patients or first-degree relatives with a confirmed diagnosis of neurofibromatosis type 2 (NF2)
• Karnofsky Performance Status (KPS) score \<90 before disease onset
• Pregnant or planning to become pregnant during the study period
• Participation in other interventional clinical trials
• Judged unsuitable by the investigators

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Neuroma, Acoustic; Bell Palsy; Facial Paralysis

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wang Jia, PhD

CONTACT

8615510033866; jwttyy@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study adopted a double-blind design. Study drugs and placebos are identically packaged. The dosage form, size, color, weight, smell, and taste of the placebo were basically similar to those of the research drug, and there was no risk of blinding. Personnel involved in randomization or potentially exposed to treatment allocation (including pharmacy staff) are not involved in patient care, outcome assessment, or data analysis. Blinded investigators and outcome assessors remain unaware of treatment assignments throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Beijing Tiantan Hospital, Capital Medical University

Model Details: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Patients with untreated unilateral vestibular schwannoma and good preoperative facial nerve function will be randomized in a 1:1 ratio to receive either steroid therapy or placebo. All participants will undergo craniotomy with intraoperative neurophysiological monitoring to ensure adequate facial nerve function preservation. Treatment will be initiated on the day of surgery and continued for 10 days. The primary outcome is the proportion of patients with good facial nerve recovery at 90 days postoperatively.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)