Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00437281
First received: February 16, 2007
Last updated: January 29, 2014
Last verified: January 2014

February 16, 2007
January 29, 2014
April 2007
November 2012   (final data collection date for primary outcome measure)
  • Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment [ Time Frame: Baseline to Day 7 ] [ Designated as safety issue: Yes ]
    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.
  • Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment [ Time Frame: Day 8 up to 28 days after open-label dose of study medication ] [ Designated as safety issue: Yes ]
    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.
Frequency and severity of adverse events; physical and neurologic exams; vital signs; ECGs; laboratory tests; seizure frequency throughout the 8 day study period.
Complete list of historical versions of study NCT00437281 on ClinicalTrials.gov Archive Site
  • Number of Participants With Clinically Significant Change in Physical and Neurological Findings [ Time Frame: Baseline up to 7 days post-last dose of study medication ] [ Designated as safety issue: Yes ]
    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.
  • 28-Day Seizure Frequency Rate [ Time Frame: Baseline up to 7 days post-last dose of study medication ] [ Designated as safety issue: Yes ]
    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.
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8 ] [ Designated as safety issue: No ]
    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.
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ] [ Designated as safety issue: No ]
    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.
  • Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ] [ Designated as safety issue: No ]
    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.
  • Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ] [ Designated as safety issue: No ]
    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 to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ] [ Designated as safety issue: No ]
    Tmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
  • Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ] [ Designated as safety issue: No ]
    Tmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).
  • Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ] [ Designated as safety issue: No ]
    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).
  • Plasma Decay Half-Life (t1/2): Single-Dose Analysis [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ] [ Designated as safety issue: No ]
    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).
  • Apparent Oral Clearance (CL/F): Multiple-Dose Analysis [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ] [ Designated as safety issue: No ]
    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).
  • Apparent Oral Clearance (CL/F): Single-Dose Analysis [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ] [ Designated as safety issue: No ]
    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).
  • Renal Clearance (CLr): Multiple-Dose Analysis [ Time Frame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8 ] [ Designated as safety issue: No ]
    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).
  • Renal Clearance (CLr): Single-Dose Analysis [ Time Frame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8 ] [ Designated as safety issue: No ]
    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).
Pharmacokinetic endpoints (Cmax, Tmax, AUC, Clearance, T 1/2) at Day 8.
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Epilepsies, Partial
  • Drug: Placebo
    Placebo
  • Drug: Pregabalin
    Orally-administered pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Pregabalin
    Intervention: Drug: Pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
1 Month to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico,   Korea, Republic of
 
NCT00437281
A0081074
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP