EpilepsyNCT01231646
Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?
An observational study of Epilepsy and Psychiatric or Mood Diseases or Conditions, run by Northwell Health at 1 site in United States.
Trial summary
Women who take folate (folic acid) before getting pregnant can lower the risk of giving birth to infant with certain birth defects. However, some medications may affect the action of folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on how folate works in our body. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Epilepsy, Psychiatric or Mood Diseases or Conditions
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jul 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients in epilepsy and/or psychiatric clinics
Who may be able to join
- Women ages 18-50 years inclusive who are taking valproate or lamotrigine for neurologic or psychiatric conditions
- Valproate of lamotrigine must be used as monotherapy at stable doses for 6 weeks prior to the study for the neurologic or psychiatric illness; medications taken for other reasons are not excluded.
Who cannot join
- Women with prior exposure to valproate or lamotrigine if they are taking lamotrigine or valproate respectively.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore Long Island Jewish Health System
Great Neck, New York, 11021
About this study
Women who take folate (folic acid) before getting pregnant can lower the risk of giving birth to infant with certain birth defects. However, some medications may affect the action of folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on how folate works in our body.
- Being tested
- No intervention
- Keywords
- Folate Receptor Autoantibodies, Epilepsy, Psychiatric conditions
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention. This is a cross-sectional study.
| Study group | Role | What they receive |
|---|---|---|
| Lamotrigine | No intervention Receives: Other: No intervention | |
| Valproate | No intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Folate Receptor Autoantibodies
ELISA assays using immobilized folate receptor protein were performed to determine the titers of immunoglobulin G, immunoglobulin M, and combined immunoglobulin G and immunoglobulin M to folate receptor in serum samples collected from both groups of women.
Measured: On the same day after informed consent was obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Epilepsy Foundation
- Responsible party
- Sponsor
- Investigators
- Cynthia Harden, MD, Principal investigator, North Shore-Long Island Jewish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231646
- Sponsor's protocol ID
- 10-266A
- Status last verified
- Oct 2015
- First submitted
- 28 Oct 2010
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?
- ClinicalTrials.gov ID
- NCT01231646
- Acronym / sponsor ID
- 10-266A
- Keywords
- Folate Receptor Autoantibodies, Epilepsy, Psychiatric conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Epilepsy Foundation
- Study start
- Oct 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Posted 23 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women who take folate (folic acid) before getting pregnant can lower the risk of giving birth to infant with certain birth defects. However, some medications may affect the action of folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on how folate works in our body.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamotrigine | – | Other: No interventionNo intervention |
| Valproate | – | Other: No interventionNo intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients in epilepsy and/or psychiatric clinics
Key inclusion criteria (2 listed)
- Women ages 18-50 years inclusive who are taking valproate or lamotrigine for neurologic or psychiatric conditions
- Valproate of lamotrigine must be used as monotherapy at stable doses for 6 weeks prior to the study for the neurologic or psychiatric illness; medications taken for other reasons are not excluded.
Key exclusion criteria (1 listed)
- Women with prior exposure to valproate or lamotrigine if they are taking lamotrigine or valproate respectively.
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 |
|---|---|---|
| No interventionNo intervention. This is a cross-sectional study. | Other | Lamotrigine, Valproate |
Primary outcome
Levels of Folate Receptor Autoantibodies
Time frame: On the same day after informed consent was obtained
ELISA assays using immobilized folate receptor protein were performed to determine the titers of immunoglobulin G, immunoglobulin M, and combined immunoglobulin G and immunoglobulin M to folate receptor in serum samples collected from both groups of women.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Cynthia Harden, MD principal investigator
North Shore-Long Island Jewish 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 and Psychiatric or Mood Diseases or Conditions, run by Northwell Health 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 2 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 20 Nov 2015. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Levels of Folate Receptor Autoantibodies (time frame: On the same day after informed consent was obtained). 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 20 Nov 2015.