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

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Narcolepsy

Treatments: Drug: Armodafinil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01624480

2012-005510-20 (EudraCT Number)

C10953/1100

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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 (Any patient becoming pregnant during the study will be withdrawn from the study)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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Armodafinil 50 mg

Experimental group

Description:

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.

Treatment:

Drug: Armodafinil

Armodafinil 100 mg

Experimental group

Description:

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.

Treatment:

Drug: Armodafinil

Armodafinil 150 mg

Experimental group

Description:

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.

Treatment:

Drug: Armodafinil