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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
Placebo
Orally-administered pregabalin
Pfizer Investigational Site
Mobile, Alabama, United States
Pfizer Investigational Site
Mobile, Alabama, United States
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.
Time frame: 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.
Time frame: Day 8 up to 28 days after open-label dose of study medication
Number of Participants With Clinically Significant Change in Physical and Neurological Findings
Full physical examination included examination of the abdomen, breasts, lungs, lymph nodes, mouth, genitourinary, musculoskeletal and neurological systems, skin, extremities, head, heart, ears, eyes, neck, nose, ocular fundi, throat and thyroid gland. The neurological exam was performed by a pediatric neurologist or qualified investigator.
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Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Jonesboro, Arkansas, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Gulf Breeze, Florida, United States
Pfizer Investigational Site
Pensacola, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
...and 8 more locations
Time frame: Baseline up to 7 days post-last dose of study medication
28-Day Seizure Frequency Rate
Seizure frequency was reported by participant's parent or guardian from randomization to 7 days post-last dose of study medication. 28-day seizure frequency rate = (number of seizures in observation period/number of days in observation period)\*28.
Time frame: 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
Area under the curve from time zero to the end of dosing interval (AUCtau), where dosing interval was 12 hours, for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.
Time frame: 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
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis
Cmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis
Cmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis
Tmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis
Tmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Plasma Decay Half-Life (t1/2): Single-Dose Analysis
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Apparent Oral Clearance (CL/F): Multiple-Dose Analysis
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Apparent Oral Clearance (CL/F): Single-Dose Analysis
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Renal Clearance (CLr): Multiple-Dose Analysis
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
Time frame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
Renal Clearance (CLr): Single-Dose Analysis
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning was to be reported (single-dose participants).
Time frame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8