Trial · NCT00524030
Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
NCT00524030, Phase 3, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2012-05-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures. Trials, record NCT00524030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00524030
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
- NCT number
- NCT00524030
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 161 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Epilepsies, Partial
- Interventions
- pregabalin 600 mg/day, pregabalin 150 mg/day
- First posted
- 2007-09-03
- Last updated
- 2021-01-20
- Results first posted
- 2012-05-10
- Limitations and caveats
- External Data Monitoring Committee (DMC) determined study met criteria to stop early for positive efficacy. Exit rate was the basis for primary analysis and is what is reported here.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria | Week 2 up to Week 18 | Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (\>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP \>2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier \[KM\] product limit estimate for survival function) \* 100% |
| Secondary | Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria | Week 2 up to Week 18 | Participants who discontinued due to: episode of SE; SGTC seizure if none within 2 years of study entry; 28-day study seizure rate during DBP \>2 times Max 28-day study seizure rate during BLP; 2-day study seizure rate during DBP \>2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate, defined as (1-KM product limit estimate for survival function) \* 100% |
| Secondary | Percentage of Participants Completing 20 Weeks of Double-Blind Treatment | Randomization up to Week 20 | |
| Secondary | Percentage of Participants Who Met Protocol-Specified Exit Events | Week 2 up to Week 18 | Percentage of participants experiencing any of the following (could have had more than 1): 1) episode of SE; 2) SGTC seizure if none had been experienced within 2 years of study entry; 3) 28-day study seizure rate during DBP \>2 times the Max 28-day study seizure rate during BLP; 4) 2-day study seizure rate during the DBP \>2 times the Max 2-day study seizure rate during BLP; or 5) unacceptable clinically significant increase in frequency/intensity of seizure activity |
| Secondary | Mean Time on Pregabalin Monotherapy | Week 2 to Week 20 | |
| Secondary | Percentage of Seizure-Free Participants by Study Phase | Day 1 up to Day 140 | Percentage of participants who were seizure-free during the last 28 days on double-blind study medication (monotherapy phase, Days 112-140), during the monotherapy portion of the double-blind treatment phase (Days 56-140), and during all of the double-blind treatment phase (Days 1-140) |
| Secondary | Pregabalin Population Pharmacokinetics (PK) | Baseline up to 20 weeks | Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. |
| Secondary | Pregabalin Exposure-Response Analysis | Day 126 | Percentage of participants predicted to exit the study due to any seizure exit criteria at Day 126. The exit rate at Day 126 was predicted using the final model (log normal distribution with respect to treatment group) and the parameter estimates. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria | Week 2 up to Week 18 | Modified Intent to Treat (MITT) Efficacy Set: The first 125 participants randomized who received at least 1 dose of pregabalin in DB treatment phase, had BL seizure assessment, and participated in DB efficacy assessment after Week 2. Number of participants analyzed (N)= number of MITT participants with discontinuation/completion data. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria | Week 2 up to Week 18 | MITT Full Study Set: all randomized participants who met the MITT definition (received at least 1 dose of pregabalin in DB treatment phase, had BL seizure assessment, and participated in DB efficacy assessment after Week 2) | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Completing 20 Weeks of Double-Blind Treatment | Randomization up to Week 20 | MITT Full Study Set | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Met Protocol-Specified Exit Events | Week 2 up to Week 18 | MITT Efficacy Set | Percentage of Participants | NUMBER |
| SECONDARY | Mean Time on Pregabalin Monotherapy | Week 2 to Week 20 | MITT Full Study Set; N=number of participants entering Monotherapy Period | Days | MEAN |
