Trial · NCT00537238
Pregabalin Versus Levetiracetam In Partial Seizures
NCT00537238, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2013-07-11
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ConductScience Library. Pregabalin Versus Levetiracetam In Partial Seizures. Trials, record NCT00537238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00537238
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregabalin Versus Levetiracetam In Partial Seizures
- NCT number
- NCT00537238
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 509 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Partial Seizures
- Interventions
- pregabalin, levetiracetam
- First posted
- 2007-10-01
- Last updated
- 2021-01-28
- Results first posted
- 2013-07-11
- Limitations and caveats
- Results for BPRS were provided as change in scores at Week 16 compared to baseline instead of absolute scores as per planned analysis.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With Response to Treatment | Baseline up to Week 16 | Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28. |
| Secondary | Percent Change From Baseline in 28 Day Seizure Frequency at Week 16 | Baseline, Week 16 | The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. |
| Secondary | Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16 | Baseline, Week 16 | Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures. |
| Secondary | Percentage of Participants Without Seizures | Baseline up to Week 16 | Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure. |
| Secondary | Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up | Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase) | BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment. |
| Secondary | Hospital Anxiety and Depression Scale (HADS) Score | Baseline, Week 16 | HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. |
| Secondary | Medical Outcomes Study Sleep Scale (MOS-SS) Score | Baseline, Week 16 | Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score\[RS\] minus lowest possible score divided by possible RS range\*100);total score range:0-100;higher score=more intensity of attribute. |
| Secondary | Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score | Baseline, Week 16 | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported. |
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 | Proportion of Participants With Response to Treatment | Baseline up to Week 16 | Per protocol population included all randomized participants who had at least 28 days of study drug during the maintenance phase and a minimum of 28 days of utilizable seizure diary data during baseline and maintenance phases of the study and had no major protocol violation. | proportion of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in 28 Day Seizure Frequency at Week 16 | Baseline, Week 16 | Full analysis set (FAS) included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. | percent change | MEDIAN |
| SECONDARY | Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16 | Baseline, Week 16 | SGTC population included all participants who had at least 1 SGTC seizure during either baseline or double-blind phase. n=number of participants evaluable at specific time points for each arm group, respectively. | percentage of all partial seizure/28days | MEAN |
| SECONDARY | Percentage of Participants Without Seizures | Baseline up to Week 16 | FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up | Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase) | FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Hospital Anxiety and Depression Scale (HADS) Score | Baseline, Week 16 | FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study Sleep Scale (MOS-SS) Score | Baseline, Week 16 | FAS included all randomized participants who had received at least 1 blinded dose of study medication and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score | Baseline, Week 16 | FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With Response to Treatment | Pregabalin | 0.59 | proportion of participants | ||
| Proportion of Participants With Response to Treatment | Levetiracetam | 0.59 | proportion of participants | ||
| Percent Change From Baseline in 28 Day Seizure Frequency at Week 16 | Pregabalin | -53.93 | Full Range -100.0 to 533.1 | percent change | |
| Percent Change From Baseline in 28 Day Seizure Frequency at Week 16 | Levetiracetam | -57.28 | Full Range -100.0 to 276.9 | percent change | |
| Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16 | Pregabalin | Baseline (n=107, 111) | 39.41 | Standard Deviation 38.141 | percentage of all partial seizure/28days |
| Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16 | Levetiracetam | Baseline (n=107, 111) | 38.94 | Standard Deviation 35.870 | percentage of all partial seizure/28days |
| Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16 | Pregabalin | Change at Week 16 (n=102, 101) | 3.93 | Standard Deviation 30.158 | percentage of all partial seizure/28days |
| Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16 | Levetiracetam | Change at Week 16 (n=102, 101) | 6.33 | Standard Deviation 32.071 | percentage of all partial seizure/28days |
| Percentage of Participants Without Seizures | Pregabalin | All Partial Seizure | 19.9 | 95% Confidence Interval 14.4 to 25.4 | percentage of participants |
| Percentage of Participants Without Seizures | Levetiracetam | All Partial Seizure | 27.6 | 95% Confidence Interval 21.6 to 33.7 | percentage of participants |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin | 254 | |
| Overall Study | STARTED | Levetiracetam | 255 | |
| Overall Study | Completed Titration Phase | Pregabalin | 226 | |
| Overall Study | Completed Titration Phase | Levetiracetam | 236 | |
| Overall Study | Completed Maintenance Phase | Pregabalin | 208 | |
| Overall Study | Completed Maintenance Phase | Levetiracetam | 210 | |
| Overall Study | Entered Opt Blinded Continuation Phase | Pregabalin | 185 | |
| Overall Study | Entered Opt Blinded Continuation Phase | Levetiracetam | 195 | |
| Overall Study | COMPLETED | Pregabalin | 80 | |
| Overall Study | COMPLETED | Levetiracetam | 82 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events124
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 | 5 | 254 | |
| other | Nausea | Gastrointestinal disorders | Levetiracetam | 15 | 255 | |
| other | Nasopharyngitis | Infections and infestations | Pregabalin | 24 | 254 | |
| other | Nasopharyngitis | Infections and infestations | Levetiracetam | 19 | 255 | |
| other | Weight increased | Investigations | Pregabalin | 26 | 254 | |
| other | Weight increased | Investigations | Levetiracetam | 8 | 255 | |
| other | Dizziness | Nervous system disorders | Pregabalin | 59 | 254 | |
| other | Dizziness | Nervous system disorders | Levetiracetam | 42 | 255 | |
| other | Headache | Nervous system disorders | Pregabalin | 37 | 254 | |
| other | Headache | Nervous system disorders | Levetiracetam | 30 | 255 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 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 | Levetiracetam | ||
| Total, other adverse events | Pregabalin | 148 | 254 |
| Total, other adverse events | Levetiracetam | 127 | 255 |
| Total, serious adverse events | Pregabalin | 24 | 254 |
| Total, serious adverse events | Levetiracetam | 24 | 255 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24902473 | 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 vs Levetiracetam: 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/NCT00537238
GET https://conductscience.org/api/trials/v1/NCT00537238/results?page=2