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Neuronal Excitability of HCN1 Channel Mutations in Dravet Syndrome (EXCIDRAH)

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ClinicalTrials.gov Identifier: NCT02896608
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:
This study addresses the changes in the axonal excitability parameters. It will compare these changes in patients with early infantile epileptic encephalopathy with HCN1 channel mutation and in control patients, with and without epilepsy.

Condition or disease Intervention/treatment
Dravet Syndrome Device: measure of neuronal excitability

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Neuronal Excitability of Hyperpolarization-activated Cyclic Nucleotide-gated (HCN1) Channel Mutations in Dravet Syndrome
Actual Study Start Date : October 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020


Group/Cohort Intervention/treatment
Dravet syndrome - HCN1 channel mutation
early infantile epileptic encephalopathy with HCN1 channel mutation
Device: measure of neuronal excitability
control with epilepsy Device: measure of neuronal excitability
control without epilepsy Device: measure of neuronal excitability



Primary Outcome Measures :
  1. hyperpolarizing electrotonus [ Time Frame: baseline ]
  2. hyperpolarizing threshold current [ Time Frame: baseline ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with Dravet syndrome and control patients with and without epilepsy.
Criteria

Inclusion Criteria:

  • early infantile epileptic encephalopathy with HCN1 channel mutation
  • control patients with no neurologic pathology (age, gender and body temperature matched)
  • epileptic patients (age, gender and body temperature matched)

Exclusion Criteria:

  • pregnant or breast feeding patient

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): NCT02896608


Contacts
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Contact: Laurence Salomon, MD +33 1 48 03 64 31 lsalomon@fo-rothschild.fr

Locations
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France
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Laurence Salomon, MD    +33 1 48 03 64 31    lsalomon@fo-rothschild.fr   
Principal Investigator: Antoine Gueguen, MD         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02896608     History of Changes
Other Study ID Numbers: AGN_2015_11
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Epilepsies, Myoclonic
Spasms, Infantile
Syndrome
Disease
Pathologic Processes
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epileptic Syndromes