Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (276 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 2016-08-31, after 2014-05-31 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 2016-08-31. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: injurytreatment ofheadachetraumaticevidence
Phrases that lowered it: subjects whotreatmentdaydrugdays -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 7.9% (raises risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Design: single group (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 88 (lowers risk) · Sponsor's track record
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Responsible party: principal investigator (lowers risk) · Design
-
Drug's FAERS reports with a death: 0% (raises risk) · Drug's FDA history
-
Maximum age: 60 (lowers risk) · Who can join
-
Sponsor's past trials: 279 (lowers risk) · Sponsor's track record
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
- 3 (typical: 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
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 60 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 279 (typical: 32)
- Sponsor's past termination rate
- 7.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 88 (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
- 1 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- onabotulinumtoxina
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
- OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study NCT01920945 · started 2014 · scored riskier than 33% of active trials terminated
- Efficacy of OnabotulinumtoxinA in Migraine NCT04578782 · started 2018 · scored riskier than 17% of active trials completed
- Amitriptyline to Prevent Headache After Traumatic Brain Injury NCT01856270 · started 2013 · scored riskier than 49% of active trials completed
- Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units? NCT04349176 · started 2017 · scored riskier than 10% of active trials terminated
- A Prospective Controlled Treatment Trial for Post-Traumatic Headaches NCT03007420 · started 2018 · scored riskier than 59% of active trials terminated
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.