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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107848
• Other study ID #: C1538/3029/ES/MN-Open label
• Status: Completed
• Phase: Phase 3
• First received: April 8, 2005
• Last updated: May 8, 2014
• Start date: October 2004
• Est. completion date: September 2005

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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

• Continue to meet inclusion criteria from the previous study, as appropriate

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

• Pregnant or lactating/nursing; any child who becomes pregnant during the study will be withdrawn.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Disorders of Excessive Somnolence
• Narcolepsy
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Modafinil

Locations

Country	Name	City	State
Canada	Adam Moscovitch, M.D.	Calgary	Alberta
Canada	Manisha Witmans	Edmonton	Alberta
Canada	Lawrence Reinish	Parry Sound	Ontario
Canada	Leonid Kayumov, M.D.	Scarborough	Ontario
Canada	Colin Shapiro, Ph.D.	Toronto	Ontario
Canada	Mortimer Mamelak, M.D.	Toronto	Ontario
United States	D. Alan Lankford, Ph.D.	Atlanta	Georgia
United States	Gary Montgomery, M.D.	Atlanta	Georgia
United States	Jerry Silverboard, M.D.	Atlanta	Georgia
United States	John Hudson, M.D.	Austin	Texas
United States	Chris M. Makris, M.D.	Birmingham	Alabama
United States	Robert Doekel, Jr., M.D.	Birmingham	Alabama
United States	Helene A. Emsellem, M.D.	Chevy Chase	Maryland
United States	Michael Kohrman, M.D.	Chicago	Illinois
United States	Stephen H. Sheldon, D.O., FAAP	Chicago	Illinois
United States	Carol Rosen	Cleveland	Ohio
United States	Richard Bogan, M.D., FCCP	Columbia	South Carolina
United States	David Sperry, M.D.	Dallas	Texas
United States	James Cook, M.D.	Danville	Indiana
United States	James Perlstrom	Fairfax	Virginia
United States	George Zureikat, M.D.	Flint	Michigan
United States	Joseph McCarty, M.D.	Fort Smith	Arkansas
United States	Marc Raphaelson	Frederick	Maryland
United States	Elias H. Sarkis	Gainesville	Florida
United States	John Harsh, Ph.D., DABSM	Hattiesburg	Mississippi
United States	Todd J. Swick, M.D.	Houston	Texas
United States	Julie Thompson-Dobkin, D.O.	Huntington Beach	California
United States	Samuel Boellner, M.D.	Little Rock	Arkansas
United States	Mark Buchfuhrer, M.D.	Long Beach	California
United States	Yury Furman, M.D.	Los Angeles	California
United States	Karen Waters, M.D.	Louisville	Kentucky
United States	Charles Wells, Jr., M.D.	Macon	Georgia
United States	Americo Padilla, M.D.	Miami	Florida
United States	Julie Jacques, D.O.	Morristown	Tennessee
United States	Kathleen Ryan, M.D.	Mount Laurel	New Jersey
United States	Martin A. Cohn, M.D.	Naples	Florida
United States	Gary Zammit, M.D.	New York	New York
United States	Monroe Karetzky, M.D.	Newark	New Jersey
United States	Edward O'Malley	Norwalk	Connecticut
United States	Jorg Pahl, M.D.	Oklahoma City	Oklahoma
United States	William C. Orr, Ph.D.	Oklahoma City	Oklahoma
United States	Stuart Menn, M.D.	Palm Springs	California
United States	Barbara Harris, Ph.D.	Phoenix	Arizona
United States	Lee Brooks, M.D.	Princeton	New Jersey
United States	Judith Owens, M.D., MPH	Providence	Rhode Island
United States	William Torch, M.D., MS	Reno	Nevada
United States	Lawrence Sher, M.D.	Rolling Hills Estates	California
United States	James M. Ferguson, M.D.	Salt Lake City	Utah
United States	Radiant Research, Salt Lake City	Salt Lake City	Utah
United States	Jerry J. Tomasovic, M.D.	San Antonio	Texas
United States	Milton K. Erman, M.D.	San Diego	California
United States	Joel Greenberg	Savannah	Georgia
United States	Robert J. Reichler	Seattle	Washington
United States	Margaret Ann Springer, M.D.	Shreveport	Louisiana
United States	Jed Black, M.D.	Stanford	California
United States	Robert M. Cohen	Stockbridge	Georgia
United States	Michael Neeb, Ph.D.	Toledo	Ohio
United States	Ramalinga Reddy	Toledo	Ohio
United States	William Leeds, D.O.	Topeka	Kansas
United States	Marc Seelagy, M.D.	Trenton	New Jersey
United States	Derek Loewy, Ph.D.	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, when administered for up to 12 months.
Secondary	The secondary objective of the study is to evaluate long-term effectiveness by using: the Clinical Global Impression of Change (CGI C) ratings for severity of ES and the total score from the Pediatric Daytime Sleepiness Scale (PDSS)