EpilepsyNCT00296413
A Study to Look at Antiepileptic Drug Levels While on Lamictal or Depakote With or Without an Oral Contraceptive
An observational study of Epilepsy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Some antiseizure medication levels are affected by hormones. This study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself. Read more about this study
- Who is it for?
- Ages 13 to 45 years, women only
- Conditions the study is for
- Epilepsy
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2009
- Phase
- Observational
- 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 13 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Two regional epilepsy centers
Who may be able to join
- Must be a female between 13-45 years of age
- Must have a history of seizures
- Must be taking either lamotrigine (Lamictal) or valproate (Depakote) with or without a birth control pill
Who cannot join
- Must not be on antidepressant medication, tranquilizers, or other forms of hormonal therapy other than the birth control pill
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Variation of Serum Valproate and Lamotrigine Levels in Relation to The Menstrual Cycle and Oral Contraceptive Use
Some antiseizure medication levels are affected by hormones. This study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself.
Read the detailed description
Participants will be given informed consent and will be asked to have two blood draws at specific times of the menstrual cycle or if on a birth control pill, during the active and inactive pill phases.
- Conditions
- Epilepsy
- Keywords
- epilepsy, menstrual cycle, valproate, lamotrigine, oral contraceptive
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Valproate monotherapy | |
| 2 | Valproate monotherapy with combined oral contraceptive | |
| 3 | Lamotrigine monotherapy | |
| 4 | Lamotrigine monotherapy with combined oral contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
To carry out a controlled investigation to determine if combined oral contraceptive (COC) use affects serum valproate (VPA) and lamotrigine (LTG) levels
Measured: 3 years
To distinguish any apparent COC effects from the potential effects of the naturally occurring high (mid luteal) and low (early follicular, menstrual) steroid phases of the menstrual cycle itself
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionFeb 2009
- Study completionFeb 2009
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 Beth Israel Deaconess Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital
- Responsible party
- Principal investigator, Andrew Herzog, Beth Israel Deaconess Medical Center
- Investigators
- Andrew G. Herzog, M.D., M.Sc., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296413
- Sponsor's protocol ID
- 2005P000379
- Status last verified
- Mar 2017
- First submitted
- 21 Feb 2006
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation of Serum Valproate and Lamotrigine Levels in Relation to The Menstrual Cycle and Oral Contraceptive Use
- ClinicalTrials.gov ID
- NCT00296413
- Acronym / sponsor ID
- 2005P000379
- Conditions
- Epilepsy
- Keywords
- epilepsy, menstrual cycle, valproate, lamotrigine, oral contraceptive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Rhode Island Hospital
- Study start
- Feb 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 Feb 2006 (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.
Some antiseizure medication levels are affected by hormones. This study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself.
Detailed description
Participants will be given informed consent and will be asked to have two blood draws at specific times of the menstrual cycle or if on a birth control pill, during the active and inactive pill phases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Valproate monotherapy |
| 2 | – | –Valproate monotherapy with combined oral contraceptive |
| 3 | – | –Lamotrigine monotherapy |
| 4 | – | –Lamotrigine monotherapy with combined oral contraceptive |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Two regional epilepsy centers
Key inclusion criteria (3 listed)
- Must be a female between 13-45 years of age
- Must have a history of seizures
- Must be taking either lamotrigine (Lamictal) or valproate (Depakote) with or without a birth control pill
Key exclusion criteria (1 listed)
- Must not be on antidepressant medication, tranquilizers, or other forms of hormonal therapy other than the birth control pill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To carry out a controlled investigation to determine if combined oral contraceptive (COC) use affects serum valproate (VPA) and lamotrigine (LTG) levels
Time frame: 3 years
To distinguish any apparent COC effects from the potential effects of the naturally occurring high (mid luteal) and low (early follicular, menstrual) steroid phases of the menstrual cycle itself
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
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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.
Andrew G. Herzog, M.D., M.Sc. principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To carry out a controlled investigation to determine if combined oral contraceptive (COC) use affects serum valproate (VPA) and lamotrigine (LTG) levels (time frame: 3 years). The study lists 2 primary outcomes in all. 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 14 Mar 2017.