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 a small molecule being developed for excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and attention deficit hyperactivity disorder (ADHD). It is being studied in pediatric patients aged 6 years and older. The drug is currently in Phase 3 clinical development.
Who makes Modafinil?
Modafinil is being developed by Teva Pharmaceutical Industries Limited, traded on the stock exchange under the ticker TEVA. The company is conducting Phase 3 clinical trials for the drug in the United States and Canada.
What phase is Modafinil in?
Modafinil is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All four completed clinical trials for the drug were Phase 3 studies.
What clinical trials is Modafinil in?
Modafinil has completed four Phase 3 clinical trials. These include NCT00107796 and NCT00107848 for narcolepsy, NCT00107809 for obstructive sleep apnea, and NCT00214968 for narcolepsy. All trials enrolled children and adolescents aged 6 years and older.
Is Modafinil the same as PROVIGIL?
Yes, Modafinil is the same as PROVIGIL. The clinical trials for the drug are titled 'Study of PROVIGIL (Modafinil) Treatment' and 'PROVIGIL (Modafinil) Treatment' in children and adolescents with excessive sleepiness.