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

Sudden Unexpected Death in Epilepsy (SUDEP) Clinical Trial

— SUDEP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02788318
• Other study ID #: D50830
• Status: Terminated
• Start date: January 2014
• Est. completion date: January 2019

Study information

• Verified date: April 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Epilepsy
• Sudden Unexpected Death in Epilepsy (SUDEP)

Intervention

Other:
• Brain samples
Collected in patients died
• Skin samples
Collected in patients died

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Institut Médico-Légal	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Density of Medullary 5-HT Neurons	5-HT1A receptor binding density in within the medulla	between 1 to 30 hours following death
Secondary	Other markers of 5HT within the medulla	Expression of 5HT-1A and 5HT-2 receptors, expression of 5HT transporter, Tryptophan Hydroxylase 2 (TPH2)	between 1 to 30 hours following death
Secondary	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)	between 1 to 30 hours following death
Secondary	Catecholaminergic pathway	Number of neurons expressing the tyrosine hydroxylase, expression of alpha and beta adrenergic receptors, expression of dopamine-bêta-hydroxylase	between 1 to 30 hours following death