Late Onset EpilepsyEPITEPNCT05831371
Discard the Curative Causes of Late Onset Epilepsy: the Role of Brain 18F-FDG PET
An observational study of Late Onset Epilepsy and Alzheimer Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Etiology and cognitive prognosis in late onset epilepsy differ from young adults epilepsy. At the epilepsy onset, this is crucial to detect potential curative/treatable brain disorders. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Late Onset Epilepsy, Alzheimer Disease
- What is being tested?
- TEP FDG
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2023to 2 Sep 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: non lesional late onset epilepsy
Who may be able to join
- late onset épilepsy patients without lesion
- epilepsy followed at the CHRU Nancy france
Who cannot join
- epilepsy explained by cortical lesion
- severe psychiatric disorders
- severe addiction (alcool, drugs)
- no FDG TEP performed
- no neuropsychological assessement after 2 years epilepsy onset
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU Nancy
Nancy, 54000
Louise TYVAERT, 0678336090, louise_tyvaert@hotmail.com
About this study
Etiology and cognitive prognosis in late onset epilepsy differ from young adults epilepsy. At the epilepsy onset, this is crucial to detect potential curative/treatable brain disorders. After classical investigation including morphological brain imaging, EEG, clinical assessment, which added value may have brain FDG PET in the diagnosis and prognosis evaluation?
- Conditions
- Late Onset Epilepsy, Alzheimer Disease
- Being tested
- TEP FDG
- Keywords
- FDG PET, cognitive prognosis
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEP FDGDiagnostic test
FDG TEP peformed in clinical routine
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic performances
sensibility, specificty, accurracy
Measured: 2 years after epilepsy onset
Secondary outcomes (1)
cognitive prognosis performances
sensibility, specificty, accurracy
Measured: 2 years after epilepsy onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start2 May 2023 (estimated)
- Primary completion2 Aug 2023 (estimated)
- Study completion2 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Onset EpilepsyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TYVAERT Louise, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831371
- Sponsor's protocol ID
- 2023PI065
- Acronym
- EPITEP
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discard the Curative Causes of Late Onset Epilepsy: the Role of Brain 18F-FDG PET
- ClinicalTrials.gov ID
- NCT05831371
- Acronym / sponsor ID
- EPITEP / 2023PI065
- Conditions
- Late Onset Epilepsy, Alzheimer Disease
- Keywords
- FDG PET, cognitive prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 May 2023 (estimated)
- Primary completion
- 2 Aug 2023 (estimated)
- Study completion
- 2 Sep 2023 (estimated)
- First posted
- 26 Apr 2023 (actual)
- 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.
Etiology and cognitive prognosis in late onset epilepsy differ from young adults epilepsy. At the epilepsy onset, this is crucial to detect potential curative/treatable brain disorders. After classical investigation including morphological brain imaging, EEG, clinical assessment, which added value may have brain FDG PET in the diagnosis and prognosis evaluation?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non lesional late onset epilepsy
Key inclusion criteria (2 listed)
- late onset épilepsy patients without lesion
- epilepsy followed at the CHRU Nancy france
Key exclusion criteria (5 listed)
- epilepsy explained by cortical lesion
- severe psychiatric disorders
- severe addiction (alcool, drugs)
- no FDG TEP performed
- no neuropsychological assessement after 2 years epilepsy onset
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 |
|---|---|---|
| TEP FDGFDG TEP peformed in clinical routine | Diagnostic test | – |
Primary outcome
diagnostic performances
Time frame: 2 years after epilepsy onset
sensibility, specificty, accurracy
1 secondary outcome
cognitive prognosis performances
Time frame: 2 years after epilepsy onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Late Onset Epilepsy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment
Epilepsy, Seizure
RecruitingObservational study
Neurofrailty: A Study of Late-onset Epilepsy and Its Associations
Late Onset Epilepsy, Stroke
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.
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 Late Onset Epilepsy and Alzheimer Disease, run by Central Hospital, Nancy, France at 1 site in France.
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 5 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 26 Apr 2023. 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic performances (time frame: 2 years after epilepsy onset). 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 26 Apr 2023.