Vestibular SchwannomaPhase 3SAF-NRVSNCT07116811
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
A Phase 3 study testing Steroids therapy in people with Vestibular Schwannoma and Facial Nerve Paralysis, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vestibular Schwannoma, Facial Nerve Paralysis
- What is being tested?
- Steroids therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to 30 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Wang Jia, PhD, 8615510033866, jwttyy@126.com
Wang Jia, PhD
About this study
Official title: The Effect of Steroids Treatment for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients (SAF-NRVS): a Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial
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.
Read the detailed description
Vestibular schwannoma (VS) is a benign tumor arising from the vestibular nerve. Surgical resection is a common treatment, and intraoperative neurophysiological monitoring (IONM) is widely used to protect facial nerve function. However, postoperative facial nerve paralysis remains a common complication, affecting patients' appearance, confidence, and quality of life.
Steroids are often used to reduce inflammation and edema in idiopathic facial palsy, but their efficacy and safety in post-surgical VS patients remain uncertain. The mechanism of post-surgical facial nerve dysfunction is more complex than idiopathic palsy and may involve physical traction, vascular compromise, or inflammatory injury.
This study (SAF-NRVS) is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Patients aged 18 to 70 years with a clinically confirmed untreated unilateral vestibular schwannoma will be enrolled. Eligible patients must have no preoperative facial paralysis (grade I according to the House-Brackmann grading system), and have good intraoperative facial nerve function as determined by intraoperative neurophysiological monitoring. Participants will be randomly divided into two groups in a 1:1 ratio. Intervention group (Steroids group) will receive 80 mg of methylprednisolone sodium succinate powder dissolved in 100 ml of sodium chloride (NaCl) solution by 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. Control group (Placebo group) will receive methylprednisolone sodium succinate placebo powder dissolved in 100 ml of NaCl solution by 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. The primary outcome measure is the proportion of patients with good facial nerve function recovery at 90 days after surgery, defined as grade 1 or 2 according to House-Brackmann grading system.
- Conditions
- Vestibular Schwannoma, Facial Nerve Paralysis
- Being tested
- Steroids therapy, Placebo
- Keywords
- Steroids, Facial Nerve Function, Intraoperative Neurophysiological Monitoring, Randomized Controlled Trial, Facial Palsy
- Medical subject headings
- Neuroma, Acoustic, Bell Palsy, Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroids therapyDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good facial nerve function (House-Brackmann grade I or II) at 90 days after surgery
Defined as House-Brackmann grade I or II.
Measured: at 90 (±7) days after surgery
Secondary outcomes (9)
Good facial nerve function (House-Brackmann grade I or II) at 10 days after surgery
Defined as House-Brackmann grade I or II.
Measured: at 10 days after surgery
Complete facial nerve function recovery (House-Brackmann grade I) at 90 days after surgery
Defined as House-Brackmann grade I
Measured: at 90 (±7) days after surgery
Complete facial nerve function recovery (House-Brackmann grade I) at 10 days after surgery
Defined as House-Brackmann grade I
Measured: at 10 days after surgery
Complete facial nerve function recovery (Sunnybrook scale 100 score) at 90 days after surgery
Sunnybrook Facial Grading System will be used. Score of 100 represents complete recovery.
Measured: at 90 (±7) days after surgery
Complete facial nerve function recovery (Sunnybrook scale 100 score) at 10 days after surgery
Sunnybrook Facial Grading System will be used. Score of 100 represents complete recovery.
