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
Active, not recruiting
- Conditions
- Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea SyndromeMedDRA version: 6.1Level: HLGTClassification code 10040998
- Registration Number
- EUCTR2004-002505-74-IT
- Lead Sponsor
- CEPHALON EUROPE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of modafinil improve excessive sleepiness in pediatric narcolepsy and OSAHS patients?
How does modafinil compare to traditional stimulants like amphetamines in treating pediatric excessive sleepiness?
Are there specific biomarkers that predict modafinil response in children with narcolepsy or OSAHS?
What are the long-term adverse events associated with modafinil use in adolescents with sleep disorders?
What are the current combination therapies involving modafinil for pediatric narcolepsy and OSAHS compared to CEPHALON EUROPE's trial?