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Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY (MIRESPILEPSY)

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ClinicalTrials.gov Identifier: NCT03419000
Recruitment Status : Not yet recruiting
First Posted : February 1, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Sudden and unexpected death in epilepsy (SUDEP) has become a major issue for patients with epilepsy and their physicians. SUDEP is a nontraumatic and non-drowning death in patients with epilepsy, unrelated to a documented status epilepticus, in which postmortem examination does not reveal a toxicologic or anatomic cause of death. It primarily affects young adults with drug-resistant epilepsy, with an incidence of about 0.5%/year. A recent study reported that up to 20% of patients with childhood onset drug resistant epilepsy will die of a SUDEP by the age of 45. Apart from optimizing antiepileptic drugs, no preventive treatment is available to prevent SUDEP. As underscored by the World Health Organization (WHO), there is an urgent need to develop specific therapeutic approaches to tackle this issue.

The primary objective of the proposal is to evaluate the diagnostic value of a set of circulating microRNAs pre-selected because of their implication in the regulation of molecular pathways involved in the respiratory regulation to identify patients with seizure-related respiratory dysfunction, as defined by occurrence ictal/peri-ictal pulse oxymetry < 90%.

A total of 50 patients will be included over a period of one year. Patients undergoing long-term video-EEG/SEEG monitoring will be recruited in the epilepsy monitoring unit of the Department of Functional Neurology and Epileptology, Hospices Civils de Lyon, Lyon, France.

It will be a case-control study in a cohort of patients with drug-resistant focal epilepsy undergoing long-term video-EEG monitoring, in which patients who demonstrate ictal/post-ictal hypoxemia (cases) will be compared with those without seizure-related respiratory dysfunction (controls).


Condition or disease Intervention/treatment Phase
Drug Resistant Epilepsy Genetic: blood sample Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 2, 2019
Estimated Study Completion Date : October 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient
Patients suffering from drug-resistant focal epilepsy or from drug-resistant generalized epilepsy according to ILAE classification and undergoing long-term video-EEG monitoring in Epilepsy unit of Lyon to record and characterize her/his seizure
Genetic: blood sample
Seven blood samples (4 ml each on 5 EDTA and 2 dry tubes) will be collected in each patient/ healthy volunteers subject to determine the expression profile of miRNAs in the plasma as well as in the exosomes

Active Comparator: healthy volunteers
Adult (≥ 18 years) Without history of neurological disorders and/or psychiatric disorders, and/or general medical disorders
Genetic: blood sample
Seven blood samples (4 ml each on 5 EDTA and 2 dry tubes) will be collected in each patient/ healthy volunteers subject to determine the expression profile of miRNAs in the plasma as well as in the exosomes




Primary Outcome Measures :
  1. Relation between the expression level of circulating microRNAs and the occurrence of SpO2 <90% during at least 5 seconds within the course of the seizure and/or within the five minutes following the end of the seizure [ Time Frame: Day 0 ]
    The primary objective of the proposal is to evaluate the diagnostic value of a set of circulating microRNAs pre-selected because of their implication in the regulation of molecular pathways involved in the respiratory regulation to identify patients with seizure-related respiratory dysfunction, as defined by occurrence ictal/peri-ictal pulse oxymetry < 90%


Secondary Outcome Measures :
  1. Relation between the expression level of circulating microRNAs and the desaturation nadir [ Time Frame: Day 0 ]
    Evaluating the relation between a set of circulating microRNAs and the severity of the seizure-related respiratory dysfunction, as defined by the desaturation nadir

  2. Relation between the expression level of circulating microRNAs and the patient's age [ Time Frame: Day 0 ]
  3. Relation between the expression level of circulating microRNAs and the epilepsy duration [ Time Frame: Day 0 ]
  4. Relation between the expression level of circulating microRNAs and the total number of seizures (ie focal seizures and GTCS) over the past three months [ Time Frame: Day 0 ]
  5. Relation between the expression level of circulating microRNAs and the Number of GTCS over the past three months [ Time Frame: Day 0 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For the patients :

  • Adult patient (≥ 18 years) suffering from drug-resistant focal epilepsy or from drug-resistant generalized epilepsy according to ILAE classification
  • Patient undergoing long-term video-EEG monitoring in Epilepsy unit of Lyon to record and characterize her/his seizure
  • Patient who gave her/his written informed consent to participate to the study
  • Patient affiliated to the French health care system

For the healthy volunteers :

  • Adult (≥ 18 years)
  • Without history of neurological disorders and/or psychiatric disorders, and/or general medical disorders
  • Subject who gave her/his written informed consent to participate to the study
  • Subject affiliated to the French health care system

Exclusion Criteria:

For the patients :

  • Ongoing major depressive episode as defined by a score ≥ 15 at the French version of the NDDI-E scale*
  • Current panic disorder as defined by a score ≥ 7 at the French version of the GAD-7 scale*
  • Ongoing treatment with selective serotonin reuptake inhibitor
  • Patient who benefit from a protective measure

For the healthy volunteers :

  • Presence of the symptoms of anxiety and/or depression as defined by a score ≥ 11 at the French version of the Hospital Anxiety and Depression Scale (HADS)
  • Ongoing treatment with selective serotonin reuptake inhibitor
  • Subjects with these psychiatric comorbidities and/or treatment will be excluded in order to limit risk that the relation previously reported between miR-135a, miR-16, miR-1202 and depression and/or panic disorder and/or response to selective serotonin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419000


Contacts
Contact: Sylvain RHEIMS 472357106 ext +33 sylvain.rheims@chu-lyon.fr
Contact: Anne-Laure CHARLOIS 472355837 ext +33 anne-laure.charlois@chu-lyon.fr

Locations
France
Hospices Civils de Lyon Not yet recruiting
Bron, France, 69500
Contact: Sylvain RHEIMS    472357106 ext +33    sylvain.rheims@chu-lyon.fr   
Contact: Anne-Laure CHARLOIS    472355837 ext +33    anne-laure.charlois@chu-lyon.fr   
Principal Investigator: Sylvain RHEIMS         
Sub-Investigator: Laurent BEZIN         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sylvain RHEIMS Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03419000     History of Changes
Other Study ID Numbers: 69HCL17_0666
2017-A03307-46 ( Other Identifier: ID-RCB )
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
GTCS
Epilepsies, Partial
Drug Resistant Epilepsy
Circulating MicroRNA
Diagnostic

Additional relevant MeSH terms:
Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases