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

Narcolepsy Clinical Trial

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 Excessive Sleepiness Associated With Narcolepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624480
• Other study ID #: C10953/1100
• Secondary ID: 2012-005510-20
• Status: Completed
• Phase: Phase 1
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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 (Any patient becoming pregnant during the study will be withdrawn from the study)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

Related Conditions & MeSH terms

• Narcolepsy
• Sleepiness

Intervention

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.

Locations

Country	Name	City	State
Finland	Teva Investigational Site 200	Helsinki
United States	Teva Investigational Site 1	Atlanta	Georgia
United States	Teva Investigational Site 2	Atlanta	Georgia
United States	Teva Investigational Site 12	Birmingham	Alabama
United States	Teva Investigational Site 17	Birmingham	Alabama
United States	Teva Investigational Site 9	Clearwater	Florida
United States	Teva Investigational Site 27	Everett	Washington
United States	Teva Investigational Site 15	Grand Blanc	Michigan
United States	Teva Investigational Site 8	Houston	Texas
United States	Teva Investigational Site 7	Little Rock	Arkansas
United States	Teva Investigational Site 20	Louisville	Kentucky
United States	Teva Investigational Site 26	Miami Lakes	Florida
United States	Teva Investigational Site 13	Oklahoma City	Oklahoma
United States	Teva Investigational Site 18	Orange	California
United States	Teva Investigational Site 23	Raleigh	North Carolina
United States	Teva Investigational Site 14	San Antonio	Texas
United States	Teva Investigational Site 16	San Diego	California
United States	Teva Investigational Site 24	Seattle	Washington
United States	Teva Investigational Site 5	Spring Hill	Florida
United States	Teva Investigational Site 4	Stanford	California
United States	Teva Investigational Site 10	Toledo	Ohio
United States	Teva Investigational Site 19	West Chester	Pennsylvania
United States	Teva Investigational Site 3	West Seneca	New York
United States	Teva Investigational Site 25	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma drug concentration (Cmax) by inspection		Day 1 + up to 72 hours after administration
Primary	Time to maximum observed plasma drug concentration (tmax) by inspection		Day 1 + up to 72 hours after administration
Primary	Area under the plasma drug concentration by time curve from time 0 to infinity		Day 1 + up to 72 hours after administration
Primary	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
Primary	Terminal half-life		Day 1 + up to 72 hours after administration
Primary	Terminal elimination rate constant		Day 1 + up to 72 hours after administration
Primary	Apparent total plasma clearance		Day 1 + up to 72 hours after administration
Primary	Apparent volume of distribution		Day 1 + up to 72 hours after administration
Primary	Predicted accumulation ratio		Day 1 + up to 72 hours after administration
Primary	Maximum observed plasma drug concentration (Cmax)		Day 42 + up to 72 hours after administration
Primary	Time to maximum observed plasma drug concentration		Day 42 + up to 72 hours after administration
Primary	AUC over 1 dosing interval		Day 42 + up to 72 hours after administration
Primary	AUC 0-t		Day 42 + up to 72 hours after administration
Primary	Observed accumulation ratio		Day 42 + up to 72 hours after administration
Primary	Steady-state accumulation ratio		Day 42 + up to 72 hours after administration
Secondary	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.	2 Days (Baseline + Day 1)
Secondary	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.	Day 42
Secondary	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.	Day 1
Secondary	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	Outpatient Visits Weeks 1 through 5, once per week
Secondary	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	Day 42