Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.
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Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs
Timeframe: Baseline (Day 1) up to 13 Months
Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months
Timeframe: Baseline up to 12 Months
Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities
Timeframe: Baseline up to 12 months
Number of Participants With Tanner Staging Evaluation at Baseline
Timeframe: Baseline (Day 1)
Number of Participants With Tanner Staging Evaluation at Month 12
Timeframe: Month 12
Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months
Timeframe: Baseline up to 12 Months
Absolute Values for Body Height at Baseline
Timeframe: Baseline
Absolute Values for Body Height at Month 12
Timeframe: Month 12
Number of Participants With Incidence of Laboratory Abnormalities
Timeframe: Baseline up to 12 Months
Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters
Timeframe: Baseline up to 12 Months
28-Days Seizure Rate at Week 1
Timeframe: Week 1
28-Days Seizure Rate at Month 1
Timeframe: Month 1
28-Days Seizure Rate at Month 2
Timeframe: Month 2
28-Days Seizure Rate at Month 4
Timeframe: Month 4
28-Days Seizure Rate at Month 6
Timeframe: Month 6
28-Days Seizure Rate at Month 9
Timeframe: Month 9
28-Days Seizure Rate at Month 12/Early Termination
Timeframe: Month 12/Early Termination