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Hormone Profiles in Adults With Newly Diagnosed Epilepsy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Chinese University of Hong Kong.
Recruitment status was:  Recruiting
Information provided by:
Chinese University of Hong Kong Identifier:
First received: August 29, 2005
Last updated: October 30, 2007
Last verified: October 2007
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.

Condition Intervention Phase
Drug: Sodium valproate
Drug: Lamotrigine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hormone Profiles in Adults Treated With Valproate vs. Lamotrigine Monotherapy for Newly Diagnosed Epilepsy: A Prospective Randomised Study

Resource links provided by NLM:

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Fasting insulin/glucose ratio [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Number of subjects with above normal upper limit(s) of: insulin level [ Time Frame: 12 months ]
  • testosterone [ Time Frame: 12 months ]
  • low-density lipoprotein (LDL) cholesterol [ Time Frame: 12 months ]
  • luteinizing hormone (LH)/follicle stimulating hormone (FSH) ratio [ Time Frame: 12 months ]
  • dehydroepiandrosterone (DHEA) [ Time Frame: 12 months ]

Estimated Enrollment: 80
Study Start Date: November 2004
Estimated Study Completion Date: July 2008
Intervention Details:
    Drug: Sodium valproate
    Week 1 & 2 - 200mg twice daily Week 3 onwards - 400mg twice daily
    Drug: Lamotrigine
    Week 1 - 25mg mane Week 2 - 25mg twice daily Week 3 - 25mg mane, 50mg nocte Week 4 onwards - 50mg twice daily
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.


Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00137709

Contact: Patrick Kwan, FHKAM 852-2632-2211
Contact: Evelyn Yu, MSc 852-2632-3856

Hong Kong
United Christian Hospital Recruiting
Kowloon, Hong Kong
Contact: Ping Wing Ng, FHKAM         
Principal Investigator: Ping Wing Ng, FHKAM         
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Patrick Kwan, FHKAM    852-2632-2211   
Contact: Evelyn Yu, MSc    852-2632-3856   
Principal Investigator: Patrick Kwan, FHKAM         
Sub-Investigator: Howan Leung, MRCP         
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Patrick Kwan, FHKAM Chinese University of Hong Kong
  More Information Identifier: NCT00137709     History of Changes
Other Study ID Numbers: CRE-2004.399
Study First Received: August 29, 2005
Last Updated: October 30, 2007

Keywords provided by Chinese University of Hong Kong:

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers processed this record on April 25, 2017