Hormone Profiles in Adults With Newly Diagnosed Epilepsy
Hormone Profiles in Adults Treated With Valproate vs. Lamotrigine Monotherapy for Newly Diagnosed Epilepsy: A Prospective Randomised Study
1 other identifier
interventional
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2004
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedOctober 31, 2007
October 1, 2007
August 29, 2005
October 30, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasting insulin/glucose ratio
12 months
Secondary Outcomes (5)
Number of subjects with above normal upper limit(s) of: insulin level
12 months
testosterone
12 months
low-density lipoprotein (LDL) cholesterol
12 months
luteinizing hormone (LH)/follicle stimulating hormone (FSH) ratio
12 months
dehydroepiandrosterone (DHEA)
12 months
Interventions
Week 1 \& 2 - 200mg twice daily Week 3 onwards - 400mg twice daily
Week 1 - 25mg mane Week 2 - 25mg twice daily Week 3 - 25mg mane, 50mg nocte Week 4 onwards - 50mg twice daily
Eligibility Criteria
You may qualify if:
- Patients aged between 15 and 55
- Ethnically Chinese
- Newly diagnosed epilepsy requiring antiepileptic drug treatment; or patients previously treated with antiepileptic drugs but have withdrawn from medication for at least 1 year, and now require resumption of antiepileptic drug therapy due to seizure relapse.
You may not qualify if:
- Post-menopausal women.
- Pregnant women.
- Women who have undergone oophorectomy.
- Women taking or have taken oral contraceptive pills in the previous 3 months.
- Women diagnosed with or suspected to have polycystic ovarian syndrome.
- Subjects with diabetes mellitus.
- Subjects receiving hormone replacement or glucocorticoids.
- Subjects receiving long-term warfarin.
- Subjects suffering from significant systemic diseases, or illnesses that interfere with pituitary-gonadal functions.
- Subjects with a progressive or degenerative neurological disorder.
- Subjects who are unable to take their medication reliably.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
United Christian Hospital
Kowloon, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Kwan, FHKAM
Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 29, 2005
First Posted
August 30, 2005
Study Start
November 1, 2004
Study Completion
July 1, 2008
Last Updated
October 31, 2007
Record last verified: 2007-10