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A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Pregabalin As Adjunctive Therapy In Children 1 month through < 4 Years of Age with Partial Onset Seizures  

PHRR140909-000232

A0081042

2014-CT0209

A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Pregabalin As Adjunctive Therapy In Children 1 month through < 4 Years of Age with Partial Onset Seizures

Adjunctive therapy for children 1 month (44 weeks gestational age) through < 4 years of age inclusive with partial onset seizures with or without secondary generalization.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2014-09-05 1 2014-10-05 0000-00-00

Completed

Institution Classification Region LTO #
Pfizer Inc. - USA Private Business United States of America N/A
Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR CDRR-NCR-CRO-4
Institution Region
Pfizer Inc. NCR
Name E-Mail Institution and Institution Address
Bryan Christopher Uy-Barreta BryanChristopher.Uy-Barreta@parexel.com 15th Floor Philamlife Tower,8767 Paseo De Roxas, Makati City
Name E-Mail Institution and Institution Address
Dr. Maaliddin Biruar Maaliddin.Biruar@parexel.com 15th Floor Philamlife Tower,8767 Paseo De Roxas, Makati City
Name Expertise Affiliation
Jo Janette Resurreccion De La Calzada, MD Neurologist Cebu Doctors' University Hospital
Margaret S. Modequillo, MD Neurologist Perpetual Succour Hospital
Maria Antonia Aurora Moral-Valencia, MD Neurologist University of Santo Tomas Hospital
Marilyn H. Ortiz, MD Neurologist Philippine Children's Medical Center
Marissa B. Lukban, MD Neurologist Manila Doctors Hospital
Martha L. Bolanos, MD Neurologist Metropolitan Medical Center
Project Location Institutional Ethics Review Board
Cebu Doctors' University Hospital Cebu Doctors' University Hospital - Institutional Ethics Review Committee
Perpetual Succour Hospital Perpetual Succour Hospital Institutional Ethics and Review Board
University of Santo Tomas Hospital University of Santo Tomas Hospital Institutional Review Board
Philippine Children's Medical Center Philippine Children's Medical Center IRB - Ethics Committee
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
Metropolitan Medical Center Institutional Review Board of Metropolitan Medical Center, Inc.

seizure

The primary objective of this study is to evaluate the efficacy of two dose levels of pregabalin compared to placebo as an adjunctive treatment in reducing the frequency of partial onset seizures in pediatric subjects 1 month through

To evaluate the efficacy of pregabalin compared with placebo on the frequency of partial onset seizures as determined by responder rate in pediatric subjects 1 month through < 4 years of age. To assess the safety and tolerability of pregabalin in pediatric subjects 1 month through

Recruiting

  • Belgium
  • Bulgaria
  • China
  • Croatia
  • France
  • Greece
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • Netherlands
  • Philippines
  • Poland
  • Romania
  • Serbia and Montenegro
  • Singapore
  • South Africa
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom
  • United States

Clinical Trial

A0081042

Unspecified

2014-02-25

0000-00-00

10

Unspecified

recruitment is ongoing.

2014-09-05

Inclusion Criteria Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)/guardian(s) have been informed of all pertinent aspects of the study. When there are 2 parents, or 2 guardians, consent should be obtained from both of the child’s parents/guardians if present at the meeting where the informed consent document is signed. 2. Subjects and Parent(s)/guardian(s)/caregiver(s) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Male and female subjects, 1 month (44 weeks gestational age) through 30.0 kg. 17. Weight >30.0 kg.

Interventional

Pregabalin

Pregabalin [CI-1008, (S)-3-(amino methyl)-5-methylhexanoic acid] binds with high affinity to the 2 site (an auxiliary subunit of voltage gated calcium channels) in central nervous system tissues.

None

Randomized

Double Blind

Unspecified

Unspecified

The primary objective of this study is to evaluate the efficacy of two dose levels of pregabalin compared to placebo as an adjunctive treatment in reducing the frequency of partial onset seizures in pediatric subjects 1 month through

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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