Trial · NCT00537940
Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures
NCT00537940, Phase 4, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2014-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures. Trials, record NCT00537940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00537940
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures
- NCT number
- NCT00537940
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 482 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Epilepsy, Partial Seizure Disorder, Epilepsies, Partial, Complex Partial Seizure Disorder
- Interventions
- Pregabalin, Gabapentin
- First posted
- 2007-10-02
- Last updated
- 2021-01-22
- Other registries' IDs
- eudract:2007-003161-40
- Results first posted
- 2014-08-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in 28-day Seizure Frequency at Week 21. | 6 weeks Baseline, 21 weeks through End of MP for 27 weeks | 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. Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + secondary generalized tonic clonic seizure \[SGTC\]). |
| Secondary | Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21. | 6 weeks Baseline, 21 weeks through End of MP for 27 weeks | Participants who had at least 50% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 50% responders. If percent change from baseline \<= -50 then responder rate = 1 (yes) otherwise responder rate = 0 (no). |
| Secondary | Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21. | 6 weeks Baseline, 21 weeks through End of MP for 27 weeks | Participants who had at least 75% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 75% responders. If percent change from baseline \<= -75 then 75% responder rate = 1 (yes) otherwise responder rate = 0 (no). Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + SGTC). |
| Secondary | Percentage of Participants Without Seizures. | 6 weeks Baseline, 21 weeks through End of MP for 27 weeks | 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 MP. 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 the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21. | 6 weeks Baseline, 21 weeks through End of MP for 27 weeks | Change in SGTC = (Proportion of SGTC/All Partial Seizure rate during at the double-blind phase) - (Proportion of SGTC/All Partial Seizure rate at Baseline). Negative values indicate reduction from baseline. |
| Secondary | Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21. | 6 weeks Baseline, 21 weeks through End of MP for 27 weeks | SGTC Responder is defined as a participant who shows reduction from Baseline to double-blind phase in proportion of 28-Day SGTC Seizure Rate to 28-Day All Partial Seizure Rate. |
| Secondary | Hospital Anxiety and Depression Scale (HADS) Score. | Baseline, Week 21 | HADS: participant rated questionnaire with 2 subscales. Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (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 21 | 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 21 | 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
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in 28-day Seizure Frequency at Week 21. | 6 weeks Baseline, 21 weeks through End of MP for 27 weeks | 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 | Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21. | 6 weeks Baseline, 21 weeks through End of MP for 27 weeks | 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=is the number of subjects that can be analyzed for each treatment group. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21. | 6 weeks Baseline, 21 weeks through End of MP for 27 weeks | 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=is the number of participants that can be analyzed for each treatment group. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Without Seizures. | 6 weeks Baseline, 21 weeks through End of MP for 27 weeks | 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 the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21. | 6 weeks Baseline, 21 weeks through End of MP for 27 weeks | 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 | Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21. | 6 weeks Baseline, 21 weeks through End of MP for 27 weeks | SGTC population included all participants who had at least 1 SGTC seizure during either Baseline or double-blind phase. n is the number of participants analyzed for SGTC. Twenty-six participants were not included in the n because they did not have a post Baseline all partial seizure, but they were included in the analysis by seizure type. | percentage of responders | NUMBER |
| SECONDARY | Hospital Anxiety and Depression Scale (HADS) Score. | Baseline, Week 21 | 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 21 | 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 | Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score. | Baseline, Week 21 | 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 specifictime points for each arm group, respectively. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in 28-day Seizure Frequency at Week 21. | Pregabalin | -58.65 | Full Range -100.0 to 180.0 | percent change | |
| Percent Change From Baseline in 28-day Seizure Frequency at Week 21. | Gabapentin | -57.43 | Full Range -100.0 to 392.4 | percent change | |
| Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21. | Pregabalin | All Partial Seizure (n=238, 240) | 56.3 | 95% Confidence Interval 50.0 to 62.6 | Percentage of participants |
| Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21. | Gabapentin | All Partial Seizure (n=238, 240) | 58.3 | 95% Confidence Interval 52.1 to 64.6 | Percentage of participants |
| Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21. | Pregabalin | Simple Partial (n=87, 88) | 55.2 | 95% Confidence Interval 44.7 to 65.6 | Percentage of participants |
| Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21. | Gabapentin | Simple Partial (n=87, 88) | 53.4 | 95% Confidence Interval 43.0 to 63.8 | Percentage of participants |
| Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21. | Pregabalin | Complex Partial (n=161, 158) | 56.5 | 95% Confidence Interval 48.9 to 64.2 | Percentage of participants |
| Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21. | Gabapentin | Complex Partial (n=161, 158) | 55.1 | 95% Confidence Interval 47.3 to 62.8 | Percentage of participants |
| Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21. | Pregabalin | SGTC (n=112, 114) | 50.9 | 95% Confidence Interval 41.6 to 60.2 | Percentage of participants |
| Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21. | Gabapentin | SGTC (n=112, 114) | 60.5 | 95% Confidence Interval 51.6 to 69.5 | Percentage of participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 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 | 241 | |
| Overall Study | STARTED | Gabapentin | 241 | |
| Overall Study | Completed Titration Phase | Pregabalin | 213 | |
| Overall Study | Completed Titration Phase | Gabapentin | 210 | |
| Overall Study | Completed Maintenance Phase | Pregabalin | 187 | |
| Overall Study | Completed Maintenance Phase | Gabapentin | 172 | |
| Overall Study | Entered Opt Blinded Continuation Phase | Pregabalin | 140 | |
| Overall Study | Entered Opt Blinded Continuation Phase | Gabapentin | 139 | |
| Overall Study | COMPLETED | Pregabalin | 58 | |
| Overall Study | COMPLETED | Gabapentin | 62 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events90
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 | Dry mouth | Gastrointestinal disorders | Pregabalin | 12 | 241 | |
| other | Dry mouth | Gastrointestinal disorders | Gabapentin | 8 | 241 | |
| other | Weight increased | Investigations | Pregabalin | 23 | 241 | |
| other | Weight increased | Investigations | Gabapentin | 15 | 241 | |
| other | Dizziness | Nervous system disorders | Pregabalin | 22 | 241 | |
| other | Dizziness | Nervous system disorders | Gabapentin | 21 | 241 | |
| other | Headache | Nervous system disorders | Pregabalin | 21 | 241 | |
| other | Headache | Nervous system disorders | Gabapentin | 25 | 241 | |
| other | Somnolence | Nervous system disorders | Pregabalin | 35 | 241 | |
| other | Somnolence | Nervous system disorders | Gabapentin | 34 | 241 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 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 | Gabapentin | ||
| Total, other adverse events | Pregabalin | 77 | 241 |
| Total, other adverse events | Gabapentin | 77 | 241 |
| Total, serious adverse events | Pregabalin | 13 | 241 |
| Total, serious adverse events | Gabapentin | 14 | 241 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27521437 | 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 Gabapentin: 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/NCT00537940
GET https://conductscience.org/api/trials/v1/NCT00537940/results?page=2