Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
- Registration Number
- NCT01624480
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
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The patient has any clinically significant uncontrolled medical condition (treated or untreated) other than narcolepsy.
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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.
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The patient is pregnant or lactating. (Any patient becoming pregnant during the study will be withdrawn from the study)
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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.
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The patient has a history of head trauma associated with loss of consciousness.
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The patient has current suicidal ideation, a history of a suicidal ideation, or a history of a suicide attempt.
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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.
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The patient has left ventricular hypertrophy or the patient has mitral valve prolapse and has experienced mitral valve prolapse syndrome.
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Armodafinil 50 mg Armodafinil 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. Armodafinil 100 mg Armodafinil 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. Armodafinil 150 mg Armodafinil 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.
- Primary Outcome Measures
Name Time Method Maximum observed plasma drug concentration (Cmax) by inspection Day 1 + up to 72 hours after administration Time to maximum observed plasma drug concentration (tmax) by inspection Day 1 + up to 72 hours after administration Area under the plasma drug concentration by time curve from time 0 to infinity 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 Day 1 + up to 72 hours after administration Terminal half-life Day 1 + up to 72 hours after administration Terminal elimination rate constant Day 1 + up to 72 hours after administration Apparent total plasma clearance Day 1 + up to 72 hours after administration Apparent volume of distribution Day 1 + up to 72 hours after administration Predicted accumulation ratio Day 1 + up to 72 hours after administration AUC over 1 dosing interval Day 42 + up to 72 hours after administration Observed accumulation ratio Day 42 + up to 72 hours after administration Maximum observed plasma drug concentration (Cmax) Day 42 + up to 72 hours after administration Time to maximum observed plasma drug concentration Day 42 + up to 72 hours after administration AUC 0-t Day 42 + up to 72 hours after administration Steady-state accumulation ratio Day 42 + up to 72 hours after administration
- Secondary Outcome Measures
Name Time Method Mean sleep latency 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) 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
Trial Locations
- Locations (24)
Teva Investigational Site 23
🇺🇸Raleigh, North Carolina, United States
Teva Investigational Site 1
🇺🇸Atlanta, Georgia, United States
Teva Investigational Site 7
🇺🇸Little Rock, Arkansas, United States
Teva Investigational Site 15
🇺🇸Grand Blanc, Michigan, United States
Teva Investigational Site 200
🇫🇮Helsinki, Finland
Teva Investigational Site 12
🇺🇸Birmingham, Alabama, United States
Teva Investigational Site 8
🇺🇸Houston, Texas, United States
Teva Investigational Site 24
🇺🇸Seattle, Washington, United States
Teva Investigational Site 17
🇺🇸Birmingham, Alabama, United States
Teva Investigational Site 13
🇺🇸Oklahoma City, Oklahoma, United States
Teva Investigational Site 14
🇺🇸San Antonio, Texas, United States
Teva Investigational Site 4
🇺🇸Stanford, California, United States
Teva Investigational Site 2
🇺🇸Atlanta, Georgia, United States
Teva Investigational Site 9
🇺🇸Clearwater, Florida, United States
Teva Investigational Site 26
🇺🇸Miami Lakes, Florida, United States
Teva Investigational Site 16
🇺🇸San Diego, California, United States
Teva Investigational Site 5
🇺🇸Spring Hill, Florida, United States
Teva Investigational Site 18
🇺🇸Orange, California, United States
Teva Investigational Site 25
🇺🇸Winter Park, Florida, United States
Teva Investigational Site 20
🇺🇸Louisville, Kentucky, United States
Teva Investigational Site 3
🇺🇸West Seneca, New York, United States
Teva Investigational Site 10
🇺🇸Toledo, Ohio, United States
Teva Investigational Site 19
🇺🇸West Chester, Pennsylvania, United States
Teva Investigational Site 27
🇺🇸Everett, Washington, United States