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.

• Register: EUCTR
• Last refreshed on: 27 July 2020
• Main ID: EUCTR2004-002505-74-GB
• Date of registration: 10/02/2005
• Prospective Registration: Yes
• Primary sponsor: Cephalon Europe, A Division of Cephalon UK Limited
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 15/02/2005
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002505-74
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Czech Republic, Finland, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
(a) written informed consent/assent is obtained
(b) a boy or girl aged 6 to 16 years, inclusive
(c) meet the 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 OSAHSORhave a previous diagnosis of narcolepsy or OSAHS within 2 years of the screening visit
(d) have a complaint of ES
(e) are in good health as determined by a medical and psychiatric history, physical examination, ECG, and clinical laboratory tests
(f) 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
(g) girls who are postmenarche 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
(h) able to swallow a tablet similar in size and shape to the study drug tablet
(i) 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
(j) have a parent or legal representative who is willing to participate in the study
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
(a) have self-induced sleep deprivation/poor sleep hygiene
(b) 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
(c) have a history of suicide attempt, or are at suicidal risk
(d) a clinically significant drug sensitivity to stimulants such as amfetamine, dexamfetamine, or methylphenidate; and/or modafinil or any of its components
(e) 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 if the patient has been on a stable dose for at least 1 month.)
(f) received any investigational drug (except modafinil) within 4 weeks of the baseline visit
(g) any disorder that could interfere with drug absorption, distribution, metabolism, or excretion (including previous gastrointestinal surgery)
(h) active, clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other major clinically significant disorder/disease
(i) 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
(j) 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.)
(k) seated pulse outside the range of 60 to 115 bpm after resting for 5 minutes
(l) a history of alcohol, narcotic, or any other substance abuse or dependence as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM-IV) criteria
(m) a total daily intake of more than 500 mg of caffeine per day (eg, approximately ten 330-mL cans of caffeinated soft drinks, 5 cups of coffee or tea, or about 750 g of chocolate per day) within 1 week of the baseline visit
(n) pregnant or lactating/nursing girl; any girl who becomes pregnant during the study will be withdrawn
(o) a clinically significant illness within 4 weeks of the baseline visit; or is symptomatic for any clinically significant illness at the baseline visit


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Excessive sleepiness associated with Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome.
MedDRA version: 7.0 Level: LLT Classification code 10015595

Intervention(s)

Trade Name: Provigil
Product Name: Provigil
Product Code: CEP 1538
Pharmaceutical Form: Tablet
INN or Proposed INN: Modafinil
Current Sponsor code: CEP 1538
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: To evaluate the safety and tolerability of treatment with Provigil in children and adolescents with excessive sleepiness (ES) associates with narcolepsy or obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to 6 months.

Secondary Objective: To evaluate the long term effectiveness of Provigil in children and adolescents with excessive sleepiness (ES) associates with narcolepsy or obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to 6 months.

Primary end point(s): Safety:
- clinical laboratory tests at all postbaseline visits
- physical examinations at months 3, and 6, or early termination
- vital signs at all postbaseline visits
- body weight and height (using a height measuring stick) at all monthly visits (months 1 – 6)
- 12-lead ECGs at months 3, and 6, or early termination
- CBCL/6-18 at months 3, and 6, or early termination

Efficacy:
- the CGI-S ratings (for severity of ES) at months 3,and 6, or last postbaseline observation
- the PDSS at months 3, and 6, or last postbaseline observation

Secondary ID(s)

CEP1538/3034/ES/MN

2004-002505-74-CZ

Ethics review

Status: Approved
Approval date: 15/02/2005
Contact: