NCT00107848PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea SyndromeNarcolepsy
NCT00343811Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil TreatmentAttention Deficit Hyperactivity Disorder
NCT00107809Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea SyndromeSleep Apnea, Obstructive
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
Mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps performed at 0900, 1100, 1300, and 1500) at the last post baseline observation (week 6 or early termination)
The Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post baseline observation (week 6 or early termination)
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.
Evaluate the safety of treatment with the modafinil film coated tablet.
Adverse event evaluations
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
Secondary Endpoints
Clinical Global Impression of Change (CGI-C) ratings for ES at weeks 3 and 6
Total score from the Pediatric Daytime Sleepiness Scale (PDSS) at weeks 3 and 6, and last postbaseline observation
Mean sleep latency from the MSLT (average of 4 naps performed at 0900, 1100, 1300, and 1500) at week 6
Inclusion Criteria:
Patients are included in the study if all of the following criteria are met:
* Written informed consent/assent is obtained.
* The patient is a boy or girl 6 through 17 years of age (inclusive) at the screening visit, and both the patient and parent/legal guardian are English-sp...
Modafinil is being studied for use in obstructive sleep apnea, attention deficit hyperactivity disorder (ADHD), and narcolepsy. It is an investigational small molecule in Phase 3 clinical development for these psychiatric and sleep-related conditions.
Who makes Modafinil?
Modafinil is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with ADHD and other conditions.
What phase is Modafinil in?
Modafinil is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for the conditions being studied.
What clinical trials is Modafinil in?
Modafinil has completed several clinical trials, including NCT00214981 and NCT00228540, which evaluated its use in children and adolescents with ADHD. NCT00315276 was a dose-finding study in adults with ADHD, and NCT00343811 assessed efficacy in ADHD patients who responded to treatment.
Is Modafinil the same as Provigil?
Modafinil is the generic name for the drug also known as Provigil. It is being studied for conditions such as ADHD, narcolepsy, and obstructive sleep apnea, and is currently in Phase 3 development by Teva Pharmaceutical Industries.