Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 11% 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 (453 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 2014-07-31, after 2012-02-29 start.
Reason given by the sponsor: “enrollment”
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 2014-07-31. 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) (raises risk) · Wording
Phrases that raised it: patients mustcancerprostateinterferontreatment
Phrases that lowered it: multipletabletshistorymalealcohol -
Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Collaborators: 3 (lowers risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 43.8% (raises risk) · Drug's FDA history
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Phase: 2 (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Disease area, neurology: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Maximum age: 65 (lowers risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (raises risk) · Design
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Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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Number of arms: 2 (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.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 3 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 16 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 43.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, immunology
- Drugs matched to FDA substances
- testosterone undecanoate
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
- Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis NCT03185065 · started 2017 · scored riskier than 59% of active trials completed
- Ketamine for Treatment of MS Fatigue NCT03500289 · started 2018 · scored riskier than 74% of active trials completed
- Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients NCT00965341 · started 2009 · scored riskier than 85% of active trials completed
- Safety and Tolerability of Quetiapine in Multiple Sclerosis NCT02087631 · started 2014 · scored riskier than 66% of active trials completed
- A Phase IIIb, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of EK-12 in Patients With RRMS NCT03283397 · started 2019 · scored riskier than 71% of active trials terminated
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.