Dravet SyndromeEXCIDRAHNCT02896608
Neuronal Excitability of HCN1 Channel Mutations in Dravet Syndrome
An observational study of Dravet Syndrome, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dravet Syndrome
- What is being tested?
- measure of neuronal excitability
- Type of treatment
- Medical device
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 29 Oct 2015to 16 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with Dravet syndrome and control patients with and without epilepsy.
Who may be able to join
- 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)
Who cannot join
- pregnant or breast feeding patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuronal Excitability of Hyperpolarization-activated Cyclic Nucleotide-gated (HCN1) Channel Mutations in Dravet Syndrome
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.
- Conditions
- Dravet Syndrome
- Being tested
- measure of neuronal excitability
- Medical subject headings
- Epilepsies, Myoclonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure of neuronal excitabilityDevice
| Study group | Role | What they receive |
|---|---|---|
| Dravet syndrome - HCN1 channel mutation | early infantile epileptic encephalopathy with HCN1 channel mutation Receives: Device: measure of neuronal excitability | |
| control with epilepsy | Not described Receives: Device: measure of neuronal excitability | |
| control without epilepsy | Not described Receives: Device: measure of neuronal excitability |
What is being measured
The primary outcome is the main question the study is designed to answer.
hyperpolarizing electrotonus
Measured: baseline
hyperpolarizing threshold current
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start29 Oct 2015
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dravet SyndromeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896608
- Sponsor's protocol ID
- AGN_2015_11
- Acronym
- EXCIDRAH
- Status last verified
- Feb 2023
- First submitted
- 23 Aug 2016
- Last updated
- 15 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal Excitability of Hyperpolarization-activated Cyclic Nucleotide-gated (HCN1) Channel Mutations in Dravet Syndrome
- ClinicalTrials.gov ID
- NCT02896608
- Acronym / sponsor ID
- EXCIDRAH / AGN_2015_11
- Conditions
- Dravet Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 29 Oct 2015 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dravet syndrome - HCN1 channel mutation | – | Device: measure of neuronal excitabilityearly infantile epileptic encephalopathy with HCN1 channel mutation |
| control with epilepsy | – | Device: measure of neuronal excitability |
| control without epilepsy | – | Device: measure of neuronal excitability |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with Dravet syndrome and control patients with and without epilepsy.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- pregnant or breast feeding patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measure of neuronal excitability | Device | Dravet syndrome - HCN1 channel mutation, control with epilepsy, control without epilepsy |
Primary outcome
hyperpolarizing electrotonus
Time frame: baseline
hyperpolarizing threshold current
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dravet Syndrome, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hyperpolarizing electrotonus (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.