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Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)

Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02788318
Acronym
SUDEP
Enrollment
2
Registered
2016-06-02
Start date
2014-01-31
Completion date
2019-01-31
Last updated
2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden Unexpected Death in Epilepsy (SUDEP)

Keywords

Epilepsy, SUDEP, Serotonin

Brief 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. 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.

Interventions

OTHERBrain samples

Collected in patients died

Collected in patients died

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>18 years * Postmortem time before autopsy \<30 hours

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Density of Medullary 5-HT Neuronsbetween 1 to 30 hours following death5-HT1A receptor binding density in within the medulla

Secondary

MeasureTime frameDescription
Catecholaminergic pathwaybetween 1 to 30 hours following deathNumber of neurons expressing the tyrosine hydroxylase, expression of alpha and beta adrenergic receptors, expression of dopamine-bêta-hydroxylase
Other markers of 5HT within the medullabetween 1 to 30 hours following deathExpression of 5HT-1A and 5HT-2 receptors, expression of 5HT transporter, Tryptophan Hydroxylase 2 (TPH2)
Serotoninergic pathway in the pons, the hippocampus and the insulabetween 1 to 30 hours following death5-HT1A receptor binding density, Expression of 5HT-1A and 5HT-2 receptors, expression of 5HT transporter, Tryptophan Hydroxylase 2 (TPH2)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026