Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137709
Status:
UNKNOWN
Last Update Posted:
2007-10-31
First Post:
2005-08-29
Brief Title:
Hormone Profiles in Adults With Newly Diagnosed Epilepsy
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Hormone Profiles in Adults Treated With Valproate vs Lamotrigine Monotherapy for Newly Diagnosed Epilepsy A Prospective Randomised Study
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Both sodium valproate and lamotrigine are currently used in the treatment of newly diagnosed epilepsy Although they appear to have similar efficacy they have different side effects which have not been well studied This study aims to compare one particular aspect of their possible side effects namely whether they affect certain hormonal functions
Detailed Description:
Sodium valproate is an established antiepileptic drug used against a broad range of seizure types Lamotrigine a newer antiepileptic drug available since late 1980s has a similar range of action and is approved as first-line treatment for epilepsy in the United States and many European countries as well as in Hong Kong Recently concern has been raised over the association between valproate treatment and polycystic ovarian syndrome a condition characterised by multiple cysts in the ovaries in women and a range of hormonal and metabolic disturbances Cross-sectional studies from Finland suggest that up to 40 of women treated with valproate have polycystic ovaries Lamotrigine substitution for valproate has been reported to normalise these parameters in some patients Elevated serum insulin and androgen levels have also been reported in over 50 of male patients taking valproate for epilepsy However such high incidence of hormonal abnormalities associated with valproate treatment has not been reproduced in studies conducted in other western populations No similar studies in Chinese patients have been reported In addition these cross-sectional studies suffer from many potential confounding factors such as previous treatment with other antiepileptic drugs variation in duration of treatment thus limiting the ability to establish a causal relationship
This phase IV study aims to examine whether valproate treatment is associated with hormonal abnormalities in Chinese epilepsy patients Newly diagnosed patients will be randomised to receive valproate or lamotrigine and their hormonal profiles measured prospectively for 12 months
This phase IV study aims to examine whether valproate treatment is associated with hormonal abnormalities in Chinese epilepsy patients Newly diagnosed patients will be randomised to receive valproate or lamotrigine and their hormonal profiles measured prospectively for 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None