AutismNCT01097720
Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine,Sodium Valproate, or Carbamazepine
An observational study of Autism and Developmental Delay, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is investigating the neurodevelopmental effects of prenatal exposure to lamotrigine (LTG), sodium valproate (VPA), or carbamazepine (CBZ) monotherapies. The hypotheses to be tested include: 1. Read more about this study
- Who is it for?
- Ages 36 to 83 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism, Developmental Delay, Birth Defects
- How many people
- 298 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Sep 2010
- 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 36 to 83 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children 36-83 months of age, prenatally exposed to LTG, VPA, or CBZ monotherapies, recruited through mothers enrolled in the North American Antiepileptic Drug Pregnancy Registry.
Who may be able to join
- 36-83 months of age
- Prenatal exposure to LTG, VPA, or CBZ monotherapy
- AED was used by mother to suppress seizures
- Mother was enrolled in the North American AED Pregnancy Registry
Who cannot join
- Exposure during the first trimester to other known teratogens.
- Mother with mental health issues
- Refusal to release medical records to confirm eligibility.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine, Sodium Valproate, or Carbamazepine
This study is investigating the neurodevelopmental effects of prenatal exposure to lamotrigine (LTG), sodium valproate (VPA), or carbamazepine (CBZ) monotherapies. The hypotheses to be tested include:
- Exposure during pregnancy to CBZ, LTG, and VPA, each as monotherapy, is associated with developmental delay with or without signs of autism.
- Exposure to each drug (CBZ, LTG, and VPA) as monotherapy is associated with an increased rate of occurrence of major malformations.
- The child with major malformations is more likely to have developmental delay with or without signs of autism than the child who does not have major malformations.
- The occurrence of adaptive behavior outcomes will show a dose-response relationship with the dose of medication taken by the mother in the first trimester.
The study population includes children 36-83 months of age who were exposed throughout gestation to one of the three drugs of interest, as treatment for maternal seizure disorder.
- Conditions
- Autism, Developmental Delay, Birth Defects
- Keywords
- Valproate, Lamotrigine, Carbamazepine, Anticonvulsant, Antiepileptic, Teratogen, Autism, Developmental Delay
- Medical subject headings
- Autistic Disorder, Learning Disabilities, Congenital Abnormalities
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 |
|---|---|---|
| LTG-exposed | Children exposed to LTG during pregnancy. | |
| VPA-exposed | Children exposed to VPA during pregnancy. | |
| CBZ-exposed | Children exposed to CBZ during pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptive Behavior Scores
Measures of each child's Adaptive Behavior scores as assessed by the Vineland-II Adaptive Behavior Scales, collected when the child was between 36 and 83 months of age.
Measured: 36-83 months of age
Secondary outcomes (1)
Presence/Absence of Major Malformations
Based on interview with mother and review of medical records, determination is made as to whether or not the child had any major malformations at birth.
Measured: 36-83 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startMar 2005
- Primary completionJan 2010
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Lewis B. Holmes, MD, Principal investigator, Massachusetts General HospitalJane Adams, Ph.D., Study director, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097720
- Sponsor's protocol ID
- 2005P000379
- Status last verified
- Mar 2010
- First submitted
- 31 Mar 2010
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine, Sodium Valproate, or Carbamazepine
- ClinicalTrials.gov ID
- NCT01097720
- Acronym / sponsor ID
- 2005P000379
- Conditions
- Autism, Developmental Delay, Birth Defects
- Keywords
- Valproate, Lamotrigine, Carbamazepine, Anticonvulsant, Antiepileptic, Teratogen, Autism, Developmental Delay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Sep 2010 (estimated)
- First posted
- 2 Apr 2010 (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.
This study is investigating the neurodevelopmental effects of prenatal exposure to lamotrigine (LTG), sodium valproate (VPA), or carbamazepine (CBZ) monotherapies. The hypotheses to be tested include:
- Exposure during pregnancy to CBZ, LTG, and VPA, each as monotherapy, is associated with developmental delay with or without signs of autism.
- Exposure to each drug (CBZ, LTG, and VPA) as monotherapy is associated with an increased rate of occurrence of major malformations.
- The child with major malformations is more likely to have developmental delay with or without signs of autism than the child who does not have major malformations.
- The occurrence of adaptive behavior outcomes will show a dose-response relationship with the dose of medication taken by the mother in the first trimester.
The study population includes children 36-83 months of age who were exposed throughout gestation to one of the three drugs of interest, as treatment for maternal seizure disorder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LTG-exposed | – | –Children exposed to LTG during pregnancy. |
| VPA-exposed | – | –Children exposed to VPA during pregnancy. |
| CBZ-exposed | – | –Children exposed to CBZ during pregnancy. |
Who may qualify
- Ages
- 36 to 83 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children 36-83 months of age, prenatally exposed to LTG, VPA, or CBZ monotherapies, recruited through mothers enrolled in the North American Antiepileptic Drug Pregnancy Registry.
Key inclusion criteria (4 listed)
- 36-83 months of age
- Prenatal exposure to LTG, VPA, or CBZ monotherapy
- AED was used by mother to suppress seizures
- Mother was enrolled in the North American AED Pregnancy Registry
Key exclusion criteria (3 listed)
- Exposure during the first trimester to other known teratogens.
- Mother with mental health issues
- Refusal to release medical records to confirm eligibility.
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
Adaptive Behavior Scores
Time frame: 36-83 months of age
Measures of each child's Adaptive Behavior scores as assessed by the Vineland-II Adaptive Behavior Scales, collected when the child was between 36 and 83 months of age.
1 secondary outcome
Presence/Absence of Major Malformations
Time frame: 36-83 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2010.
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Lewis B. Holmes, MD principal investigator
Massachusetts General Hospital
Jane Adams, Ph.D. study director
University of Massachusetts, Boston
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 Autism and Developmental Delay, run by Massachusetts General Hospital 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 4 inclusion and 3 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 2 Apr 2010. 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?
Results are not available in the source record.
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?
Adaptive Behavior Scores (time frame: 36-83 months of age). 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 2 Apr 2010.