Efficacy & Safety Study of Bilateral IVT Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year

Model scores of the 29,894 trials active now.

Model score 16% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (734 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-07-23. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subjectsubjectslosseyeto assess
  Phrases that lowered it: and safetyefficacy andsafety ofthe efficacytrial is
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Phase: 3 (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Disease area, neurology: Yes (raises risk) · Disease area
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
• Number of arms: 2 (raises risk) · Design
• Minimum age: 15 (raises risk) · Who can join
• Blinding: double (raises risk) · Design
• Collaborators: 0 (raises risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• Efficacy Study of GS010 for Treatment of Vision Loss From 7 Months to 1 Year From Onset in LHON Due to the ND4 Mutation (REVERSE) NCT02652780 · started 2016 · scored riskier than 60% of active trials completed
• Efficacy Study of GS010 for the Treatment of Vision Loss up to 6 Months From Onset in LHON Due to the ND4 Mutation NCT02652767 · started 2016 · scored riskier than 53% of active trials completed
• Safety Study of an Adeno-associated Virus Vector for Gene Therapy of Leber's Hereditary Optic Neuropathy NCT02161380 · started 2014 · scored riskier than 40% of active trials completed
• Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ND1 Mutations NCT05820152 · started 2023 · scored riskier than 32% of active trials terminated
• A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy NCT02693119 · started 2016 · scored riskier than 20% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.