Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3
Model scores of the 29,894 trials active now.
Model score 21% 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 19% of the time (731 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-09-13, after 2019-03-07 start.
Reason given by the sponsor: “other”
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 2021-09-13. 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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Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: the patientterm safetylong termprotocolthe opinion
Phrases that lowered it: typesafetyproductsparticipate inof drug -
Phase: 2 (raises risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 32.3% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: none (raises risk) · Design
-
Sponsor's past trials: 6 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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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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Minimum age: 6 (raises risk) · Who can join
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Collaborators: 0 (raises risk) · Design
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Responsible party: sponsor (lowers 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
- 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
- 1
Who can join
- Minimum age
- 6 (typical: 18)
- Maximum age
- 50 (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
- 6 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 31 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 19 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 32.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- amifampridine
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
- Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients NCT03781479 · started 2019 · scored riskier than 21% of active trials completed
- Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis) NCT03579966 · started 2018 · scored riskier than 79% of active trials terminated
- Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Years SMA Patients. NCT01302600 · started 2010 · scored riskier than 57% of active trials completed
- Amifampridine Phosphate for the Treatment of Congenital Myasthenic Syndromes NCT02562066 · started 2016 · scored riskier than 15% of active trials completed
- An Open Label Study of LMI070 (Branaplam) in Type 1 Spinal Muscular Atrophy (SMA) NCT02268552 · started 2015 · scored riskier than 92% 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.