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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 is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Teva Pharmaceutical Industries
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01624480
First received: June 18, 2012
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Narcolepsy
Drug: Armodafinil
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Maximum observed plasma drug concentration (Cmax) by inspection [ Time Frame: Day 1 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • Time to maximum observed plasma drug concentration (tmax) by inspection [ Time Frame: Day 1 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • Area under the plasma drug concentration by time curve from time 0 to infinity [ Time Frame: Day 1 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Terminal half-life [ Time Frame: Day 1 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • Terminal elimination rate constant [ Time Frame: Day 1 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • Apparent total plasma clearance [ Time Frame: Day 1 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • Apparent volume of distribution [ Time Frame: Day 1 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • Predicted accumulation ratio [ Time Frame: Day 1 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • Maximum observed plasma drug concentration (Cmax) [ Time Frame: Day 42 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • Time to maximum observed plasma drug concentration [ Time Frame: Day 42 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • AUC over 1 dosing interval [ Time Frame: Day 42 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • AUC 0-t [ Time Frame: Day 42 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • Observed accumulation ratio [ Time Frame: Day 42 + up to 72 hours after administration ] [ Designated as safety issue: No ]
  • Steady-state accumulation ratio [ Time Frame: Day 42 + up to 72 hours after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean sleep latency [ Time Frame: 2 Days (Baseline + Day 1) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 45
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
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 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.
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

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624480

Contacts
Contact: Teva U.S. Medical Information 1-800-896-5855

  Show 25 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Teva Medical Expert, MD TEVA
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01624480     History of Changes
Other Study ID Numbers: C10953/1100, 2012-005510-20
Study First Received: June 18, 2012
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Pediatric Narcolepsy

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Dyssomnias
Mental Disorders
Nervous System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic
Armodafinil
Modafinil
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on November 23, 2014