Trial · NCT00596466
Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
NCT00596466, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2012-09-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures. Trials, record NCT00596466. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00596466
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
- NCT number
- NCT00596466
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 75 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Epilepsy
- Interventions
- pregabalin
- First posted
- 2008-01-17
- Last updated
- 2021-01-26
- Results first posted
- 2012-09-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Seizure Frequency | Baseline up to Week 28 | |
| Primary | Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 28 | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Primary | Number of Participants With Laboratory Test Values of Potential Clinical Importance | Baseline up to Week 28 | Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Seizure Frequency | Baseline up to Week 28 | Not analyzed; Per protocol, seizure frequency data for individual participants were collected and reviewed but no statistical inferences were conducted because there was no comparator agent for this study. | ||
| PRIMARY | Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 28 | Safety analysis set population: all participants who received at least 1 dose of pregabalin. | Participants | NUMBER |
| PRIMARY | Number of Participants With Laboratory Test Values of Potential Clinical Importance | Baseline up to Week 28 | Safety analysis set population; Number of participants analyzed (N): participants with at least one observation of any given laboratory test while on study. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Pregabalin | Non-serious AEs | 30 | Participants | |
| Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Pregabalin | Serious AEs (SAEs) | 3 | Participants | |
| Number of Participants With Laboratory Test Values of Potential Clinical Importance | Pregabalin | 17 | Participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin | 75 | |
| Overall Study | Enrolled, Treated | Pregabalin | 73 | |
| Overall Study | COMPLETED | Pregabalin | 58 | |
| Overall Study | NOT COMPLETED | Pregabalin | 17 |
Source ClinicalTrials.gov
Adverse events8
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 | Nausea | Gastrointestinal disorders | Pregabalin | 4 | 73 | |
| other | Weight increased | Investigations | Pregabalin | 3 | 73 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Pregabalin | 3 | 73 | |
| other | Convulsion | Nervous system disorders | Pregabalin | 3 | 73 | |
| other | Headache | Nervous system disorders | Pregabalin | 4 | 73 | |
| serious | Road traffic accident | Injury, poisoning and procedural complications | Pregabalin | 1 | 73 | |
| serious | Convulsion | Nervous system disorders | Pregabalin | 2 | 73 | |
| serious | Transient ischaemic attack | Nervous system disorders | Pregabalin | 1 | 73 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, other adverse events | Pregabalin | 14 | 73 |
| Total, serious adverse events | Pregabalin | 3 | 73 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00596466
GET https://conductscience.org/api/trials/v1/NCT00596466/registered