Dravet Syndrome Clinical Trial
Official title:
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
| NCT number | NCT01983722 |
| Other study ID # | 2013-5518 |
| Secondary ID | |
| Status | Approved for marketing |
| Phase | |
| First received | |
| Last updated |
| Verified date | July 2019 |
| Source | Children's Hospital Medical Center, Cincinnati |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
Expanded access to Stiripentol for patients with Dravet Syndrome.
| Status | Approved for marketing |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 6 Months and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospital Medical Center, Cincinnati |
United States,
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