Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 11% 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
Completed on 2012-12-31, after 2012-03-31 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 2012-12-31. 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) (raises risk) · Wording
Phrases that raised it: painophthalmicthe subjectcellfibromyalgia
Phrases that lowered it: asthmarhinitisallergicperiodfood -
Sponsor's past termination rate: 10.8% (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 33.4% (lowers risk) · Drug's FDA history
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Disease area, neurology: Yes (raises risk) · Disease area
-
Blinding: triple (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 2.6% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 47 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: basic science (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: 65 (lowers risk) · Who can join
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (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
- academic or other
- Sponsor's past trials
- 120 (typical: 32)
- Sponsor's past termination rate
- 10.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 47 (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
- 533 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 137 (typical: 412.5)
- Drug's FAERS reports marked serious
- 33.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, musculoskeletal
- Drugs matched to FDA substances
- ketotifen
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
- A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia NCT03092726 · started 2017 · scored riskier than 60% of active trials completed
- A Study to Assess the Analgesic Efficacy and Safety of ASP0819 in Patients With Fibromyalgia NCT03056690 · started 2017 · scored riskier than 49% of active trials completed
- A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia NCT03965091 · started 2019 · scored riskier than 41% of active trials terminated
- Efficacy and Safety of Eslicarbazepine Acetate as Therapy in Subjects With Fibromyalgia NCT01820585 · started 2009 · scored riskier than 10% of active trials completed
- Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients NCT01294059 · started 2009 · scored riskier than 16% 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.