Trial · NCT01389596
A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
NCT01389596, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2017-03-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years. Trials, record NCT01389596. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01389596
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
- NCT number
- NCT01389596
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 295 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Epilepsy, Partial Seizures
- Interventions
- Pregabalin add-on therapy, Pregabalin add-on therapy, Pregabalin add-on therapy
- First posted
- 2011-07-08
- Last updated
- 2021-01-20
- Other registries' IDs
- eudract:2010-020852-79
- Results first posted
- 2017-03-21
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase | Baseline phase (up to 8 weeks prior to treatment phase [Day 1]) | All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the baseline phase\] divided by \[number of days in baseline phase minus {-} number of missing diary days in baseline phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1). |
| Primary | Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase | Day 1 up to Week 12 | All partial onset seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the treatment phase\] divided by \[number of days in treatment phase minus {-} number of missing diary days in treatment phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1). |
| Secondary | Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase | Day 1 up to Week 12 | Percentage of participants with 50 percent (%) or greater reduction from baseline in 28-day seizure rate during the 12 week treatment phase were reported. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the treatment phase\] divided by \[number of days in treatment phase minus {-} number of missing diary days in treatment phase\])\*28. |
| Other | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) | 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 were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre- treatment state. AEs included both serious and non-serious adverse events. |
| Other | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events. |
| Other | Number of Adverse Events by Severity | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function. |
| Other | Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories At Baseline | Baseline (4 week prior to Day 1 of treatment) | The C-SSRS (mapped to C-CASA) is a participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of "Yes" on "actual attempt") (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) ("Yes" on "preparatory acts or behavior")(C-CASA code 3); suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). In this outcome, number of participants with positive response (response of "yes") to C-SSRS (mapped to C-CASA categories 2, 3, 4 and 7) at baseline were reported. |
| Other | Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories During Post Baseline Time Period | Day 1 up to Week 13 | C-SSRS (mapped to C-CASA):participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of "Yes" on "actual attempt") (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) ("Yes" on "preparatory acts or behavior")(C-CASA code 3); suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). Number of participants with positive response (response of "yes") to C-SSRS (mapped to C-CASA categories 1, 2, 3, 4 and 7) during post baseline time period (Day 1 up to Week 13) were reported |
| Other | Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) | CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of \>=68 on the T-scores was used for all 3 subscales. If a participant T Score was \>=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study. |
| Other | Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) | CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of \>=68 on the T-scores was used for all 3 subscales. If a participant T Score was \>=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase | Baseline phase (up to 8 weeks prior to treatment phase [Day 1]) | Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. | Seizures per 28 days | MEAN |
| PRIMARY | Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase | Day 1 up to Week 12 | ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. Here, Number of Participants Analyzed (N) signifies number of participants who were evaluable for this outcome measure. | Seizures per 28 days | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase | Day 1 up to Week 12 | ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) | Safety population included all randomized participants who took at least 1 dose of the study drug. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) | Safety population included all randomized participants who took at least 1 dose of the study drug. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Adverse Events by Severity | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) | Safety population included all randomized participants who took at least 1 dose of the study drug. | events | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories At Baseline | Baseline (4 week prior to Day 1 of treatment) | Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories During Post Baseline Time Period | Day 1 up to Week 13 | Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) | Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively. | T scores | MEAN |
| OTHER_PRE_SPECIFIED | Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) | Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively. | T scores | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group186
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 3.27 | Standard Deviation 1.215 | Seizures per 28 days | |
| Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 3.19 | Standard Deviation 1.269 | Seizures per 28 days | |
| Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase | Placebo | 3.18 | Standard Deviation 1.302 | Seizures per 28 days | |
| Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 2.86 | Standard Error 0.070 | Seizures per 28 days | |
| Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 2.74 | Standard Error 0.072 | Seizures per 28 days | |
| Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase | Placebo | 2.96 | Standard Error 0.073 | Seizures per 28 days | |
| Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 29.1 | percentage of participants | ||
| Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 40.6 | percentage of participants | ||
| Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase | Placebo | 22.6 | percentage of participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | AEs | 67 | participants |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 104 | |
| Overall Study | STARTED | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 97 | |
| Overall Study | STARTED | Placebo | 94 | |
| Overall Study | COMPLETED | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 94 | |
| Overall Study | COMPLETED | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 81 | |
| Overall Study | COMPLETED | Placebo | 84 | |
| Overall Study | NOT COMPLETED | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 10 | |
| Overall Study | NOT COMPLETED | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 10 |
Source ClinicalTrials.gov
Adverse events519
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 | Anaemia | Blood and lymphatic system disorders | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 1 | 104 | |
| other | Anaemia | Blood and lymphatic system disorders | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 0 | 97 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 94 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 0 | 104 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 0 | 97 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Placebo | 1 | 94 | |
| other | Atrioventricular block first degree | Cardiac disorders | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 0 | 104 | |
| other | Atrioventricular block first degree | Cardiac disorders | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 0 | 97 | |
| other | Atrioventricular block first degree | Cardiac disorders | Placebo | 1 | 94 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 2 | 104 |
1 to 10 of 519Source ClinicalTrials.gov
See all 519 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | ||
| Total, all-cause mortality | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 66 | 104 |
| Total, other adverse events | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 64 | 97 |
| Total, other adverse events | Placebo | 55 | 94 |
| Total, serious adverse events | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 5 | 104 |
| Total, serious adverse events | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 10 | 97 |
| Total, serious adverse events | Placebo | 7 | 94 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30688135 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Choice Reaction Time | Other outcome | ConductCognition |
| Go/No-Go Task | Other outcome | ConductCognition |
| Simple Reaction Time | Other outcome | ConductCognition |
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.
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