Trial · NCT02072824
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
NCT02072824, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2018-10-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures. Trials, record NCT02072824. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02072824
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
- NCT number
- NCT02072824
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 175 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Partial Onset Seizures
- Interventions
- Pregabalin Dose Level 1, Pregabalin Dose Level 2, Placebo
- First posted
- 2014-02-27
- Last updated
- 2021-01-20
- Other registries' IDs
- eudract:2013-003420-37
- Results first posted
- 2018-10-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Day 1 up to Day 14 | All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = (\[Number of seizures in double blind 48 to 72 hour EEG assessment\] divided by \[number of hours of video-EEG monitoring\])\*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1). |
| Secondary | Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Day 1 up to Day 14 | Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = (\[Number of seizures in double blind 48 to 72 hour EEG assessment\] divided by \[number of hours of video-EEG monitoring\])\*24. The EEG assessment was done at the end of the fixed dose treatment. |
| Other | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to End of study (EOS) (maximum Day 25) | 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 AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) 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-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to EOS (maximum Day 25) | 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 AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) 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 EOS (maximum Day 25) | 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 With Laboratory Test Abnormalities | From Baseline up to EOS (maximum Day 25) | Abnormality Criteria: hemoglobin,hematocrit,red blood cells(RBC)count:\<0.8\*lower limit of normal\[LLN\],platelets:\<0.5\*LLN/\>1.75\*upper limit of normal\[ULN\]; leukocytes:\<0.6\*LLN/\>1.5\*ULN; lymphocytes,neutrophils, total protein,albumin, tetraiodothyronine,thyroid stimulating hormone:\<0.8\*LLN/\>1.2\*ULN; basophils,eosinophils,monocytes:\>1.2\*ULN; prothrombin \[PT\],PT international ratio:\>1.1\*ULN; aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase,gamma glutamyl transferase:\>0.3\*ULN; bilirubin:\>1.5\*ULN; blood urea nitrogen,creatinine, cholesterol,triglycerides:\>1.3\*ULN; sodium: \<0.95\*LLN/\>1.05\*ULN; potassium,chloride,calcium,bicarbonate:\<0.9\*LLN/\>1.1\*ULN; glucose fasting:\<0.6\*LLN/\>1.5\*ULN; creatine kinase:\>2\*ULN;urine glucose,ketone,protein:\>=1;urine WBC,RBC:\>= 20/High Power Field\[HPF\]; urine casts,hyaline casts:\>1/Low Power Field; urine bacteria:\>20/HPF. |
| Other | Number of Participants With Vital Signs Abnormalities | From Baseline (BL) up to EOS (maximum Day 25) | Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: maximum increase and decrease of greater than or equal to (\>=) 30 millimeter of mercury (mmHg) from baseline; sitting/supine diastolic blood pressure (DBP) value: maximum increase and decrease of \>=20 mmHg from baseline. |
| Other | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Screening and EOS (maximum Day 25) | Physical examinations evaluated the following body systems/organs: abdomen; ears; extremities; eyes; general appearance; head; heart; lungs; lymph nodes; mouth; musculoskeletal; nose; skin and throat. Abnormalities in physical examination were based on investigator's discretion. |
| Other | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Baseline (BL) and EOS (maximum Day 25) | Neurological examinations included: coordination; cranial nerve function (CNF); gait and station; level of consciousness (LOC); lower and upper extremity sensation; muscle strength; muscle tone; nystagmus; reflexes and speech. Abnormalities in neurological examination were based on investigator's discretion and also, some components of the neurological examination were not done for certain participants due to participant age or significant developmental impairment. Only those categories of neurological examination in which at least 10% of participants had an abnormality in any treatment group at any time point were reported in this outcome measure. |
| Other | Number of Participants With Electrocardiogram (ECG) Abnormalities | From screening up to EOS (maximum Day 25) | Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): \>=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): \>=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to \<480 msec, 480 to \<500 msec, \>=500 msec; 4) Maximum QT interval: \>=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to\< 480 msec, 480 to \<500 msec, \>=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal (maximum QTCB interval 450-\<480 msec), were reported in this outcome measure. