Trial · NCT00922987
Clinical Study With Lyrica In Patients Suffering From Epilepsy
NCT00922987, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-06-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Study With Lyrica In Patients Suffering From Epilepsy. Trials, record NCT00922987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00922987
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study With Lyrica In Patients Suffering From Epilepsy
- NCT number
- NCT00922987
- Status
- Completed
- Enrollment
- 286 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Neuralgia, Epilepsy
- Interventions
- Lyrica (pregabalin)
- First posted
- 2009-06-18
- Last updated
- 2021-01-25
- Results first posted
- 2011-06-21
- Limitations and caveats
On review of blinded data it was decided that an additional analysis set, MFAS was required. MFAS was created for analysis of seizure data. The outcomes related to seizure data were therefore analyzed for MFAS population and not FAS population.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency | Baseline through week 16 or early termination (ET) | Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency \* 100, divided by the partial seizure frequency at the baseline visit. |
| Secondary | Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit | Baseline and week 16 or ET | The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant's final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit \* 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency\*100 divided by partial seizure frequency at baseline visit. |
| Secondary | Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study | Week 4 through week 16 or ET | Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study. |
| Secondary | Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit | Baseline, week 4 and week 16 or ET | VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety). |
| Secondary | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Baseline | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. |
| Secondary | Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit | Week 16 or ET | The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C). At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse. |
| Secondary | Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET | Baseline and week 16 or ET | MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute. |
| Other | Number of Participants With Concomitant Drug Treatments | Baseline through Week 16 or ET | Concomitant drug (any drug other than, and in addition to, the study drug) taken for any period of time during the study. |
| Other | Number of Participants With Concomitant Co-morbidities | Baseline through week 16 or ET | Participants who had a concomitant co-morbidity during the study for any period of time from baseline through to Week 16 (Final Visit); participants with more than one concomitant co-morbidity were counted for each of the co-morbidity classes applicable. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency | Baseline through week 16 or early termination (ET) | The modified full analysis set (MFAS) included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit | Baseline and week 16 or ET | MFAS included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis. Analysis was done using last observation carried forward (LOCF) method. | percent change | MEDIAN |
| SECONDARY | Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study | Week 4 through week 16 or ET | MFAS: Data collected during the titration phase, i.e. prior to Visit 2 (Week 4) were not analyzed for this endpoint. Only participants who did not discontinue in the first 4 weeks after the baseline visit (titration phase) and had at least 4 weeks of seizure data during the maintenance phase were analyzed for this endpoint. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit | Baseline, week 4 and week 16 or ET | Full Analysis Set (FAS): Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing. Analysis was done using LOCF method. | millimeter (mm) | MEAN |
| SECONDARY | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Baseline | FAS: Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing. | participants | NUMBER |
| SECONDARY | Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit | Week 16 or ET | FAS: Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET | Baseline and week 16 or ET | The FAS included all participants who received at least 1 dose of the study drug and had at least one efficacy measurement. | Units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Concomitant Drug Treatments | Baseline through Week 16 or ET | Safety analysis set included all enrolled participants who received 1 dose of study medication. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Concomitant Co-morbidities | Baseline through week 16 or ET | Safety analysis set included all enrolled participants who received 1 dose of study medication. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group181
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency | Pregabalin | 85.00 | 95% Confidence Interval 80.66 to 89.34 | Percentage of participants | |
| Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit | Pregabalin | -100.00 | 95% Confidence Interval -100.00 to -87.93 | percent change | |
| Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study | Pregabalin | 172 | Participants | ||
| Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit | Pregabalin | Baseline | 54.12 | 95% Confidence Interval 51.32 to 56.92 | millimeter (mm) |
| Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit | Pregabalin | Change at Week 4 | -13.60 | 95% Confidence Interval -15.37 to -11.84 | millimeter (mm) |
| Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit | Pregabalin | Change at Week 16 or ET | -26.16 | 95% Confidence Interval -28.73 to -23.59 | millimeter (mm) |
| Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Pregabalin | Not Assessed | 0 | participants | |
| Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Pregabalin | Normal, not at all ill | 17 | participants | |
| Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Pregabalin | Borderline ill | 25 | participants | |
| Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Pregabalin | Mildly ill | 64 | participants |
1 to 10 of 181Source ClinicalTrials.gov
See all 181 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 | 281 | |
| Overall Study | COMPLETED | Pregabalin | 277 | |
| Overall Study | NOT COMPLETED | Pregabalin | 4 |
Source ClinicalTrials.gov
Adverse events3
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 | Weight increased | Investigations | Pregabalin | 4 | 281 | 4 |
| other | Somnolence | Nervous system disorders | Pregabalin | 1 | 281 | 1 |
| serious | Dermatitis allergic | Skin and subcutaneous tissue disorders | Pregabalin | 1 | 281 | 1 |
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 | 4 | 281 |
| Total, serious adverse events | Pregabalin | 1 | 281 |
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/NCT00922987
GET https://conductscience.org/api/trials/v1/NCT00922987/results?page=2