Clinical Trial: Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Open-Label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Single and Multiple Doses of Armodafinil (50, 100, and 150 mg/Day) in Children and Adolescents With
Brief Summary: This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with excessive sleepiness associated with narcolepsy.
Detailed Summary:
Sponsor: Teva Pharmaceutical Industries
Current Primary Outcome:
- Maximum observed plasma drug concentration (Cmax) by inspection [ Time Frame: Day 1 + up to 72 hours after administration ]
- Time to maximum observed plasma drug concentration (tmax) by inspection [ Time Frame: Day 1 + up to 72 hours after administration ]
- Area under the plasma drug concentration by time curve from time 0 to infinity [ Time Frame: Day 1 + up to 72 hours after administration ]
- Area under the plasma drug concentration by time curve from time 0 to the time of the last measurable drug concentration [ Time Frame: Day 1 + up to 72 hours after administration ]
- Terminal half-life [ Time Frame: Day 1 + up to 72 hours after administration ]
- Terminal elimination rate constant [ Time Frame: Day 1 + up to 72 hours after administration ]
- Apparent total plasma clearance [ Time Frame: Day 1 + up to 72 hours after administration ]
- Apparent volume of distribution [ Time Frame: Day 1 + up to 72 hours after administration ]
- Predicted accumulation ratio [ Time Frame: Day 1 + up to 72 hours after administration ]
- Maximum observed plasma drug concentration (Cmax) [ Time Frame: Day 42 + up to 72 hours after administration ]
- Time to maximum observed plasma drug concentration [ Time Frame: Day 42 + up to 72 hours after administration ]
- AUC over 1 dosing interval [ Time Frame: Day 42 + up to 72 hours after
Original Primary Outcome:
- Maximum observed plasma drug concentration (Cmax) by inspection [ Time Frame: Day 1 + up to 72 hours after administration ]The maximum plasma concentration of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) based on blood samples obtained prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours after administration of armodafinil on the morning of day 1 of period 1.
- Time to maximum observed plasma drug concentration (tmax) by inspection [ Time Frame: Day 1 + up to 72 hours after administration ]The time to reach the maximum plasma concentration of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) based on blood samples obtained prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours after administration of armodafinil on the morning of day 1 of period 1 day 1 of period 1.
- Area under the plasma drug concentration by time curve from time 0 to infinity [ Time Frame: Day 1 + up to 72 hours after administration ]The AUC from time 0 to infinity for armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) calculated using blood samples obtained prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours after administration of armodafinil on the morning of day 1 of period 1.
- Area under the plasma drug concentration by time curve from time 0 to the time of the last measurable drug concentration [ Time Frame: Day 1 + up to 72 hours after administration ]The AUC from time 0 to the time of the last measurable plasm
Current Secondary Outcome:
- Mean sleep latency [ Time Frame: 2 Days (Baseline + Day 1) ]An objective assessment of sleepiness that measures the likelihood of falling asleep. The test consists of multiple naps performed on the day before study drug administration in period 1 and on the day of study drug administration in period 1. For each nap, sleep latency will be measured as the elapsed time from lights-out to the first epoch scored as sleep. Mean sleep latency is calculated for each day as the average of the sleep latencies from each nap on that day.
- Mean sleep latency [ Time Frame: Day 42 ]An assessment by the investigator of change in the patient's severity of excessive sleepiness during the course of the study. The clinician will ask the guardian to assess the child's home behavior over the past week.
- Clinical Global Impression of Change (CGI-C) [ Time Frame: Day 1 ]An assessment by the investigator of change in the patient's severity of excessive sleepiness during the course of the study. The clinician will ask the guardian to assess the child's home behavior over the past week.
- Clinical Global Impression of Change (CGI-C) [ Time Frame: Outpatient Visits Weeks 1 through 5, once per week ]The Clinical Global Impression of Change (CGI-C) is an assessment by the investigator of change in the patient's severity of excessive sleepiness during the course of the study. The clinician will ask the guardian to assess the child's home behavior over the past week. The CGI-C ratings will be assessed using the following 7 categories and scoring assignments: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse
- Clinical Global Impression of Change (CGI-C) [ Time Frame: Day 42 ]The Clinical Global Impression of Change (CGI-C) is an assessment by the investigator of change in the patient's severity of excessive sleepiness during the course of the study. The clinician will ask the guardian to assess the child's home behavior over the past week. The CGI-C ratings will be assessed using the following 7 categories and scoring assignments: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse
Original Secondary Outcome: Same as current
Information By: Teva Pharmaceutical Industries
Dates:
Date Received: June 18, 2012
Date Started: July 2012
Date Completion:
Last Updated: December 8, 2015
Last Verified: December 2015
- Mean sleep latency [ Time Frame: 2 Days (Baseline + Day 1) ]
- Maximum observed plasma drug concentration (Cmax) by inspection [ Time Frame: Day 1 + up to 72 hours after administration ]