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Clinical Trials/NCT00448916
NCT00448916CompletedPhase 3

A 12-month Open-label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Pregabalin In Pediatric Patients With Partial Onset Seizures

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.18 sites in 3 countries54 target enrollmentStarted: May 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
54
Locations
18
Primary Endpoint
Number of Participants With Adverse Events (AE).
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Month to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Pregabalin

Experimental

Orally-administered pregabalin

Intervention: Pregabalin (Drug)

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AE).

Time Frame: 12 Months

An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect.

Secondary Outcomes

  • Derived Body Mass Index Data (BMI) at Month 12/Early Termination.(Month 12/Early Termination)
  • 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.(Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up)
  • Height at Month 12/Early Termination.(Month 12/Early Termination)
  • Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).(Week 1 to 12 Months)
  • Number of Participants With Hematotolgical Abnormalities.(12 Months)
  • 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.(Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.)
  • Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).(Visit 1 to 12 Months)
  • 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.(Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up)
  • Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).(Visit 1 to 12 Months)
  • Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months).(Visit 1 to 12 Months)
  • Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy).(12 Months)
  • Number of Participants With Abnormalities in Endocrine Panel (Hormones).(12 Months)
  • Number of Participants With Abnormalities in Creatine Kinase.(12 Months)
  • Seizure Frequency.(28 Days)
  • Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).(12 Months)

Investigators

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (18)

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