Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness

NCT00214968 | Completed Phase 3

• 1 other identifier: C1538/3034/ES/MN
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to 6 months.

Conditions

Narcolepsy

Outcome Measures

Primary Outcomes (1)

• Adverse event evaluations

  Evaluate the safety and tolerability of treatment in children and adolescents with excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea/hypopnea syndrome, when administered for up to 6 months

  up to 6 months

Secondary Outcomes (2)

• Composite Ratings of severity of illness

  up to 6 months

• Total score from the Pediatric Daytime Sleepiness Scale (PDSS)

  up to 6 months

Study Arms (1)

Modafinil

EXPERIMENTAL

Subjects began taking Provigil at a dosage of 100 mg/day (1 tablet) and increased their dosage by 100 mg/day each week for up to 4 weeks

Drug: Modafinil

Interventions

Modafinil DRUG

maximum dosage 400 mg/day (4 tablets)

Also known as: Provigil

Modafinil

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• have self-induced sleep deprivation/poor sleep hygiene
• have a past or present seizure disorder (except history of single febrile seizure), a history of psychosis, or of clinically significant head trauma (eg, brain damage) or past neurosurgery
• have a history of suicide attempt, or are at suicidal risk
• a clinically significant drug sensitivity to stimulants such as amfetamine, dexamfetamine, or methylphenidate; and/or modafinil or any of its components
• use of any monoamine oxidase (MAO) inhibitors or selective serotonin reuptake inhibitors (SSRIs) within 2 weeks of the baseline visit (NOTE: SSRIs will be allowed for cataplexy if the patient has been on a stable dose for at least 1 month.)
• received any investigational drug (except modafinil) within 4 weeks of the baseline visit
• any disorder that could interfere with drug absorption, distribution, metabolism, or excretion (including previous gastrointestinal surgery)
• active, clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other major clinically significant disorder/disease
• any clinically significant deviation from the normal range(s) in the physical examination or ECG findings, or clinical laboratory test results (ie, serum chemistry, hematology) at the screening or baseline visit
• absolute neutrophil count (ANC) below the lower limit of normal at screening (NOTE: If the ANC is below the lower limit of normal at the baseline visit, the medical monitor will be consulted for continued eligibility in the study.)
• a history of alcohol, narcotic, or any other substance abuse
• pregnant or lactating/nursing girl

Sponsors & Collaborators

• Cephalon: lead

MeSH Terms

Conditions

Narcolepsy

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: May 31, 2012

Record last verified: 2012-05