Partial EpilepsyNCT00001932
Serotonin Receptors in Seizure Disorders
An observational study of Partial Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Patients in this study will undergo PET scans (a type of nuclear imaging test) to look for abnormalities in certain brain proteins associated with seizures. Studies in animals have shown that serotonin-a chemical messenger produced by the body-attaches to proteins on brain cells called 5HT1A receptors and changes them… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Epilepsy
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 1999to 15 Aug 2007
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients must have clinically documented partial seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, refractory to standard antiepileptic treatment for at least one year.
- Patients will be in age ranges of 18 to 60.
- Patients may be male or female. Female patients of child bearing potential will have a pregnancy test prior to each PET scan to ensure that pregnant patients will not participate in the study. During the study, woman of child bearing potential must use a reliable method of birth control.
- Three groups of patients will be scanned:
- 50 patients with EEG and clinical evidence for mesial temporal onset with either MRI findings of mesial temporal sclerosis (MTS) or dysplasia or normal MRI studies.
- 25 patients with apparent neocortical seizure foci.
- In addition, patients will be screened for the presence of depression in addition to epilepsy; at least 15 patients from groups 1 and 2 who currently meet DSM-IV criteria for the category "Mood disorder due to epilepsy" (293.83), and the subtype "with major Depressive-Like Episode" 296.2 Major Depressive Disorder, Single Episode, or 296.3 Major Depressive Disorder, Recurrent, indicating that subjects meet diagnostic criteria for a major depressive episode. DSM diagnoses will be based on the Research Version of the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I) including the detailed assessment of the course of both epilepsy and depressive symptoms as well as the family history of medical and psychiatric conditions.
- Twenty healthy normal adults will be included. Controls will be screened in the NINDS Clinical Epilepsy Section outpatient clinic, with physical examination, CBC urinalysis and blood chemistries. Controls with chronic illnesses, taking any medications, or who smoke will be excluded. They will be asked to abstain from alcohol for one week before the study.
Who cannot join
- Patients younger than 18 or older than 60 years old will be excluded from the study.
- Patients with a known treatable seizure etiology such as neoplastic or infectious disease will be excluded.
- Patients with MRI findings consistent with brain tumors, trauma or AVMs will be excluded.
- Patients with progressive neurologic disorders.
- Patients with a history of significant medical disorders, or requiring chronic treatment with other drugs which can not be stopped, except for SSRIs.
- Patients with cancer.
- Patients not capable of giving an informed consent.
- Patients who had seizure activity 24 hours prior to the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: PET Imaging of Serotonin Receptors in Seizure Disorders
Patients in this study will undergo PET scans (a type of nuclear imaging test) to look for abnormalities in certain brain proteins associated with seizures.
Studies in animals have shown that serotonin-a chemical messenger produced by the body-attaches to proteins on brain cells called 5HT1A receptors and changes them in some way that may help control seizures. There is little information on these changes, however. A new compound that is highly sensitive to 5HT1A, will be used in PET imaging to measure the level of activity of these receptors and try to detect abnormalities. Changes in receptor activity may help determine where in the brain the seizures are originating.
Read more
Additional PET scans will be done to measure the amount of blood flow to the brain and the rate at which the brain uses glucose-a sugar that is the brain's main fuel. Blood flow measurement is used to calculate the distribution of serotonin receptors, and glucose use helps determine how seizures affect brain function.
The information gained from the study will be used to try to help guide the patient's therapy and determine if surgery might be beneficial in controlling the patient's seizures.
Read the detailed description
Objective: to study serotonin receptors in patients with localization-related epilepsy. Studies in experimental animals have suggested that: Serotonin is an anticonvulsant neurotransmitter in a number of seizure models; its anticonvulsant action is mediated by activation of 5-HT(1A) receptors; drugs with antiepileptic effects may release 5HT or block reuptake, and these mechanisms appear to be related to their therapeutic effect. 5HT(1A) receptors are abundant in regions such as entorhinal cortex, hippocampus, and temporal neocortex, where epileptogenic zones are frequently found. Considerable evidence from literature indicates that alterations in 5-HT(1A) receptors exist in experimental models of both generalized and complex partial seizures. There is little data on changes in 5-HT receptors in epileptic patients.
Study population: 75 patients with localization-related epilepsy and 20 normal controls, aged 18-60.
Design: Using a new PET compound which is a highly selective 5-HT(1A) silent antagonist referred to as (18)FCWAY, we will attempt to detect abnormalities in serotonin receptors in vivo in patients with epilepsy. The patients will have (18)FCWAY serotonin receptor studies (which include (15)H2O-CBF PET) and high resolution T1-weighted MRI for co-registration. (18)FDG-PET will be performed in the patients as part of seizure focus localization. We will also test subjects for the serotonin transporter polymorphism associated with depression, and perform a standard depression battery.
