|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02239276 |
|
Date of registration:
|
10/09/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic Encephalopathies
|
|
Scientific title:
|
Expanded Access Use of Stiripentol in Participants With Dravet Syndrome or Epileptic Encephalopathies Associated With Sodium Channel Mutations |
|
Date of first enrolment:
|
September 2014 |
|
Target sample size:
|
|
|
Recruitment status: |
No longer available |
|
URL:
|
https://clinicaltrials.gov/show/NCT02239276 |
|
Study type:
|
Expanded Access |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Scott Perry, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cook Children's Health Care System |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 6 months and older
- Diagnosis of Dravet Syndrome or epileptic encephalopathies associated with SCN1A
mutations defined as:
- A documented gene mutation reported to result in Dravet syndrome phenotype; OR
- Clinical confirmation of Dravet syndrome by two pediatric neurologists; OR
- Clinical confirmation of other epileptic encephalopathies associated with sodium
channel mutations
- Failure of at least 2 therapeutic anticonvulsants (excluding Na Channel blockers)
indicative of intractable seizures
Exclusion Criteria:
- Hypersensitivity to the active substance or to any of the excipients
- Past history of psychoses in the form of episodes of delirium
- Impaired hepatic and/or renal function, defined as creatinine >2 and/or transaminase
>4xULN
Age minimum:
6 Months
Age maximum:
18 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Epileptic Encephalopathies Associated With SCN1A Mutations
|
|
Dravet Syndrome
|
|
Intervention(s)
|
|
Drug: Stiripentol
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|