Trial · NCT00280059
Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
NCT00280059, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-10-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy. Trials, record NCT00280059. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00280059
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
- NCT number
- NCT00280059
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 660 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Epilepsy, Partial
- Interventions
- Pregabalin, Lamotrigine
- First posted
- 2006-01-20
- Last updated
- 2021-01-28
- Results first posted
- 2011-10-24
- Limitations and caveats
Cox proportional hazards model for time to event (TTE) analyses; three summary statistics were not generated as median TTE will not exist if survival function (Kaplan-Meier product limit estimates) does not fall below 0.5 (post-hoc analysis).
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase | Week 5 up to Week 56 | Responders = participants who achieved any 6 consecutive months (\>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase. |
| Secondary | Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures | Week 4 up to Week 56 | Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis. |
| Secondary | Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase) | Week 0 to Week 56 | Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication. |
| Secondary | Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase) | Week 0 to Week 56 | Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication. |
| Secondary | Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase | Week 4 up to Week 56 | Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication. |
| Secondary | Exit Due to Any Reason After 4-week Dose Escalation Phase | Week 4 up to Week 56 | Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication. |
| Secondary | Time to First Seizure After the 4-Week Dose Escalation Phase | Week 4 up to Week 56 | Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication. |
| Secondary | Median Monthy Seizure Frequency: All Partial Seizures | Baseline up to Week 60 | All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \* 28. Month of time = number of months after Week 4 (Dose Escalation). |
| Secondary | Mean Monthy Seizure Frequency: All Partial Seizures | Baseline up to Week 60 | All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \* 28. Month of time = number of months after Week 4 (Dose Escalation). |
| Secondary | Median Monthy Seizure Frequency: All Seizures | Baseline up to Week 60 | Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \* 28. Month of time = number of months after Week 4 (Dose Escalation). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase | Week 5 up to Week 56 | Full analysis set (FAS) (intent to treat population): randomized participants who took at least 1 dose of study medication. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data. Analysis excludes participants who did not enter maintenance phase of study. | percentage of participants | NUMBER |
| SECONDARY | Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures | Week 4 up to Week 56 | FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. | days | MEDIAN |
| SECONDARY | Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase) | Week 0 to Week 56 | FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to adverse events was inestimable as survival estimate at end of maintenance phase was below 0.500. | participants | NUMBER |
| SECONDARY | Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase) | Week 0 to Week 56 | FAS. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data Time to exit for any reason during the double-blind treatment phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500. | participants | NUMBER |
| SECONDARY | Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase | Week 4 up to Week 56 | FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to lack of efficacy after 4-week dose escalation phase was inestimable as survival estimate at end of maintenance phase was below 0.500. | participants | NUMBER |
| SECONDARY | Exit Due to Any Reason After 4-week Dose Escalation Phase | Week 4 up to Week 56 | FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit for any reason after the 4-week dose escalation phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500. | participants | NUMBER |
| SECONDARY | Time to First Seizure After the 4-Week Dose Escalation Phase | Week 4 up to Week 56 | FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. | days | MEDIAN |
| SECONDARY | Median Monthy Seizure Frequency: All Partial Seizures | Baseline up to Week 60 | FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation. | seizures/28 days | MEDIAN |
| SECONDARY | Mean Monthy Seizure Frequency: All Partial Seizures | Baseline up to Week 60 | FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation. | seizures/28 days | MEAN |
| SECONDARY | Median Monthy Seizure Frequency: All Seizures | Baseline up to Week 60 | FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation. | seizures/28 days | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group230
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase | Pregabalin | 51.6 | percentage of participants | ||
| Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase | Lamotrigine | 67.9 | percentage of participants | ||
| Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures | Pregabalin | 254 | 95% Confidence Interval 199 to 295 | days | |
| Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures | Lamotrigine | 183 | 95% Confidence Interval 183 to 209 | days | |
| Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase) | Pregabalin | 33 | participants | ||
| Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase) | Lamotrigine | 31 | participants | ||
| Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase) | Pregabalin | 94 | participants | ||
| Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase) | Lamotrigine | 80 | participants | ||
| Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase | Pregabalin | 78 | participants | ||
| Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase | Lamotrigine | 58 | participants |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Efficacy Assessment Phase | STARTED | Pregabalin | 330 | |
| Efficacy Assessment Phase | STARTED | Lamotrigine | 330 | |
| Efficacy Assessment Phase | COMPLETED | Pregabalin | 236 | |
| Efficacy Assessment Phase | COMPLETED | Lamotrigine | 250 | |
| Efficacy Assessment Phase | NOT COMPLETED | Pregabalin | 94 | |
| Efficacy Assessment Phase | NOT COMPLETED | Lamotrigine | 80 | |
| Extension Phase | STARTED | Pregabalin | 194 | |
| Extension Phase | STARTED | Lamotrigine | 215 | |
| Extension Phase | COMPLETED | Pregabalin | 145 | |
| Extension Phase | COMPLETED | Lamotrigine | 177 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events242
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 | 7 | 330 | |
| other | Vision blurred | Eye disorders | Lamotrigine | 2 | 330 | |
| other | Abdominal pain | Gastrointestinal disorders | Pregabalin | 4 | 330 | |
| other | Abdominal pain | Gastrointestinal disorders | Lamotrigine | 9 | 330 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Pregabalin | 12 | 330 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Lamotrigine | 17 | 330 | |
| other | Constipation | Gastrointestinal disorders | Pregabalin | 9 | 330 | |
| other | Constipation | Gastrointestinal disorders | Lamotrigine | 5 | 330 | |
| other | Diarrhoea | Gastrointestinal disorders | Pregabalin | 12 | 330 | |
| other | Diarrhoea | Gastrointestinal disorders | Lamotrigine | 13 | 330 |
1 to 10 of 242Source ClinicalTrials.gov
See all 242 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, all-cause mortality | Lamotrigine | ||
| Total, other adverse events | Pregabalin | 186 | 330 |
| Total, other adverse events | Lamotrigine | 171 | 330 |
| Total, serious adverse events | Pregabalin | 44 | 330 |
| Total, serious adverse events | Lamotrigine | 32 | 330 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21889410 | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pregabalin vs Lamotrigine: Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase) | Trial comparisons |
| Pregabalin vs Lamotrigine: Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase) | Trial comparisons |
| Pregabalin vs Lamotrigine: Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase | Trial comparisons |
| Pregabalin vs Lamotrigine: Exit Due to Any Reason After 4-week Dose Escalation Phase | Trial comparisons |
| Pregabalin vs Lamotrigine: serious adverse events | 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/NCT00280059
GET https://conductscience.org/api/trials/v1/NCT00280059/results?page=2