Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 6% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-10-11, after 2018-01-22 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 2024-10-11. 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: patientsbrainpatientsurgerymri
Phrases that lowered it: healthybodysubjectsvolunteerseffect -
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Minimum age: 21 (lowers risk) · Who can join
-
Drug's FAERS reports marked serious: 37.7% (lowers risk) · Drug's FDA history
-
Disease area, neurology: Yes (raises risk) · Disease area
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Responsible party: sponsor investigator (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 1.4% (lowers risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Phase: 2/3 (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: basic science (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 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
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (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
- 41683 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5570 (typical: 412.5)
- Drug's FAERS reports marked serious
- 37.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, respiratory
- Drugs matched to FDA substances
- oxybate
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
- Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response NCT01961297 · started 2012 · scored riskier than 32% of active trials completed
- Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia NCT03805152 · started 2019 · scored riskier than 5% of active trials completed
- Efficacy of Levetiracetam in Oromandibular and Cranial Dystonia NCT02199509 · started 2014 · scored riskier than 17% of active trials completed
- Neubotulinum Toxin Injection in Cerivical Dystonia NCT04582929 · started 2019 · scored riskier than 2% of active trials completed
- Safety and Efficacy Study of Botox in the Treatment of Forward Head Posture With Associated Episodic Headache Disorder NCT01350375 · started 2009 · scored riskier than 6% 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.