Safety and Efficacy Study of SOM230 s.c. in Cluster Headache
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 1% 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 2018-09-25, after 2016-10-31 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 2018-09-25. 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: 14.4% (raises risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: effectiveacutepriorpatientwomen of
Phrases that lowered it: single dosesubjectsmalesubjectday -
Sponsor's past trials: 940 (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 7.6% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 188 (lowers risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Blinding: double (raises risk) · Design
-
Disease area, respiratory: Yes (raises risk) · Disease area
-
Drug's FAERS reports marked serious: 76.2% (lowers risk) · Drug's FDA history
-
Number of arms: 2 (raises risk) · Design
-
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
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (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
- 940 (typical: 32)
- Sponsor's past termination rate
- 14.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 188 (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
- 630 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 253 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, respiratory, immunology
- Drugs matched to FDA substances
- pasireotide
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
- Prevention Study in Adult Patients Suffering From Migraine Headaches NCT00742209 · started 2008 · scored riskier than 18% of active trials completed
- Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents NCT00963937 · started 2009 · scored riskier than 11% of active trials completed
- Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches NCT04066023 · started 2019 · scored riskier than 24% of active trials completed
- Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine NCT01820559 · started 2009 · scored riskier than 9% of active trials completed
- Cluster Headache Treatment With Rimegepant NCT05264714 · started 2022 · scored riskier than 88% 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.