Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures
A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pregabalin In Pediatric Patients With Partial Onset Seizures
1 other identifier
interventional
65
3 countries
18
Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2007
Longer than P75 for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
March 17, 2014
CompletedFebruary 11, 2021
January 1, 2014
5.6 years
February 16, 2007
September 16, 2013
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment
Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.
Baseline to Day 7
Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment
Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.
Day 8 up to 28 days after open-label dose of study medication
Secondary Outcomes (14)
Number of Participants With Clinically Significant Change in Physical and Neurological Findings
Baseline up to 7 days post-last dose of study medication
28-Day Seizure Frequency Rate
Baseline up to 7 days post-last dose of study medication
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis
Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis
Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis
Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
- +9 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPregabalin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Partial onset seizures, incompletely controlled on 1-3 medications
- At least 1 seizure per 28 days, on average
You may not qualify if:
- Primary generalized seizures
- Progressive CNS pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Pfizer Investigational Site
Mobile, Alabama, 36604, United States
Pfizer Investigational Site
Mobile, Alabama, 36693, United States
Pfizer Investigational Site
Phoenix, Arizona, 85016, United States
Pfizer Investigational Site
Jonesboro, Arkansas, 72401, United States
Pfizer Investigational Site
Little Rock, Arkansas, 72205, United States
Pfizer Investigational Site
San Francisco, California, 94143, United States
Pfizer Investigational Site
Gulf Breeze, Florida, 32561, United States
Pfizer Investigational Site
Pensacola, Florida, 32504, United States
Pfizer Investigational Site
Tampa, Florida, 33603, United States
Pfizer Investigational Site
Tampa, Florida, 33609, United States
Pfizer Investigational Site
Springfield, Missouri, 65804, United States
Pfizer Investigational Site
Buffalo, New York, 14222, United States
Pfizer Investigational Site
Durham, North Carolina, 27710, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
San Antonio, Texas, 78258, United States
Pfizer Investigational Site
Guadalajara, Jalisco, 44280, Mexico
Pfizer Investigational Site
Mexico City, Mexico City, 06720, Mexico
Pfizer Investigational Site
Seoul, 120-752, South Korea
Related Publications (1)
Mann D, Liu J, Chew ML, Bockbrader H, Alvey CW, Zegarac E, Pellock J, Pitman VW. Safety, tolerability, and pharmacokinetics of pregabalin in children with refractory partial seizures: a phase 1, randomized controlled study. Epilepsia. 2014 Dec;55(12):1934-43. doi: 10.1111/epi.12830. Epub 2014 Nov 6.
PMID: 25377429DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Results are reported for AUCtau for multiple-dose PK analysis and AUC (0-∞) for single-dose PK analysis, instead of AUC (0-24), as per change in planned analysis.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2007
First Posted
February 19, 2007
Study Start
April 1, 2007
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
February 11, 2021
Results First Posted
March 17, 2014
Record last verified: 2014-01