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Day 1 up to Day 14 | Modified intent-to-treat (mITT) population included all randomized participants who took at least one dose of study drug during the double-blind treatment phase, had a baseline with at least one partial onset seizure identified by video-EEG (at least 24 hours of evaluable monitoring) and a treatment phase video-EEG. | seizures per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Day 1 up to Day 14 | mITT population included all randomized participants who took at least one dose of study drug during the double-blind treatment phase, had a baseline with at least one partial onset seizure identified by Video-EEG (at least 24 hours of evaluable monitoring) and a treatment phase Video-EEG. | 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 End of study (EOS) (maximum Day 25) | Safety population included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to EOS (maximum Day 25) | Safety population included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Adverse Events by Severity | Day 1 up to EOS (maximum Day 25) | Safety population included all randomized participants who received at least 1 dose of study drug. | events | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Laboratory Test Abnormalities | From Baseline up to EOS (maximum Day 25) | Safety population included all randomized participants who received at least 1 dose of study drug. Here, Overall number of participants analyzed= number of participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Vital Signs Abnormalities | From Baseline (BL) up to EOS (maximum Day 25) | Safety population included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Screening and EOS (maximum Day 25) | Safety population included all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies number of participants who were evaluable for the specified category for each arm respectively. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Baseline (BL) and EOS (maximum Day 25) | Safety population included all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies number of participants who were evaluable for the specified category for each arm respectively. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Electrocardiogram (ECG) Abnormalities | From screening up to EOS (maximum Day 25) | Safety population included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group330
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 1.69 | Standard Error 0.115 | seizures per 24 hours | |
| Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 1.15 | Standard Error 0.163 | seizures per 24 hours | |
| Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Placebo | 1.58 | Standard Error 0.129 | seizures per 24 hours | |
Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 30.51 | percentage of participants | ||
Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 53.57 | percentage of participants | ||
Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Placebo | 41.51 | percentage of participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | AEs | 32 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | AEs | 17 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | AEs | 38 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | SAEs | 0 | Participants |
1 to 10 of 330Source ClinicalTrials.gov
See all 330 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 7 mg/kg/Day or 6 mg/kg/Day | 71 | |
| Overall Study | STARTED | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 34 | |
| Overall Study | STARTED | Placebo | 70 | |
| Overall Study | COMPLETED | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 69 | |
| Overall Study | COMPLETED | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 33 | |
| Overall Study | COMPLETED | Placebo | 67 | |
| Overall Study | NOT COMPLETED | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 2 | |
| Overall Study | NOT COMPLETED | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events255
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 7 mg/kg/Day or 6 mg/kg/Day | 1 | 71 | |
| other | Anaemia | Blood and lymphatic system disorders | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 0 | 34 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 70 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 0 | 71 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 1 | 34 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 2 | 70 | |
| other | Bradyarrhythmia | Cardiac disorders | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 0 | 71 | |
| other | Bradyarrhythmia | Cardiac disorders | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 0 | 34 | |
| other | Bradyarrhythmia | Cardiac disorders | Placebo | 1 | 70 | |
| other | Tachycardia | Cardiac disorders | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 0 | 71 |
1 to 10 of 255Source ClinicalTrials.gov
See all 255 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 0 | 71 |
| Total, all-cause mortality | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 0 | 34 |
| Total, all-cause mortality | Placebo | 0 | 70 |
| Total, other adverse events | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 32 | 71 |
| Total, other adverse events | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 16 | 34 |
| Total, other adverse events | Placebo | 37 | 70 |
| Total, serious adverse events | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 0 | 71 |
| Total, serious adverse events | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 1 | 34 |
| Total, serious adverse events | Placebo | 4 | 70 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32189338 | 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.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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