Phase 3 N=54 Treatment

Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures

Epilepsies, Partial

Bottom Line

View on ClinicalTrials.gov: NCT00448916 ↗

Enrolled (actual)

Serious AEs

22.2%

Results posted

Dec 2014

Primary outcome: Primary: Number of Participants With Adverse Events (AE). — 14; 13; 11; 9 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Pregabalin (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events (AE).	14; 13; 11; 9; 8; 3	—
SECONDARY Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.	2; 1; 0; 0; 1; 1	—
SECONDARY Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.	1; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).	12; 5; 8; 3; 5; 7	—
SECONDARY Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).	2; 3; 1; 1; 2; 1	—
SECONDARY Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months).	0; 0; 0; 0; 5; 2	—
SECONDARY Derived Body Mass Index Data (BMI) at Month 12/Early Termination.	16.2; 18.0; 20.6; 24.8	—
SECONDARY Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.	0.1; 0.1; -0.1; 0.4; 0.3; 0.4	—
SECONDARY Height at Month 12/Early Termination.	83.3; 109.9; 145.6; 167.3	—
SECONDARY Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Hematotolgical Abnormalities.	1; 1; 0; 0; 1; 0	—
SECONDARY Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy).	1; 1; 0; 1	—
SECONDARY Number of Participants With Abnormalities in Endocrine Panel (Hormones).	0; 1; 0; 0; 0; 0	—
SECONDARY Number of Participants With Abnormalities in Creatine Kinase.	0; 1; 1; 4	—
SECONDARY Seizure Frequency.	NA; NA; NA; NA	—
SECONDARY Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).	0; 1; 1; 0; 2; 5	—

Summary

The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.

Eligibility Criteria

Inclusion Criteria

Partial onset seizures, incompletely controlled on 1-3 medications
At least 1 seizure per 28 days, on average
Completion of study A0081074

Exclusion Criteria

Primary generalized seizures
Progressive CNS pathology
Failure to tolerate pregabalin in study A0081074

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00448916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.