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A review of modafinil film-coated tablets for attention-deficit/hyperactivity disorder in children and adolescents.

Rugino T - Neuropsychiatr Dis Treat (2007)

Bottom Line: Several studies, including three double-blind, placebo-controlled studies with intent-to-treat analyses, have demonstrated the efficacy of modafinil film-coated tablets in reducing symptoms of ADHD and associated problem behaviors in children and adolescents.Modafinil is generally well tolerated, with adverse events (such as insomnia, headache, loss of appetite, weight loss, and gastrointestinal discomfort) that are generally mild to moderate, rarely leading to medication discontinuation.Due to reports of skin rash (including one case of possible erythema multiforme/Stevens Johnson Syndrome during pivotal studies), additional studies have been requested to better evaluate the risks of developing severe cutaneous adverse reactions.

View Article: PubMed Central - PubMed

Affiliation: Children's Specialized Hospital, 94 Stevens Road, Toms River, NJ 08755, USA. trugino@childrens-specialized.org

ABSTRACT
Modafinil, a wakefulness-promoting agent unrelated to classical sympathomimetic stimulants, has been studied in a total of 933 children and adolescents as a treatment for attention-deficit/hyperactivity disorder (ADHD). Several studies, including three double-blind, placebo-controlled studies with intent-to-treat analyses, have demonstrated the efficacy of modafinil film-coated tablets in reducing symptoms of ADHD and associated problem behaviors in children and adolescents. Modafinil is generally well tolerated, with adverse events (such as insomnia, headache, loss of appetite, weight loss, and gastrointestinal discomfort) that are generally mild to moderate, rarely leading to medication discontinuation. To minimize treatment-emergent side effects, titration to the target dose of 355-425 mg once a day should take place over 2-3 weeks. Due to reports of skin rash (including one case of possible erythema multiforme/Stevens Johnson Syndrome during pivotal studies), additional studies have been requested to better evaluate the risks of developing severe cutaneous adverse reactions.

No MeSH data available.


Related in: MedlinePlus

Percentage responders as a function of time for a fixed-dose study of efficacy of modafinil for children and adolescents with attention-deficit/hyperactivity disorder (n = 183). Response is defined as having a Clinical Global Impressions of Change score of 1 (“very much improved”) or 2 (“much improved”). *p values <0.05; EP = endpoint, which represents the last obtained value carried forward. Reproduced from Cephalon, Inc. 2006. Modafinil (CEP-1538) tablets Supplemental NDA 20-717/S-019 ADHD indication. Briefing document for Psychopharmacologic Drugs Advisory Committee Meeting March 26, 2006. Frazer, PA: Cephalon, Inc.
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f4c-ndt-3-293: Percentage responders as a function of time for a fixed-dose study of efficacy of modafinil for children and adolescents with attention-deficit/hyperactivity disorder (n = 183). Response is defined as having a Clinical Global Impressions of Change score of 1 (“very much improved”) or 2 (“much improved”). *p values <0.05; EP = endpoint, which represents the last obtained value carried forward. Reproduced from Cephalon, Inc. 2006. Modafinil (CEP-1538) tablets Supplemental NDA 20-717/S-019 ADHD indication. Briefing document for Psychopharmacologic Drugs Advisory Committee Meeting March 26, 2006. Frazer, PA: Cephalon, Inc.


A review of modafinil film-coated tablets for attention-deficit/hyperactivity disorder in children and adolescents.

Rugino T - Neuropsychiatr Dis Treat (2007)

Percentage responders as a function of time for a fixed-dose study of efficacy of modafinil for children and adolescents with attention-deficit/hyperactivity disorder (n = 183). Response is defined as having a Clinical Global Impressions of Change score of 1 (“very much improved”) or 2 (“much improved”). *p values <0.05; EP = endpoint, which represents the last obtained value carried forward. Reproduced from Cephalon, Inc. 2006. Modafinil (CEP-1538) tablets Supplemental NDA 20-717/S-019 ADHD indication. Briefing document for Psychopharmacologic Drugs Advisory Committee Meeting March 26, 2006. Frazer, PA: Cephalon, Inc.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2654790&req=5

f4c-ndt-3-293: Percentage responders as a function of time for a fixed-dose study of efficacy of modafinil for children and adolescents with attention-deficit/hyperactivity disorder (n = 183). Response is defined as having a Clinical Global Impressions of Change score of 1 (“very much improved”) or 2 (“much improved”). *p values <0.05; EP = endpoint, which represents the last obtained value carried forward. Reproduced from Cephalon, Inc. 2006. Modafinil (CEP-1538) tablets Supplemental NDA 20-717/S-019 ADHD indication. Briefing document for Psychopharmacologic Drugs Advisory Committee Meeting March 26, 2006. Frazer, PA: Cephalon, Inc.
Bottom Line: Several studies, including three double-blind, placebo-controlled studies with intent-to-treat analyses, have demonstrated the efficacy of modafinil film-coated tablets in reducing symptoms of ADHD and associated problem behaviors in children and adolescents.Modafinil is generally well tolerated, with adverse events (such as insomnia, headache, loss of appetite, weight loss, and gastrointestinal discomfort) that are generally mild to moderate, rarely leading to medication discontinuation.Due to reports of skin rash (including one case of possible erythema multiforme/Stevens Johnson Syndrome during pivotal studies), additional studies have been requested to better evaluate the risks of developing severe cutaneous adverse reactions.

View Article: PubMed Central - PubMed

Affiliation: Children's Specialized Hospital, 94 Stevens Road, Toms River, NJ 08755, USA. trugino@childrens-specialized.org

ABSTRACT
Modafinil, a wakefulness-promoting agent unrelated to classical sympathomimetic stimulants, has been studied in a total of 933 children and adolescents as a treatment for attention-deficit/hyperactivity disorder (ADHD). Several studies, including three double-blind, placebo-controlled studies with intent-to-treat analyses, have demonstrated the efficacy of modafinil film-coated tablets in reducing symptoms of ADHD and associated problem behaviors in children and adolescents. Modafinil is generally well tolerated, with adverse events (such as insomnia, headache, loss of appetite, weight loss, and gastrointestinal discomfort) that are generally mild to moderate, rarely leading to medication discontinuation. To minimize treatment-emergent side effects, titration to the target dose of 355-425 mg once a day should take place over 2-3 weeks. Due to reports of skin rash (including one case of possible erythema multiforme/Stevens Johnson Syndrome during pivotal studies), additional studies have been requested to better evaluate the risks of developing severe cutaneous adverse reactions.

No MeSH data available.


Related in: MedlinePlus