Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (389 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 2011-10-31, after 2010-07-31 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 2011-10-31. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Phase: 2 (raises risk) · Design
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Design: single group (raises risk) · Design
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Drug's FAERS reports with a death: 25% (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectwith chroniccancerpatientsbreast
Phrases that lowered it: indexbody massinvestigatorrangealcohol -
Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 5 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 94.4% (raises risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 65 (raises risk) · Who can join
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Sponsor's past trials: 3 (raises risk) · Sponsor's track record
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Blinding: none (raises risk) · Design
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Drug's FAERS reports before start: 36 (lowers risk) · Drug's FDA history
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 8 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (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
- 36 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, neurology, musculoskeletal
- Drugs matched to FDA substances
- droxidopa
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 Assess The Clinical Benefit Of Droxidopa And Droxidopa/Carbidopa In Subjects With Fibromyalgia NCT01323374 · started 2009 · scored riskier than 43% of active trials completed
- Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) NCT00738062 · started 2008 · scored riskier than 24% of active trials completed
- Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304) NCT01132326 · started 2009 · scored riskier than 22% of active trials completed
- A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia NCT03092726 · started 2017 · scored riskier than 60% of active trials completed
- A Study to Assess the Analgesic Efficacy and Safety of ASP0819 in Patients With Fibromyalgia NCT03056690 · started 2017 · scored riskier than 49% 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.