Multiple sclerosis and related disorders · 2026
Adjunctive gypenosides for acute optic neuritis: A prematurely terminated randomized, double-blind, placebo-controlled pilot trial in a cohort with frequent AQP4-IgG positivity.
Клиническое исследование II фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Lu Yijia, Zhao Mukun, Luo Wenjing, Du Yi
Аннотация
BACKGROUND: Gypenosides are neuroprotective in experimental optic neuritis, but human data are lacking.
METHODS: In this single-center, double-blind, placebo-controlled randomized pilot trial, adults with first-episode optic neuritis in the study eye within 28 days received standard corticosteroids and were assigned to gypenosides (180 mg/day for 10 days) or placebo. Planned enrollment was 28, but the trial stopped after 10 randomizations. The primary outcome was peripapillary retinal nerve fiber layer (pRNFL) thickness at 6 months. The registered secondary structural outcome was total macular volume; macular ganglion cell-inner plexiform layer (mGCIPL) thickness was exploratory. Mixed-effects models adjusted for aquaporin 4 immunoglobulin G (AQP4-IgG) serostatus.
RESULTS: Ten participants were randomized (gypenosides n = 6; placebo n = 4), nine contributed post-baseline data, and six were AQP4-IgG positive. At 6 months, adjusted between-group differences were +16.2 μm for pRNFL thickness (95% CI -16.3 to 48.6; P = 0.274) and +0.034 mm³ for total macular volume (95% CI -0.166 to 0.234; P = 0.696). Exploratory mGCIPL change showed a nominal difference (+18.0 μm, 95% CI 7.8 to 28.3; nominal P = 0.004), without consistent functional benefit.
CONCLUSIONS: This prematurely terminated pilot trial was severely underpowered and did not meet the pRNFL primary endpoint. The exploratory mGCIPL finding should not be interpreted as evidence of efficacy. The study provides feasibility and endpoint information that may inform the design of future antibody-stratified trials.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT02976766).
METHODS: In this single-center, double-blind, placebo-controlled randomized pilot trial, adults with first-episode optic neuritis in the study eye within 28 days received standard corticosteroids and were assigned to gypenosides (180 mg/day for 10 days) or placebo. Planned enrollment was 28, but the trial stopped after 10 randomizations. The primary outcome was peripapillary retinal nerve fiber layer (pRNFL) thickness at 6 months. The registered secondary structural outcome was total macular volume; macular ganglion cell-inner plexiform layer (mGCIPL) thickness was exploratory. Mixed-effects models adjusted for aquaporin 4 immunoglobulin G (AQP4-IgG) serostatus.
RESULTS: Ten participants were randomized (gypenosides n = 6; placebo n = 4), nine contributed post-baseline data, and six were AQP4-IgG positive. At 6 months, adjusted between-group differences were +16.2 μm for pRNFL thickness (95% CI -16.3 to 48.6; P = 0.274) and +0.034 mm³ for total macular volume (95% CI -0.166 to 0.234; P = 0.696). Exploratory mGCIPL change showed a nominal difference (+18.0 μm, 95% CI 7.8 to 28.3; nominal P = 0.004), without consistent functional benefit.
CONCLUSIONS: This prematurely terminated pilot trial was severely underpowered and did not meet the pRNFL primary endpoint. The exploratory mGCIPL finding should not be interpreted as evidence of efficacy. The study provides feasibility and endpoint information that may inform the design of future antibody-stratified trials.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT02976766).