Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Model scores of the 29,894 trials active now.
Model score 11% 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 19% of the time (731 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 2012-08-31, after 2011-04-30 start.
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 2012-08-31. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: scaleratingpatientsrandomizationimpairment
Phrases that lowered it: safety tolerabilityevaluatepharmacokineticsthe safetydaily -
Drug's FAERS reports marked serious: 34.6% (lowers risk) · Drug's FDA history
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Sponsor's past termination rate: 4.8% (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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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Drug's FAERS reports with a death: 1.5% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 33 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 63 (lowers 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
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 11 (typical: 1)
Who can join
- Minimum age
- 13 (typical: 18)
- Maximum age
- 17 (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
- 63 (typical: 32)
- Sponsor's past termination rate
- 4.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 33 (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
- 1549 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 761 (typical: 412.5)
- Drug's FAERS reports marked serious
- 34.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, musculoskeletal
- Drugs matched to FDA substances
- milnacipran
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
- Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia NCT01331109 · started 2011 · scored riskier than 36% of active trials terminated
- Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population NCT01418651 · started 2011 · scored riskier than 15% of active trials terminated
- Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients NCT01294059 · started 2009 · scored riskier than 16% of active trials completed
- Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia NCT00797797 · started 2008 · scored riskier than 14% of active trials completed
- A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome NCT01237587 · started 2011 · scored riskier than 28% 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.