Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica)
Model scores of the 29,894 trials active now.
Model score 7% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (201 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-07-31, after 2015-11-30 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2017-07-31. 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.
What moved the score
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: painpriortherapytypedays
Phrases that lowered it: subjectscrossoversinglescreeninglaboratory -
Design: crossover (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 10.7% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 58.3% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 9.5% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 71 (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Maximum age: 70 (raises risk) · Who can join
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.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 215 (typical: 32)
- Sponsor's past termination rate
- 10.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 71 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 27382 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4877 (typical: 412.5)
- Drug's FAERS reports marked serious
- 58.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- lidocaine
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Phase 2 Efficacy Trial of Z160 in Lumbosacral Radiculopathy NCT01655849 · started 2012 · scored riskier than 46% of active trials completed
- Phase I Study to Investigate Safety, Tolerability, and Pharmacokinetics of VVZ-149 Injection NCT01905410 · started 2013 · scored riskier than 2% of active trials completed
- Crossover Study of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy NCT01561027 · started 2011 · scored riskier than 38% of active trials completed
- Efficacy, Safety, and Pharmacokinetics of Femoral Nerve Block With EXPAREL in Total Knee Arthroplasty NCT02713178 · started 2016 · scored riskier than 22% of active trials completed
- Phase 1, Dose Escalation Study to Evaluate of Safety, Pharmacokinetics and Pharmacodynamics of Liposomal Bupivacaine 13.3 Administered Via a Single Intrathecal Injection to Healthy Volunteers NCT05456490 · started 2023 · scored riskier than 11% 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.