| SECONDARY | Percentage of Seizure-Free Participants by Study Phase | Day 1 up to Day 140 | MITT Full Study Set | Percentage of Participants | NUMBER |
| SECONDARY | Pregabalin Population Pharmacokinetics (PK) | Baseline up to 20 weeks | Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. | ||
| SECONDARY | Pregabalin Exposure-Response Analysis | Day 126 | MITT Full Study Set | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria | Pregabalin 600 mg/Day | 31.9 | 95% Confidence Interval 20.7 to 43.1 | Percentage of Participants | |
| Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria | Pregabalin 150 mg/Day | 37.7 | 95% Confidence Interval 15.4 to 60 | Percentage of Participants | |
| Percentage of Participants Completing 20 Weeks of Double-Blind Treatment | Pregabalin 150 mg/Day | 53.6 | Percentage of Participants | ||
| Percentage of Participants Completing 20 Weeks of Double-Blind Treatment | Pregabalin 600 mg/Day | 58.3 | Percentage of Participants | ||
| Percentage of Participants Who Met Protocol-Specified Exit Events | Pregabalin 150 mg/Day | Status Epilepticus | 0 | Percentage of Participants | |
| Percentage of Participants Who Met Protocol-Specified Exit Events | Pregabalin 600 mg/Day | Status Epilepticus | 1.0 | Percentage of Participants | |
| Percentage of Participants Who Met Protocol-Specified Exit Events | Pregabalin 150 mg/Day | SGTC Seizure (not experienced in previous 2 years) | 0 | Percentage of Participants | |
| Percentage of Participants Who Met Protocol-Specified Exit Events | Pregabalin 600 mg/Day | SGTC Seizure (not experienced in previous 2 years) | 2.9 | Percentage of Participants | |
| Percentage of Participants Who Met Protocol-Specified Exit Events | Pregabalin 150 mg/Day | 28-Day Seizure Rate >2 times Max Baseline Rate | 13.0 | Percentage of Participants | |
| Percentage of Participants Who Met Protocol-Specified Exit Events | Pregabalin 600 mg/Day | 28-Day Seizure Rate >2 times Max Baseline Rate | 10.8 | Percentage of Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin 150 mg/Day | 32 | |
| Overall Study | STARTED | Pregabalin 600 mg/Day | 129 | |
| Overall Study | Completed Double-Blind Treatment Phase | Pregabalin 150 mg/Day | 15 | |
| Overall Study | Completed Double-Blind Treatment Phase | Pregabalin 600 mg/Day | 70 | |
| Overall Study | Completed Taper/Titration Phase | Pregabalin 150 mg/Day | 15 | |
| Overall Study | Completed Taper/Titration Phase | Pregabalin 600 mg/Day | 70 | |
| Overall Study | COMPLETED | Pregabalin 150 mg/Day | 15 | |
| Overall Study | COMPLETED | Pregabalin 600 mg/Day | 70 | |
| Overall Study | NOT COMPLETED | Pregabalin 150 mg/Day | 17 | |
| Overall Study | NOT COMPLETED | Pregabalin 600 mg/Day | 59 |
Source ClinicalTrials.gov
Adverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vision blurred | Eye disorders | Pregabalin 150 mg/Day | 1 | 32 | |
| other | Vision blurred | Eye disorders | Pregabalin 600 mg/Day | 8 | 129 | |
| other | Dry mouth | Gastrointestinal disorders | Pregabalin 150 mg/Day | 2 | 32 | |
| other | Dry mouth | Gastrointestinal disorders | Pregabalin 600 mg/Day | 2 | 129 | |
| other | Flatulence | Gastrointestinal disorders | Pregabalin 150 mg/Day | 0 | 32 | |
| other | Flatulence | Gastrointestinal disorders | Pregabalin 600 mg/Day | 8 | 129 | |
| other | Fatigue | General disorders | Pregabalin 150 mg/Day | 2 | 32 | |
| other | Fatigue | General disorders | Pregabalin 600 mg/Day | 20 | 129 | |
| other | Oedema peripheral | General disorders | Pregabalin 150 mg/Day | 1 | 32 | |
| other | Oedema peripheral | General disorders | Pregabalin 600 mg/Day | 8 | 129 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin 150 mg/Day | ||
| Total, all-cause mortality | Pregabalin 600 mg/Day | ||
| Total, other adverse events | Pregabalin 150 mg/Day | 15 | 32 |
| Total, other adverse events | Pregabalin 600 mg/Day | 75 | 129 |
| Total, serious adverse events | Pregabalin 150 mg/Day | 1 | 32 |
| Total, serious adverse events | Pregabalin 600 mg/Day | 17 | 129 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24415567 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pregabalin 150 mg/Day vs Pregabalin 600 mg/Day: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00524030
GET https://conductscience.org/api/trials/v1/NCT00524030/results?page=2