- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00214968
Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness
May 23, 2012 updated by: Cephalon
A 6-Month Open Label, Flexible-Dosage Study to Assess the Safety and Effectiveness of PROVIGIL (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 16 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusions Criteria:
- written informed consent/assent is obtained
- meet minimal criteria established by the International Classification of Sleep Disorders (ICSD) manual of the American Academy of Sleep Medicine (AASM) for narcolepsy (or presumed narcolepsy) or OSAHS OR have a previous diagnosis of narcolepsy or OSAHS before the screening visit
- have a complaint of ES
- are in good health as determined by a medical and psychiatric history, physical examination, ECG, and clinical laboratory tests
- 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 to 16 years
- girls who are postmenarchal or sexually active, have a negative urine pregnancy test at screening, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 2 cycles after participation in the study); acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptives (oral, transdermal, implanted, or injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence
- able to swallow a tablet similar in size and shape to the study drug tablet
- negative urine drug screen (UDS) for any illicit drug, alcohol (ethanol), stimulants at screening; if positive for stimulants (prescribed for excessive sleepiness) at screening, UDS to be repeated after a washout period and before baseline
- have a parent or legal representative 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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Modafinil
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
|
maximum dosage 400 mg/day (4 tablets)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event evaluations
Time Frame: up to 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite Ratings of severity of illness
Time Frame: up to 6 months
|
Clinical global impression (CGI-C) ratings for severity of illness.
The ratings range from 1 to 7; 1 =normal-not at all ill to 7 =among the most extremely ill.
|
up to 6 months
|
Total score from the Pediatric Daytime Sleepiness Scale (PDSS)
Time Frame: up to 6 months
|
A measure of daytime sleepiness and school-related outcomes using PDSS questions: This self-report 8-item questionnaire asks questions with ranges from Always to Never; always being the worst case and never the best case.
|
up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (ACTUAL)
October 1, 2005
Study Completion (ACTUAL)
October 1, 2005
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (ESTIMATE)
September 22, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
May 31, 2012
Last Update Submitted That Met QC Criteria
May 23, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Disorders of Excessive Somnolence
- Sleepiness
- Narcolepsy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
Other Study ID Numbers
- C1538/3034/ES/MN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Narcolepsy
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University of Dublin, Trinity CollegeSt. James's Hospital, IrelandSuspendedNarcolepsy | Hypersomnolence | Narcolepsy Type 1 | Narcolepsy Without Cataplexy | Narcolepsy With Cataplexy | Narcolepsy 1 | Narcolepsy and HypersomniaIreland
-
Northwestern UniversityActive, not recruitingNarcolepsy | Narcolepsy Type 1 | Narcolepsy Without Cataplexy | Narcolepsy With Cataplexy | Narcolepsy Type 2United States
-
Northwestern UniversityNot yet recruitingNightmare | Narcolepsy | Narcolepsy Type 1 | Narcolepsy Without Cataplexy | Narcolepsy With Cataplexy | Nightmare Disorder With Associated Other Sleep Disorder
-
NLS PharmaceuticsCompletedNarcolepsy | Narcolepsy Without Cataplexy | Narcolepsy With CataplexyUnited States
-
Boston Children's HospitalAmerican Academy of Sleep MedicineRecruitingIdiopathic Hypersomnia | Narcolepsy Type 1 | Narcolepsy Type 2United States
-
NLS PharmaceuticsNot yet recruitingNarcolepsy Type 1 | Narcolepsy With Cataplexy
-
TakedaRecruitingNarcolepsy Type 1 | Narcolepsy Type 2Spain, Germany, United States, Italy, Netherlands, Japan, France, Norway, Australia, Finland, Switzerland, Sweden
-
Northwestern UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedNarcolepsy | Narcolepsy Without Cataplexy | Narcolepsy With CataplexyUnited States
-
BioprojetActive, not recruitingNarcolepsy Without Cataplexy | Narcolepsy With CataplexyFrance, Italy, Russian Federation, Finland, Netherlands
-
TakedaTerminatedNarcolepsy Type 1 (NT1) | Narcolepsy Type 2 (NT2)China, United States, Korea, Republic of, France, Italy, Finland, Spain, Czechia, Canada, Japan, Hungary, Netherlands
Clinical Trials on Modafinil
-
The Cooper Health SystemCompletedPostoperative Cognitive Dysfunction
-
Genuine Research Center, EgyptChemipharm Pharmaceutical Industries, EgyptCompleted
-
University of PennsylvaniaNational Institute on Drug Abuse (NIDA)Completed
-
SanofiCompletedBreast Cancer | Prostatic NeoplasmsAustralia
-
Jonsson Comprehensive Cancer CenterCephalonCompletedFatigue | Brain and Central Nervous System Tumors | Cognitive/Functional EffectsUnited States
-
VA Palo Alto Health Care SystemTerminatedInsomnia | Sleep Initiation and Maintenance Disorders | Alzheimer DiseaseUnited States
-
California Pacific Medical Center Research InstituteCompletedMethamphetamine AddictionUnited States
-
California Pacific Medical Center Research InstituteUnknownSubstance Dependence | Amphetamine DependenceUnited States
-
Cephalon, Inc.TerminatedObstructive Sleep Apnea | Narcolepsy | Shift Work Sleep DisorderUnited States