NCT02896608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2019

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

4 years

First QC Date

August 23, 2016

Last Update Submit

February 14, 2023

Conditions

Dravet Syndrome

Outcome Measures

Primary Outcomes (2)

  • hyperpolarizing electrotonus

    baseline

  • hyperpolarizing threshold current

    baseline

Study Arms (3)

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

measure of neuronal excitabilityDEVICE
Dravet syndrome - HCN1 channel mutationcontrol with epilepsycontrol without epilepsy

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • pregnant or breast feeding patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Epilepsies, Myoclonic

Condition Hierarchy (Ancestors)

Epilepsy, GeneralizedEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

September 12, 2016

Study Start

October 29, 2015

Primary Completion

October 16, 2019

Study Completion

October 16, 2019

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

FR(1)