Optic NeuritisPhase 2NCT02976766
Adjunctive Gypenosides for Acute Optic Neuritis
A Phase 2 study testing Gypenosides in people with Optic Neuritis, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
Trial summary
This pilot randomized, double-blind, placebo-controlled trial evaluated whether short-course adjunctive gypenosides, added to standard corticosteroid treatment, may preserve retinal structural outcomes in adults with acute optic neuritis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- Gypenosides
- 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
- 10 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2017to 30 Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female Chinese patients aged ≥18 to ≤60 years
- Patients with a first episode of optic neuritis in the eye of interest
- First symptoms of optic neuritis ≤28 days prior to the first administration of investigational product
- Best corrected visual acuity in the eye of interest ≤0.8
Who cannot join
- Pre-existing multiple sclerosis MS or NMO
- Refractive media opacity
- Hyperopia >5 diopters, myopia <-5 diopters, or astigmatism >3 diopters
- Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial
- Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc)
- Existing other retina or optic nerve diseases
- Pregnant or females who plan to be pregnant during study
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
About this study
Official title: Adjunctive Gypenosides for Acute Optic Neuritis: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial
This pilot randomized, double-blind, placebo-controlled trial evaluated whether short-course adjunctive gypenosides, added to standard corticosteroid treatment, may preserve retinal structural outcomes in adults with acute optic neuritis.
Read the detailed description
This was a single-center, randomized, double-blind, placebo-controlled pilot trial in adults with a first episode of acute optic neuritis within 28 days of symptom onset. Participants received standard corticosteroid treatment and were randomized in a 1:1 ratio to adjunctive oral gypenosides 180 mg/day for 10 days or matching placebo.
The trial was designed as a pilot study to estimate structural treatment effects and variability for future neuroprotection trials in optic neuritis. The primary structural outcome was peripapillary retinal nerve fiber layer thickness in the prespecified index eye at Month 6 measured by spectral-domain OCT. Secondary outcomes included total macular volume, best-corrected visual acuity, visual evoked potentials, visual-field measures, and safety outcomes.
Macular ganglion cell-inner plexiform layer thickness was analyzed as an exploratory segmentation-derived macular structural endpoint.
Baseline aquaporin 4 immunoglobulin G serostatus was assessed. Myelin oligodendrocyte glycoprotein immunoglobulin G testing was not included in the original study design.
- Conditions
- Optic Neuritis
- Being tested
- Gypenosides, Placebo
- Keywords
- Neuroprotection, Clinical trial, Traditional Chinese medicine, Axonal loss, Jiaogulan, Gynostemma pentaphyllum, Optical coherence tomography
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GypenosidesDrug
Also called Jiaogulan Zongdai
Participants received gypenosides 180 mg/day, given as 60 mg three times daily for 10 days, started on the first day of intravenous methylprednisolone. All participants also received standard corticosteroid treatment.
PlaceboDrug
Participants received matching placebo capsules three times daily for 10 days, started on the first day of intravenous methylprednisolone. All participants also received standard corticosteroid treatment.
| Study group | Role | What they receive |
|---|---|---|
| Gypenosides | Experimental | Participants received adjunctive oral gypenosides for 10 days in addition to standard corticosteroid treatment. Receives: Drug: Gypenosides |
| Placebo | Placebo comparator | Participants received matching placebo capsules for 10 days in addition to standard corticosteroid treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean peripapillary retinal nerve fiber layer thickness
Peripapillary retinal nerve fiber layer thickness in the prespecified index eye at Month 6, measured in micrometers by spectral-domain OCT. The index eye was the affected study eye; in bilateral cases, the eye with worse baseline best-corrected visual acuity was used, and if visual acuity was equal, the right eye was used. Higher values indicate less retinal nerve fiber layer thinning.
Measured: 6 months
Secondary outcomes (5)
Total macular volume
Total macular volume in the prespecified index eye at Month 6, measured by spectral-domain OCT macular volume scans. Higher values indicate greater macular volume. Macular ganglion cell-inner plexiform layer thickness was not a registered secondary outcome and was analyzed only as an exploratory segmentation-derived macular structural endpoint.
Measured: 6 months
Best-corrected visual acuity
Best-corrected visual acuity in the prespecified index eye at Month 6, assessed using a high-contrast tumbling-E chart and converted to logarithm of the minimum angle of resolution for analysis.
Measured: 6 months
Latency and amplitude of visual evoked potentials
Pattern-reversal visual evoked potentials in the prespecified index eye at Month 6. P100 latency was measured in milliseconds, and N75-P100 peak-to-peak amplitude was measured in microvolts.
Measured: 6 months
Mean visual field defect
Visual-field mean defect or mean deviation in the prespecified index eye at Month 6, measured in decibels using automated perimetry.
Measured: 6 months
Number of participants with adverse events
Number of participants with adverse events or serious adverse events from screening through the end of study follow-up. Relationship to study medication was assessed by investigators.
Measured: Screening until end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start4 Feb 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Why it stopped: Slow recruitment and an unexpectedly high proportion of AQP4-IgG-positive optic neuritis on masked feasibility review limited feasibility. No interim efficacy analysis was performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to adjunctive gypenosides or matching placebo in parallel groups. Both groups received standard corticosteroid treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Du, First Affiliated Hospital of Guangxi Medical University
- Investigators
- Yi Du, MD, Principal investigator, The First Affiliated Hospital of Guangxi Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976766
- Sponsor's protocol ID
- GXON-001
- Status last verified
- May 2026
- First submitted
- 24 Nov 2016
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu Y, Zhao M, Luo W, Du Y. Adjunctive gypenosides for acute optic neuritis: A prematurely terminated randomized, double-blind, placebo-controlled pilot trial in a cohort with frequent AQP4-IgG positivity. Mult Scler Relat Disord. 2026 Jun 27;113:107346. doi: 10.1016/j.msard.2026.107346. Online ahead of print.
