Hormone Profiles in Adults With Newly Diagnosed Epilepsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00137709
First received: August 29, 2005
Last updated: October 30, 2007
Last verified: October 2007
  Purpose

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
Epilepsy
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.

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137709

Contacts
Contact: Patrick Kwan, FHKAM 852-2632-2211 patrickkwan@cuhk.edu.hk
Contact: Evelyn Yu, MSc 852-2632-3856 evelyn.yu@cuhk.edu.hk

Locations
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    patrickkwan@cuhk.edu.hk   
Contact: Evelyn Yu, MSc    852-2632-3856    evelyn.yu@cuhk.edu.hk   
Principal Investigator: Patrick Kwan, FHKAM         
Sub-Investigator: Howan Leung, MRCP         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Patrick Kwan, FHKAM Chinese University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00137709     History of Changes
Other Study ID Numbers: CRE-2004.399
Study First Received: August 29, 2005
Last Updated: October 30, 2007
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
epilepsy
hormone

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Lamotrigine
Valproic Acid
Anticonvulsants
Antimanic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sodium Channel Blockers
Therapeutic Uses
Tranquilizing Agents
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 21, 2014