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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00437281
• Date of registration: 16/02/2007
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures
• Scientific 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
• Date of first enrolment: April 2007
• Target sample size: 65
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00437281
• Study type: Interventional
• Phase: Phase 1/Phase 2

Countries of recruitment

France, Korea, Republic of, Mexico, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 1 Month
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsies, Partial

Intervention(s)

Drug: Placebo

Drug: Pregabalin

Primary Outcome(s)

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]

Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment [Time Frame: Baseline to Day 7]

Secondary Outcome(s)

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]

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]

Renal Clearance (CLr): Multiple-Dose Analysis [Time Frame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8]

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]

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]

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]

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]

28-Day Seizure Frequency Rate [Time Frame: Baseline up to 7 days post-last dose of study medication]

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]

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]

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]

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]: Single-Dose Analysis [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 [Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8]

Renal Clearance (CLr): Single-Dose Analysis [Time Frame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8]

Secondary ID(s)

A0081074

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/03/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00437281