Pilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia
Model scores of the 29,894 trials active now.
Model score 26% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (112 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2010-05-31, after 2009-05-31 start.
Reason given by the sponsor: “safety”
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2010-05-31. 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) (raises risk) · Wording
Phrases that raised it: patients mustcellpatientdefinedto determine
Phrases that lowered it: resultsthe studyusedaysrelevant -
Sponsor's past termination rate: 26.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Phase: 2/3 (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: 80 (lowers risk) · Who can join
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Disease area, neurology: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Collaborators: 2 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 20 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 2.9% (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Disease area, metabolic: Yes (lowers risk) · Disease area
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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 80 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 15 (typical: 32)
- Sponsor's past termination rate
- 26.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 20 (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
- 10145 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4354 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, metabolic
- Drugs matched to FDA substances
- varenicline
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
- Study to Determine the Safety and Tolerability of Varenicline (Chantix®) in Treating Spinocerebellar Ataxia Type 3 NCT00992771 · started 2009 · scored riskier than 64% of active trials completed
- FRDA Investigator Initiated Study (IIS) With Elamipretide NCT05168774 · started 2022 · scored riskier than 67% of active trials completed
- ANAVEX2-73 for Treatment of Early Alzheimer's Disease NCT03790709 · started 2018 · scored riskier than 23% of active trials completed
- A Study to Assess the Efficacy and Safety of Vatiquinone for the Treatment of Participants With Friedreich Ataxia NCT04577352 · started 2020 · scored riskier than 52% of active trials completed
- Varenicline for Gait and Balance Impairment in Parkinson Disease NCT01341080 · started 2010 · scored riskier than 78% 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.