Sudden Unexpected Death in Epilepsy (SUDEP)SUDEPNCT02788318
Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)
An observational study of Sudden Unexpected Death in Epilepsy (SUDEP), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The mortality rate is increased in patients with epilepsy, and especially among patients with drug-resistant epilepsy. This increased mortality is mainly related to the risk of SUDEP whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Unexpected Death in Epilepsy (SUDEP)
- What is being tested?
- Brain samples and Skin samples
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with epilepsy who died
Who may be able to join
- Age >18 years
- Postmortem time before autopsy <30 hours
Who cannot join
- Age <18 years
- postmortem time before autopsy > 30 hours
- Any subject whose brain would be of forensic interest
- Any patient who expressed an opposition to organ donation.
Trial locations and contacts
1 site in 1 country.
About this study
The mortality rate is increased in patients with epilepsy, and especially among patients with drug-resistant epilepsy. This increased mortality is mainly related to the risk of SUDEP whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant epilepsy. The term SUDEP refers to a sudden death occurring in a patient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause. Experimental and clinical data strongly suggest that most of SUDEP result from a postictal respiratory dysfunction progressing to terminal apnea. Due to the major role of serotonin in regulating breathing rhythms and data in animal models of epilepsy, it is envisaged that an alteration of serotonergic systems of the brainstem and limbic regions may play a central role in the occurrence of SUDEP. The objective of this work is to look for abnormalities of the serotonergic transmission within regulatory regions of respiratory and autonomic functions in brain samples prospectively collected in patients died from SUDEP.
- Being tested
- Brain samples, Skin samples
- Keywords
- Epilepsy, SUDEP, Serotonin
- Medical subject headings
- Sudden Unexpected Death in Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain samplesOther
Collected in patients died
Skin samplesOther
Collected in patients died
| Study group | Role | What they receive |
|---|---|---|
| diagnostic of SUDEP | patient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause (diagnosis of SUDEP). Brain samples and skin samples are collected. Receives: Other: Brain samples; Other: Skin samples | |
| Control 1 | Subjects with a known epilepsy, whose death is linked to a specific cause. Brain samples and skin samples are collected. Receives: Other: Brain samples; Other: Skin samples | |
| Control 2 | Subjects without known pathological history, remained victims of unexplained sudden unexpected death (SUDEP) after all investigations and for which a heart rhythm disorder is suspected in first intention. Brain samples and skin samples are collected. Receives: Other: Brain samples; Other: Skin samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Density of Medullary 5-HT Neurons
5-HT1A receptor binding density in within the medulla
Measured: between 1 to 30 hours following death
Secondary outcomes (3)
Other markers of 5HT within the medulla
Expression of 5HT-1A and 5HT-2 receptors, expression of 5HT transporter, Tryptophan Hydroxylase 2 (TPH2)
Measured: between 1 to 30 hours following death
Serotoninergic pathway in the pons, the hippocampus and the insula
5-HT1A receptor binding density, Expression of 5HT-1A and 5HT-2 receptors, expression of 5HT transporter, Tryptophan Hydroxylase 2 (TPH2)
Measured: between 1 to 30 hours following death
Catecholaminergic pathway
Number of neurons expressing the tyrosine hydroxylase, expression of alpha and beta adrenergic receptors, expression of dopamine-bêta-hydroxylase
Measured: between 1 to 30 hours following death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2019
- Study completionJan 2019
Why it stopped: difficulty recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Unexpected Death in Epilepsy (SUDEP)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788318
- Sponsor's protocol ID
- D50830
- Acronym
- SUDEP
- Status last verified
- Apr 2019
- First submitted
- 27 May 2016
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)
- ClinicalTrials.gov ID
- NCT02788318
- Acronym / sponsor ID
- SUDEP / D50830
- Keywords
- Epilepsy, SUDEP, Serotonin
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficulty recruiting patients
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 2 Jun 2016 (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.
The mortality rate is increased in patients with epilepsy, and especially among patients with drug-resistant epilepsy. This increased mortality is mainly related to the risk of SUDEP whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant epilepsy. The term SUDEP refers to a sudden death occurring in a patient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause. Experimental and clinical data strongly suggest that most of SUDEP result from a postictal respiratory dysfunction progressing to terminal apnea. Due to the major role of serotonin in regulating breathing rhythms and data in animal models of epilepsy, it is envisaged that an alteration of serotonergic systems of the brainstem and limbic regions may play a central role in the occurrence of SUDEP. The objective of this work is to look for abnormalities of the serotonergic transmission within regulatory regions of respiratory and autonomic functions in brain samples prospectively collected in patients died from SUDEP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| diagnostic of SUDEP | – | Other: Brain samples, Other: Skin samplespatient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause (diagnosis of SUDEP). Brain samples and skin samples are collected. |
| Control 1 | – | Other: Brain samples, Other: Skin samplesSubjects with a known epilepsy, whose death is linked to a specific cause. Brain samples and skin samples are collected. |
| Control 2 | – | Other: Brain samples, Other: Skin samplesSubjects without known pathological history, remained victims of unexplained sudden unexpected death (SUDEP) after all investigations and for which a heart rhythm disorder is suspected in first intention. Brain samples and skin samples are collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with epilepsy who died
Key inclusion criteria (2 listed)
- Age >18 years
- Postmortem time before autopsy <30 hours
Key exclusion criteria (4 listed)
- Age <18 years
- postmortem time before autopsy > 30 hours
- Any subject whose brain would be of forensic interest
- Any patient who expressed an opposition to organ donation.
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 |
|---|---|---|
| Brain samplesCollected in patients died | Other | Control 1, Control 2, diagnostic of SUDEP |
| Skin samplesCollected in patients died | Other | Control 1, Control 2, diagnostic of SUDEP |
Primary outcome
Density of Medullary 5-HT Neurons
Time frame: between 1 to 30 hours following death
5-HT1A receptor binding density in within the medulla
3 secondary outcomes
Other markers of 5HT within the medulla
Time frame: between 1 to 30 hours following death
Serotoninergic pathway in the pons, the hippocampus and the insula
Time frame: between 1 to 30 hours following death
Catecholaminergic pathway
Time frame: between 1 to 30 hours following death
Results and safety
The study was stopped early (reason given: difficulty recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
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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 Sudden Unexpected Death in Epilepsy (SUDEP), run by Hospices Civils de Lyon 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 4 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: stopped early, as of the sponsor's last update on 3 Apr 2019. 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?
The study was stopped early (reason given: difficulty recruiting patients). 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?
Density of Medullary 5-HT Neurons (time frame: between 1 to 30 hours following death). 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 3 Apr 2019.