The use of modafinil (Provigil) in the treatment of hyperphagia in children with hypothalamic obesity
DEC-NET Serial number GB293
Published online16/07/2004 16.22.00
Last updated02/08/2005 14.27.25
Other protocol ID numberN0012128196
This trial has been approved by an ethics committee
Current trial status
Major Disease
(ICD9 class)		OBESITY NOS
Experimental drug
modafinil
GenderBoth
Age (range)2 -11 years

Eligibility criteria
Inclusion criteria
children with hypothalamic obesity
Exclusion criteria
Informed consent not given

Trial design/methodology
Phase3
Kind of studyEfficacy
DesignCasenote review.
Purpose of study
One of the listed adverse effects of modafinil is anorexia. How effective is modafinil in the treatment of obesity in children with hypothalamic damage?
Primary outcomes
Rate of weight loss and sleep/wake cycle recovery
Summary of study design, objectives, and ongoing research findings
Casenote review to determine how effective modafinil is in the treatment of obesity in children with hypothalamic damage.
Principal investigator
NameDr R Stanhope
InstitutionInstitute of Child Health
Postal addressBiochemistry, Endocrinology & Metabolism Unit, Institute of Child Health, 30 Guilford Street, London, WC1N 1EH
CityLondon
CountryUNITED KINGDOM
Phone020 7405 9200 Ext 2139/5469
Fax020 7813 8496
E-mailR.Stanhope@ich.ucl.ac.uk


Sponsor name
(No funding) ((No funding))

ISRCTN  EudraCT