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A 12-Month Study To Evaluate The 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

NCT01463306 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 605

Last updated 2021-01-20

Study results available
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Summary

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.

Conditions

  • Epilepsy, Partial Seizures
  • Epilepsy, Primary Generalized Tonic-Clonic Seizures

Interventions

DRUG

Pregabalin

Pregabalin administered as either capsule or liquid oral formulations. Subjects \<4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ≥4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day.

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
1 Month
Max Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-21
Primary Completion
2019-08-22
Completion
2019-08-22
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • China
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Lebanon
  • Malaysia
  • Montenegro
  • Philippines
  • Poland
  • Romania
  • Russia
  • Serbia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01463306 on ClinicalTrials.gov