EpilepsyPhase 4NCT00137709
Hormone Profiles in Adults With Newly Diagnosed Epilepsy
A Phase 4 study testing Sodium valproate and Lamotrigine in people with Epilepsy, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Sodium valproate and Lamotrigine
- How many people
- 80 participants
- Where
- 2 sitesHong Kong
- Study dates
- Nov 2004to Jul 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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epilepsy requiring antiepileptic drug treatment; or patients previously treated with antiepileptic drugs but have withdrawn from medication for at least 1 year, and now require resumption of antiepileptic drug therapy due to seizure relapse.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 2 recruiting
- Recruiting
United Christian Hospital
Kowloon
Ping Wing Ng, FHKAM
Ping Wing Ng, FHKAM
- Recruiting
Prince of Wales Hospital
Shatin
Patrick Kwan, FHKAM, 852-2632-2211, patrickkwan@cuhk.edu.hk
Evelyn Yu, MSc, 852-2632-3856, evelyn.yu@cuhk.edu.hk
About this study
Official title: Hormone Profiles in Adults Treated With Valproate vs. Lamotrigine Monotherapy for Newly Diagnosed Epilepsy: A Prospective Randomised Study
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Sodium valproate, Lamotrigine
- Keywords
- epilepsy, hormone
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium valproateDrug
Week 1 \& 2 - 200mg twice daily Week 3 onwards - 400mg twice daily
LamotrigineDrug
Week 1 - 25mg mane Week 2 - 25mg twice daily Week 3 - 25mg mane, 50mg nocte Week 4 onwards - 50mg twice daily
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting insulin/glucose ratio
Measured: 12 months
Secondary outcomes (5)
Number of subjects with above normal upper limit(s) of: insulin level
Measured: 12 months
testosterone
Measured: 12 months
low-density lipoprotein (LDL) cholesterol
Measured: 12 months
luteinizing hormone (LH)/follicle stimulating hormone (FSH) ratio
Measured: 12 months
dehydroepiandrosterone (DHEA)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startNov 2004
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Patrick Kwan, FHKAM, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137709
- Sponsor's protocol ID
- CRE-2004.399
- Status last verified
- Oct 2007
- First submitted
- 29 Aug 2005
- Last updated
- 31 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone Profiles in Adults Treated With Valproate vs. Lamotrigine Monotherapy for Newly Diagnosed Epilepsy: A Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT00137709
- Acronym / sponsor ID
- CRE-2004.399
- Conditions
- Epilepsy
- Keywords
- epilepsy, hormone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2004
- Study completion
- Jul 2008 (estimated)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium valproateWeek 1 \& 2 - 200mg twice daily Week 3 onwards - 400mg twice daily | Drug | – |
| LamotrigineWeek 1 - 25mg mane Week 2 - 25mg twice daily Week 3 - 25mg mane, 50mg nocte Week 4 onwards - 50mg twice daily | Drug | – |
Primary outcome
Fasting insulin/glucose ratio
Time frame: 12 months
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Kwan, FHKAM principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium valproate and Lamotrigine in people with Epilepsy, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Kwan, FHKAM (852-2632-2211, patrickkwan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting insulin/glucose ratio (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2007.