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Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01624480
First received: June 18, 2012
Last updated: December 8, 2015
Last verified: December 2015
June 18, 2012
December 8, 2015
July 2012
September 2015   (Final data collection date for primary outcome measure)
  • 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 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 ]
  • 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 plasma drug concentration of 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.
  • Elimination half-life [ Time Frame: Day 1 + up to 72 hours after administration ]
    The elimination half-life of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) calculated 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.
  • Terminal elimination rate constant [ Time Frame: Day 1 + up to 72 hours after administration ]
    The elimination rate constant of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) calculated 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 mornings of day 1 of period 1.
  • Apparent total plasma clearance [ Time Frame: Day 1 + up to 72 hours after administration ]
    The apparent total plasma clearance of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) calculated 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.
  • Apparent volume of distribution [ Time Frame: Day 1 + up to 72 hours after administration ]
    The apparent volume of distribution of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) calculated 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.
  • Predicted accumulation ratio [ Time Frame: Day 1 + up to 72 hours after administration ]
    The predicted accumulation ratio 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.
  • Maximum observed plasma drug concentration (Cmax) [ Time Frame: Day 42 + 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 42 of period 2.
  • Time to maximum observed plasma drug concentration [ Time Frame: Day 42 + 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 42 of period 2.
  • AUC over 1 dosing interval [ Time Frame: Day 42 + up to 72 hours after administration ]
    The AUC over 1 dosing interval for armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) calculated 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 day 42 of period 2.
  • AUC 0-t [ Time Frame: Day 42 + up to 72 hours after administration ]
    The AUC from time 0 to the time of the last measurable plasma drug concentration for armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) calculated 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 42 of period 2.
  • Terminal elimination constant λz [ Time Frame: Day 42 + up to 72 hours after administration ]
    The elimination rate constant of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) calculated 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 42 of period 2.
  • Observed accumulation ratio [ Time Frame: Day 42 + up to 72 hours after administration ]
    The observed accumulation ratio of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) calculated 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 42 of period 2.
  • Steady-state accumulation ratio [ Time Frame: Day 42 + up to 72 hours after administration ]
    The steady-state accumulation ratio of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) calculated 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 42 of period 2.
Complete list of historical versions of study NCT01624480 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
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 Excessive Sleepiness Associated With Narcolepsy
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Narcolepsy
Drug: Armodafinil
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.
Other Names:
  • R-modafinil
  • CEP-10953
  • Experimental: Armodafinil 50 mg
    In period 1, patients will receive a single 50-mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose daily on days 1 through 42.
    Intervention: Drug: Armodafinil
  • Experimental: Armodafinil 100 mg
    In period 1, patients will receive a single 100 mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose on day 1 then daily 100-mg doses on days 2 through 42.
    Intervention: Drug: Armodafinil
  • Experimental: Armodafinil 150 mg
    In period 1, patients will receive a single 150-mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose on day 1, 100-mg doses on days 2 and 3, then daily 150-mg doses on days 4 through 42.
    Intervention: Drug: Armodafinil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2015
September 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent is obtained from each patient's parent or legal guardian and written assent is obtained from each patient.
  • The patient is a male or female 6 through 17 years of age with a body mass index (BMI) equal to or greater than 10th percentile for age and gender, inclusive.
  • The patient has a diagnosis of narcolepsy with cataplexy or narcolepsy without cataplexy according to the criteria established by the International Classification of Sleep Disorders (ICSD)-2 for narcolepsy.

Exclusion Criteria:

  • The patient has any clinically significant uncontrolled medical condition (treated or untreated) other than narcolepsy.
  • The patient has a clinically significant deviation from normal in ECG, physical examination or vital sign findings, as determined by the investigator or medical monitor.
  • The patient is pregnant or lactating. (Any patient becoming pregnant during the study will be withdrawn from the study)
  • The patient has any history of seizures, including febrile seizures, or a family history of seizures (in parents or siblings) which is not a consequence of trauma, stroke, or metabolic disturbance.
  • The patient has a history of head trauma associated with loss of consciousness.
  • The patient has current suicidal ideation, a history of a suicidal ideation, or a history of a suicide attempt.
  • The patient has a history of major depressive disorder, bipolar disorder, other significant mood disorders, schizophrenia and other psychotic disorders, eating disorders, or has a family history of suicide.
  • The patient has left ventricular hypertrophy or the patient has mitral valve prolapse and has experienced mitral valve prolapse syndrome.
  • The patient has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the 1st dose of study drug, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the 1st dose of study drug.

    • The patient has used any monoamine oxidase inhibitors (MAOIs) or stimulants within 14 days or 5 half-lives (whichever is longer) of the baseline visit.
    • The patient has used modafinil or armodafinil within 4 weeks of the baseline visit.
    • The patient has used an inducer of CYP3A4/5 within 28 days prior to study drug administration.
    • The patient has used an inhibitor of CYP3A4/5 within 14 days or 5 half lives (whichever is longer) prior to study drug administration.
    • The patient has a known sensitivity or idiosyncratic reaction to any compound present in modafinil or armodafinil, their related compounds, or to any metabolites or compound listed as being present in these medications.
    • The patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions
    • Other criteria apply, please contact the investigator for additional information
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Finland,   United States
 
 
NCT01624480
C10953/1100
2012-005510-20 ( EudraCT Number )
No
Not Provided
Not Provided
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Study Director: Teva Medical Expert, MD TEVA
Teva Pharmaceutical Industries
December 2015

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