Clinical trial NCT00437281: Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures
Official title: A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pregabalin In Pediatric Patients With Partial Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Epilepsies, Partial
Keywords: Partial-onset seizures; epilepsy; pediatric; pregabalin; safety; tolerability; pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Partial onset seizures, incompletely controlled on 1-3 medications
* At least 1 seizure per 28 days, on average

Exclusion Criteria:

* Primary generalized seizures
* Progressive CNS pathology

Primary outcomes:
measure: Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment
timeFrame: Baseline to Day 7
measure: Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment
timeFrame: Day 8 up to 28 days after open-label dose of study medication
Secondary outcomes:
measure: Number of Participants With Clinically Significant Change in Physical and Neurological Findings
timeFrame: Baseline up to 7 days post-last dose of study medication
measure: 28-Day Seizure Frequency Rate
timeFrame: Baseline up to 7 days post-last dose of study medication
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
measure: Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
measure: Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
measure: Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
measure: Plasma Decay Half-Life (t1/2): Single-Dose Analysis
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
measure: Apparent Oral Clearance (CL/F): Multiple-Dose Analysis
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
measure: Apparent Oral Clearance (CL/F): Single-Dose Analysis
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
measure: Renal Clearance (CLr): Multiple-Dose Analysis
timeFrame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
measure: Renal Clearance (CLr): Single-Dose Analysis
timeFrame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Gulf Breeze
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.