Measured: at 10 days after surgery
Adverse events within 90 days
Measured: Within 90 (±7) days after surgery
Serious adverse events within 90 days
Measured: Within 90 (±7) days after surgery
Adverse events within 10 days
Measured: Within 10 days after surgery
Serious adverse events within 10 days
Measured: Within 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start9 Oct 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jia, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116811
- Sponsor's protocol ID
- KY2025-137-02
- Acronym
- SAF-NRVS
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Steroids Treatment for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients (SAF-NRVS): a Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial
- ClinicalTrials.gov ID
- NCT07116811
- Acronym / sponsor ID
- SAF-NRVS / KY2025-137-02
- Conditions
- Vestibular Schwannoma, Facial Nerve Paralysis
- Keywords
- Steroids, Facial Nerve Function, Intraoperative Neurophysiological Monitoring, Randomized Controlled Trial, Facial Palsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vestibular schwannoma (VS) is a benign tumor arising from the vestibular nerve. Surgical resection is a common treatment, and intraoperative neurophysiological monitoring (IONM) is widely used to protect facial nerve function. However, postoperative facial nerve paralysis remains a common complication, affecting patients' appearance, confidence, and quality of life.
Steroids are often used to reduce inflammation and edema in idiopathic facial palsy, but their efficacy and safety in post-surgical VS patients remain uncertain. The mechanism of post-surgical facial nerve dysfunction is more complex than idiopathic palsy and may involve physical traction, vascular compromise, or inflammatory injury.
This study (SAF-NRVS) is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Patients aged 18 to 70 years with a clinically confirmed untreated unilateral vestibular schwannoma will be enrolled. Eligible patients must have no preoperative facial paralysis (grade I according to the House-Brackmann grading system), and have good intraoperative facial nerve function as determined by intraoperative neurophysiological monitoring. Participants will be randomly divided into two groups in a 1:1 ratio. Intervention group (Steroids group) will receive 80 mg of methylprednisolone sodium succinate powder dissolved in 100 ml of sodium chloride (NaCl) solution by 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. Control group (Placebo group) will receive methylprednisolone sodium succinate placebo powder dissolved in 100 ml of NaCl solution by 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. The primary outcome measure is the proportion of patients with good facial nerve function recovery at 90 days after surgery, defined as grade 1 or 2 according to House-Brackmann grading system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Steroids Group | Experimental | Drug: Steroids therapyMethylprednisolone sodium succinate (80 mg/day) on days 1-3 post-surgery, followed by prednisone acetate (20 mg/day) on days 4-10. |
| Placebo Group | Placebo comparator | Drug: PlaceboMethylprednisolone sodium succinate placebo on days 1-3 post-surgery, followed by prednisone acetate placebo on days 4-10. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 70 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steroids therapyMethylprednisolone 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. | Drug | Steroids Group |
| PlaceboMethylprednisolone 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. | Drug | Placebo Group |
Primary outcome
Good facial nerve function (House-Brackmann grade I or II) at 90 days after surgery
Time frame: at 90 (±7) days after surgery
Defined as House-Brackmann grade I or II.
9 secondary outcomes
Good facial nerve function (House-Brackmann grade I or II) at 10 days after surgery
Time frame: at 10 days after surgery
Complete facial nerve function recovery (House-Brackmann grade I) at 90 days after surgery
Time frame: at 90 (±7) days after surgery
Complete facial nerve function recovery (House-Brackmann grade I) at 10 days after surgery
Time frame: at 10 days after surgery
Complete facial nerve function recovery (Sunnybrook scale 100 score) at 90 days after surgery
Time frame: at 90 (±7) days after surgery
Complete facial nerve function recovery (Sunnybrook scale 100 score) at 10 days after surgery
Time frame: at 10 days after surgery
Adverse events within 90 days
Time frame: Within 90 (±7) days after surgery
Serious adverse events within 90 days
Time frame: Within 90 (±7) days after surgery
Adverse events within 10 days
Time frame: Within 10 days after surgery
Serious adverse events within 10 days
Time frame: Within 10 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Steroids therapy in people with Vestibular Schwannoma and Facial Nerve Paralysis, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Jia, PhD (8615510033866, jwttyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good facial nerve function (House-Brackmann grade I or II) at 90 days after surgery (time frame: at 90 (±7) days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.