Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
Model scores of the 29,894 trials active now.
Model score 9% 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 8% of the time (544 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-12-23, after 2019-09-26 start.
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 2019-12-23. 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) (lowers risk) · Wording
Phrases that raised it: multiplesafety tolerabilitytypeneuropathyintervention
Phrases that lowered it: interactionpharmacokineticscreeningsingle doseopen label -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 10.6% (raises risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Drug's FAERS reports marked serious: 14.5% (lowers risk) · Drug's FDA history
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 0.6% (lowers risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 37 (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor's past trials: 330 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports in the prior 12 months: 17357 (lowers risk) · Drug's FDA history
-
Blinding: none (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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 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
- 330 (typical: 32)
- Sponsor's past termination rate
- 10.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 37 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 19153 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17357 (typical: 412.5)
- Drug's FAERS reports marked serious
- 14.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- erenumab, galcanezumab, ubrogepant
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
- Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine NCT02828020 · started 2016 · scored riskier than 74% of active trials completed
- Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine NCT02867709 · started 2016 · scored riskier than 77% of active trials completed
- Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants NCT04492020 · started 2020 · scored riskier than 37% of active trials completed
- Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine NCT04818515 · started 2021 · scored riskier than 68% of active trials completed
- A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine NCT06578585 · started 2024 · scored riskier than 14% 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.