Outcome measures: 5HT-1A receptor binding and Glucose metabolism measured by PET.
- Conditions
- Partial Epilepsy
- Keywords
- Epilepsy, Temporal Lobe, Blood Flow, Metabolism, Localization
- Medical subject headings
- Epilepsies, Partial, Epilepsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start21 Jun 1999
- Study completion15 Aug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial EpilepsyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Enrolment
- 95 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001932
- Sponsor's protocol ID
- 990122
- Other IDs
- 99-N-0122
- Status last verified
- 15 Aug 2007
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Busatto GF. Radioligands for brain 5-HT2 receptor imaging in vivo: why do we need them? Eur J Nucl Med. 1996 Aug;23(8):867-70. doi: 10.1007/BF01084358. No abstract available.
PubMed 8753673
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Serotonin Receptors in Seizure Disorders
- ClinicalTrials.gov ID
- NCT00001932
- Acronym / sponsor ID
- 990122
- Conditions
- Partial Epilepsy
- Keywords
- Epilepsy, Temporal Lobe, Blood Flow, Metabolism, Localization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 21 Jun 1999
- Study completion
- 15 Aug 2007
- First posted
- 4 Nov 1999 (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.
Patients in this study will undergo PET scans (a type of nuclear imaging test) to look for abnormalities in certain brain proteins associated with seizures.
Studies in animals have shown that serotonin-a chemical messenger produced by the body-attaches to proteins on brain cells called 5HT1A receptors and changes them in some way that may help control seizures. There is little information on these changes, however. A new compound that is highly sensitive to 5HT1A, will be used in PET imaging to measure the level of activity of these receptors and try to detect abnormalities. Changes in receptor activity may help determine where in the brain the seizures are originating.
Additional PET scans will be done to measure the amount of blood flow to the brain and the rate at which the brain uses glucose-a sugar that is the brain's main fuel. Blood flow measurement is used to calculate the distribution of serotonin receptors, and glucose use helps determine how seizures affect brain function.
The information gained from the study will be used to try to help guide the patient's therapy and determine if surgery might be beneficial in controlling the patient's seizures.
Detailed description
Objective: to study serotonin receptors in patients with localization-related epilepsy. Studies in experimental animals have suggested that: Serotonin is an anticonvulsant neurotransmitter in a number of seizure models; its anticonvulsant action is mediated by activation of 5-HT(1A) receptors; drugs with antiepileptic effects may release 5HT or block reuptake, and these mechanisms appear to be related to their therapeutic effect. 5HT(1A) receptors are abundant in regions such as entorhinal cortex, hippocampus, and temporal neocortex, where epileptogenic zones are frequently found. Considerable evidence from literature indicates that alterations in 5-HT(1A) receptors exist in experimental models of both generalized and complex partial seizures. There is little data on changes in 5-HT receptors in epileptic patients.
Study population: 75 patients with localization-related epilepsy and 20 normal controls, aged 18-60.
Design: Using a new PET compound which is a highly selective 5-HT(1A) silent antagonist referred to as (18)FCWAY, we will attempt to detect abnormalities in serotonin receptors in vivo in patients with epilepsy. The patients will have (18)FCWAY serotonin receptor studies (which include (15)H2O-CBF PET) and high resolution T1-weighted MRI for co-registration. (18)FDG-PET will be performed in the patients as part of seizure focus localization. We will also test subjects for the serotonin transporter polymorphism associated with depression, and perform a standard depression battery.
Outcome measures: 5HT-1A receptor binding and Glucose metabolism measured by PET.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients must have clinically documented partial seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, refractory to standard antiepileptic treatment for at least one year.
- Patients will be in age ranges of 18 to 60.
- Patients may be male or female. Female patients of child bearing potential will have a pregnancy test prior to each PET scan to ensure that pregnant patients will not participate in the study. During the study, woman of child bearing potential must use a reliable method of birth control.
- 50 patients with EEG and clinical evidence for mesial temporal onset with either MRI findings of mesial temporal sclerosis (MTS) or dysplasia or normal MRI studies.
- 25 patients with apparent neocortical seizure foci.
Key exclusion criteria (8 listed)
- Patients younger than 18 or older than 60 years old will be excluded from the study.
- Patients with a known treatable seizure etiology such as neoplastic or infectious disease will be excluded.
- Patients with MRI findings consistent with brain tumors, trauma or AVMs will be excluded.
- Patients with progressive neurologic disorders.
- Patients with a history of significant medical disorders, or requiring chronic treatment with other drugs which can not be stopped, except for SSRIs.
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 8753673Busatto GF. Radioligands for brain 5-HT2 receptor imaging in vivo: why do we need them? Eur J Nucl Med. 1996 Aug;23(8):867-70. doi: 10.1007/BF01084358. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Partial Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 8 inclusion and 8 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 2 Jul 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001932, which also lists 1 linked publication.
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 Jul 2017.