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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The armodafinil tablets to be used in this study contain 50 mg of armodafinil and the following inactive ingredients: lactose monohydrate, starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and povidone.
Teva Investigational Site 12
Birmingham, Alabama, United States
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
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Teva Investigational Site 17
Birmingham, Alabama, United States
Teva Investigational Site 7
Little Rock, Arkansas, United States
Teva Investigational Site 18
Orange, California, United States
Teva Investigational Site 16
San Diego, California, United States
Teva Investigational Site 4
Stanford, California, United States
Teva Investigational Site 9
Clearwater, Florida, United States
Teva Investigational Site 26
Miami Lakes, Florida, United States
Teva Investigational Site 5
Spring Hill, Florida, United States
Teva Investigational Site 25
Winter Park, Florida, United States
...and 14 more locations
AUC over 1 dosing interval
Time frame: Day 42 + up to 72 hours after administration
AUC 0-t
Time frame: Day 42 + up to 72 hours after administration
Observed accumulation ratio
Time frame: Day 42 + up to 72 hours after administration
Steady-state accumulation ratio
Time frame: Day 42 + up to 72 hours after administration
Mean sleep latency
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.
Time frame: 2 Days (Baseline + Day 1)
Mean sleep latency
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.
Time frame: Day 42
Clinical Global Impression of Change (CGI-C)
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.
Time frame: Day 1
Clinical Global Impression of Change (CGI-C)
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
Time frame: Outpatient Visits Weeks 1 through 5, once per week
Clinical Global Impression of Change (CGI-C)
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
Time frame: Day 42