PubMed 42398278
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Gypenosides for Acute Optic Neuritis: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT02976766
- Acronym / sponsor ID
- GXON-001
- Conditions
- Optic Neuritis
- Keywords
- Neuroprotection, Clinical trial, Traditional Chinese medicine, Axonal loss, Jiaogulan, Gynostemma pentaphyllum, Optical coherence tomography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment and an unexpectedly high proportion of AQP4-IgG-positive optic neuritis on masked feasibility review limited feasibility. No interim efficacy analysis was performed.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 4 Feb 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 29 Nov 2016 (estimated)
- 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.
This pilot randomized, double-blind, placebo-controlled trial evaluated whether short-course adjunctive gypenosides, added to standard corticosteroid treatment, may preserve retinal structural outcomes in adults with acute optic neuritis.
Detailed description
This was a single-center, randomized, double-blind, placebo-controlled pilot trial in adults with a first episode of acute optic neuritis within 28 days of symptom onset. Participants received standard corticosteroid treatment and were randomized in a 1:1 ratio to adjunctive oral gypenosides 180 mg/day for 10 days or matching placebo.
The trial was designed as a pilot study to estimate structural treatment effects and variability for future neuroprotection trials in optic neuritis. The primary structural outcome was peripapillary retinal nerve fiber layer thickness in the prespecified index eye at Month 6 measured by spectral-domain OCT. Secondary outcomes included total macular volume, best-corrected visual acuity, visual evoked potentials, visual-field measures, and safety outcomes.
Macular ganglion cell-inner plexiform layer thickness was analyzed as an exploratory segmentation-derived macular structural endpoint.
Baseline aquaporin 4 immunoglobulin G serostatus was assessed. Myelin oligodendrocyte glycoprotein immunoglobulin G testing was not included in the original study design.
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
- Participants were randomized in a 1:1 ratio to adjunctive gypenosides or matching placebo in parallel groups. Both groups received standard corticosteroid treatment.
| Arm | Type | Receives |
|---|---|---|
| Gypenosides | Experimental | Drug: GypenosidesParticipants received adjunctive oral gypenosides for 10 days in addition to standard corticosteroid treatment. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo capsules for 10 days in addition to standard corticosteroid treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female Chinese patients aged ≥18 to ≤60 years
- Patients with a first episode of optic neuritis in the eye of interest
- First symptoms of optic neuritis ≤28 days prior to the first administration of investigational product
- Best corrected visual acuity in the eye of interest ≤0.8
Key exclusion criteria (7 listed)
- Pre-existing multiple sclerosis MS or NMO
- Refractive media opacity
- Hyperopia >5 diopters, myopia <-5 diopters, or astigmatism >3 diopters
- Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial
- Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc)
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 |
|---|---|---|
| GypenosidesAlso: Jiaogulan ZongdaiParticipants received gypenosides 180 mg/day, given as 60 mg three times daily for 10 days, started on the first day of intravenous methylprednisolone. All participants also received standard corticosteroid treatment. | Drug | Gypenosides |
| PlaceboParticipants received matching placebo capsules three times daily for 10 days, started on the first day of intravenous methylprednisolone. All participants also received standard corticosteroid treatment. | Drug | Placebo |
Primary outcome
Mean peripapillary retinal nerve fiber layer thickness
Time frame: 6 months
Peripapillary retinal nerve fiber layer thickness in the prespecified index eye at Month 6, measured in micrometers by spectral-domain OCT. The index eye was the affected study eye; in bilateral cases, the eye with worse baseline best-corrected visual acuity was used, and if visual acuity was equal, the right eye was used. Higher values indicate less retinal nerve fiber layer thinning.
5 secondary outcomes
Total macular volume
Time frame: 6 months
Best-corrected visual acuity
Time frame: 6 months
Latency and amplitude of visual evoked potentials
Time frame: 6 months
Mean visual field defect
Time frame: 6 months
Number of participants with adverse events
Time frame: Screening until end of study
Results and safety
The study was stopped early (reason given: Slow recruitment and an unexpectedly high proportion of AQP4-IgG-positive optic neuritis on masked feasibility review limited feasibility. No interim efficacy analysis was performed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 42398278Lu Y, Zhao M, Luo W, Du Y. Adjunctive gypenosides for acute optic neuritis: A prematurely terminated randomized, double-blind, placebo-controlled pilot trial in a cohort with frequent AQP4-IgG positivity. Mult Scler Relat Disord. 2026 Jun 27;113:107346. doi: 10.1016/j.msard.2026.107346. Online ahead of print.
Related trials for Optic Neuritis
RecruitingObservational study
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
Active, not recruitingObservational study
Biobank For MS And Other Demyelinating Diseases
Multiple Sclerosis, Transverse Myelitis
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. This study is not recruiting at the moment.
Yi Du, MD principal investigator
The First Affiliated Hospital of Guangxi Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gypenosides in people with Optic Neuritis, run by First Affiliated Hospital of Guangxi Medical University 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 4 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: stopped early, as of the sponsor's last update on 20 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment and an unexpectedly high proportion of AQP4-IgG-positive optic neuritis on masked feasibility review limited feasibility. No interim efficacy analysis was performed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean peripapillary retinal nerve fiber layer thickness (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02976766, which also lists 1 linked publication.
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 20 May 2026.