Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
Model scores of the 29,894 trials active now.
Model score 12% 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 10% of the time (1,463 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 2011-05-31, after 2008-12-31 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 2011-05-31. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: pregabalinin subjectspurposesubjects withtreating
Phrases that lowered it: investigate theto investigateefficacy andthe efficacyclinical -
Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor's past termination rate: 8.3% (raises risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 4.4% (lowers risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 59 (lowers risk) · Sponsor's track record
-
Number of arms: 6 (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 91.5% (raises risk) · Drug's FDA history
-
Maximum age: not given (lowers risk) · Who can join
-
Sponsor's past trials: 192 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports before start: 11994 (raises risk) · Drug's FDA history
-
Keywords listed: 1 (raises 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
- 3 (typical: 2)
- Number of arms
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 192 (typical: 32)
- Sponsor's past termination rate
- 8.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 59 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 11994 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3737 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- pramipexole, pregabalin
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
- Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients NCT00676403 · started 2008 · scored riskier than 26% of active trials completed
- Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance NCT00991276 · started 2009 · scored riskier than 16% of active trials completed
- RCT for Pregabalin in Restless Legs Syndrome in South Korea NCT04161027 · started 2020 · scored riskier than 11% of active trials completed
- Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS) NCT01521663 · started 2011 · scored riskier than 17% of active trials completed
- A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause NCT03728933 · started 2018 · scored riskier than 20% 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.