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PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE3

PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

A 1 Year Open Label, Flexible Dosage Extension Study to Assess the Safety and Continued Effectiveness of PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

NCT00107848•Cephalon

View on ClinicalTrials.gov

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 OSAHS (obstructive sleep apnea/hypopnea), when administered for up to 12 months. Safety and tolerability will be evaluated throughout the study by means of adverse event information, clinical laboratory test results, vital signs measurements, and body weight and height measurements; quarterly physical examination findings; and 12 lead electrocardiograph (ECG) evaluations at the end of the study. In addition, the cognitive and behavioral effects of PROVIGIL will be assessed quarterly as measured by the Child Behavior Checklist for Ages 6-18 (CBCL/6-18), a brief psychiatric interview, and the Kaufman Brief Intelligence Test (KBIT 2).

Detailed Description

PROVIGIL is a registered trademark of Genelco, S.A., licensed to Cephalon, Inc.

Eligibility

Age

6 - 16 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Appropriate written assent is obtained from the patient and written informed consent is obtained from the parent or legal guardian (defined by the IEC/IRB)
•A boy or girl aged 6 through 16 years (at the start of the previous double blind study), inclusive, who participated in study C1538/3027/NA/MN or C1538/3028/AP/MN
•Have a diagnosis (as established in the previous double blind study) of narcolepsy (or presumed narcolepsy) or OSAHS according to the criteria established by the International Classification of Sleep Disorders (ICSD) manual of the American Academy of Sleep Medicine (AASM)
•Continue to be in good health as determined by a medical and psychiatric history, ECGs, physical examination findings, serum chemistry, hematology, and urinalysis
•Have blood pressure values greater than those for the 5th percentile and less than the 95th percentile on the National High Blood Pressure Education Program guidelines for blood pressure levels for boys and girls ages 6 through 16 years
•Girls who are post menarche or sexually active who have a negative urine pregnancy test at the screening/baseline visit, must be using a medically acceptable method of birth control, and must agree to continued use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptives (oral, topical \[patch\], implanted, and injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence
•No positive urine drug screen (UDS) for any illicit drug or alcohol (ethanol) at baseline visit, unless a false positive is suspected, in which case the UDS will be repeated. If the patient has a positive drug screen for methylphenidate or amphetamine at screening, the patient must have a negative UDS after a washout period and prior to baseline.
•Have a parent or legal guardian who is willing to participate in the study

Exclusion Criteria

•Have self induced sleep deprivation/poor sleep hygiene
•Have a past or present seizure disorder (except history of a 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 amphetamine, dextroamphetamine, methylphenidate, or pemoline; and modafinil or any of its components
•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 ECG or physical examination findings, or clinical laboratory (ie, hematology, serum chemistry, urinalysis) test results at the screening/baseline visit
•Absolute neutrophil count (ANC) below the lower limit of normal at the baseline visit (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 seated pulse outside the range of 60 through 115 bpm after resting for 5 minutes
•A total daily intake of more than 500 mg of caffeine per day (eg, approximately ten 12 ounce caffeinated sodas, 5 cups of coffee or tea, or about 25 ounces of chocolate per day) within 1 week of the baseline visit
+1 more criteria

Locations (61)

Robert Doekel, Jr., M.D.

Birmingham, Alabama, United States

Chris M. Makris, M.D.

Birmingham, Alabama, United States

Barbara Harris, Ph.D.

Phoenix, Arizona, United States

Derek Loewy, Ph.D.

Tucson, Arizona, United States

Joseph McCarty, M.D.

Fort Smith, Arkansas, United States

Samuel Boellner, M.D.

Little Rock, Arkansas, United States

Julie Thompson-Dobkin, D.O.

Huntington Beach, California, United States

Mark Buchfuhrer, M.D.

Long Beach, California, United States

Yury Furman, M.D.

Los Angeles, California, United States

Stuart Menn, M.D.

Palm Springs, California, United States

Key Dates

Start Date

October 1, 2004

Completion Date

September 1, 2005

Last Updated

May 9, 2014

Enrollment

280

Estimated participants

Conditions

NarcolepsySleep Apnea, Obstructive

Interventions

Modafinil

DRUG

A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

NCT07363720

Narcolepsy Type 1 (NT1)Narcolepsy With Cataplexy

View study

RECRUITINGNA

Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome

NCT07446634

Sleep Apnea, Obstructive

View study

RECRUITINGPHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

Inclusion Criteria

Exclusion Criteria

A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome

A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

Long-term Evaluation of a Nasopharyngeal Airway

Extended-release Sodium Oxybate in Children

Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea