Trial · NCT00372528
An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures
NCT00372528, Phase 3, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2012-10-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures. Trials, record NCT00372528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00372528
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures
- NCT number
- NCT00372528
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 21 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Epilepsy
- Interventions
- pregabalin (LYRICA)
- First posted
- 2006-09-07
- Last updated
- 2021-01-26
- Results first posted
- 2012-10-23
- Limitations and caveats
This was a compassionate use study and no formal primary outcome measure was specified a priori. Descriptive safety data were collected, subsequently safety outcome was designated as primary outcome as per National Institute of Health (NIH) criteria.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Year 5 and follow-up (30 days after last dose) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Secondary | Mean Number of Seizures | Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose) | Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Year 5 and follow-up (30 days after last dose) | Safety Analysis Set (SAS) included all participants who had received at least 1 dose of study medication in the open label period. | Participants | NUMBER |
| SECONDARY | Mean Number of Seizures | Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose) | SAS included all participants who had received at least 1 dose of study medication in the open label period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable between each visit. | Seizures | MEAN |
Source ClinicalTrials.gov
Results by group11
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 Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Pregabalin | AEs | 21 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Pregabalin | SAEs | 3 | Participants | |
| Mean Number of Seizures | Pregabalin | Month 6 to Month 12 (n = 20) | 35.10 | Standard Deviation 46.92 | Seizures |
| Mean Number of Seizures | Pregabalin | Month 12 to Month 18 (n = 18) | 29.70 | Standard Deviation 26.05 | Seizures |
| Mean Number of Seizures | Pregabalin | Month 18 to Month 24 (n = 19) | 27.80 | Standard Deviation 28.75 | Seizures |
| Mean Number of Seizures | Pregabalin | Month 24 to Month 30 (n = 18) | 32.50 | Standard Deviation 33.91 | Seizures |
| Mean Number of Seizures | Pregabalin | Month 30 to Month 36 (n = 18) | 29.30 | Standard Deviation 29.13 | Seizures |
| Mean Number of Seizures | Pregabalin | Month 36 to Month 42 (n = 17) | 28.70 | Standard Deviation 28.38 | Seizures |
| Mean Number of Seizures | Pregabalin | Month 42 to Month 48 (n = 11) | 24.80 | Standard Deviation 32.99 | Seizures |
| Mean Number of Seizures | Pregabalin | Month 54 or EOS (n = 19) | 22.90 | Standard Deviation 24.57 | Seizures |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin | 21 | |
| Overall Study | COMPLETED | Pregabalin | 0 | |
| Overall Study | NOT COMPLETED | Pregabalin | 21 |
Source ClinicalTrials.gov
Adverse events82
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 | Thrombocytopenia | Blood and lymphatic system disorders | Pregabalin | 1 | 21 | |
| other | Cyanosis | Cardiac disorders | Pregabalin | 1 | 21 | |
| other | Myocardial infarction | Cardiac disorders | Pregabalin | 1 | 21 | |
| other | Cerumen impaction | Ear and labyrinth disorders | Pregabalin | 1 | 21 | |
| other | Deafness | Ear and labyrinth disorders | Pregabalin | 1 | 21 | |
| other | Tympanic membrane perforation | Ear and labyrinth disorders | Pregabalin | 1 | 21 | |
| other | Visual acuity reduced | Eye disorders | Pregabalin | 1 | 21 | |
| other | Diarrhoea | Gastrointestinal disorders | Pregabalin | 2 | 21 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Pregabalin | 2 | 21 | |
| other | Haematochezia | Gastrointestinal disorders | Pregabalin | 1 | 21 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse 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 | 21 | 21 |
| Total, serious adverse events | Pregabalin | 3 | 21 |
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/NCT00372528
GET https://conductscience.org/api/trials/v1/NCT00372528/events?page=2