Neuronal Excitability of HCN1 Channel Mutations in Dravet... | NCT02896608

Studies
Neuronal Excitability of HCN1 Channel Mutations in Dravet Syndrome

NCT02896608

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Feb 15, 2023Actual

Enrollment

92Actual

Phase

Not provided

Conditions

Dravet Syndrome

Interventions

measure of neuronal excitability

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2015Actual

Primary Completion Date

Oct 16, 2019Actual

Completion Date

Oct 16, 2019Actual

First Submitted Date

Aug 23, 2016

First Submission Date that Met QC Criteria

Sep 6, 2016

First Posted Date

Sep 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2023

Last Update Posted Date

Feb 15, 2023Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
measure of neuronal excitability	Device		Dravet syndrome - HCN1 channel mutation control with epilepsy control without epilepsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hyperpolarizing electrotonus		baseline
hyperpolarizing threshold current		baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with Dravet syndrome and control patients with and without epilepsy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Ophtalmologique Adolphe de Rothschild		Paris		75019	France

Condition Browse Module

MeSH Terms

ID	Term
D004831	Epilepsies, Myoclonic

Ancestor Terms

ID	Term
D004829	Epilepsy, Generalized
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided