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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00437281
Other study ID # A0081074
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date April 2007
Est. completion date November 2012

Study information

Verified date January 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 1 Month to 16 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Placebo
Pregabalin
Orally-administered pregabalin

Locations

Country Name City State
Korea, Republic of Pfizer Investigational Site Seoul
Mexico Pfizer Investigational Site Guadalajara Jalisco
Mexico Pfizer Investigational Site Mexico DF
United States Pfizer Investigational Site Buffalo New York
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Gulf Breeze Florida
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Jonesboro Arkansas
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site Pensacola Florida
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Francisco California
United States Pfizer Investigational Site Springfield Missouri
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. Baseline up to 7 days post-last dose of study medication
Secondary 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. Baseline up to 7 days post-last dose of study medication
Secondary 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. Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8
Secondary Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]: Single-Dose Analysis AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). AUC (0 - 8) 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. Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Secondary 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. Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Secondary 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. Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Secondary 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). Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Secondary 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). Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Secondary 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). Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Secondary 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). Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Secondary 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). Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Secondary 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). Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Secondary 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). 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
Secondary 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). 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
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