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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01983722 |
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Date of registration:
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07/11/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
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Scientific title:
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Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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Recruitment status: |
Approved for marketing |
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URL:
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https://clinicaltrials.gov/show/NCT01983722 |
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Study type:
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Expanded Access |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 6 months and older
- Diagnosis of Dravet Syndrome with 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:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dravet Syndrome
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Intervention(s)
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Drug: Stiripentol
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Secondary ID(s)
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2013-5518
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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