Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome

NCT ID: NCT01983722

Last Updated: 2019-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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Expanded access to Stiripentol for patients with Dravet Syndrome.

Detailed Description

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This is a treatment plan, and therefore patients will be monitored according to clinical standard of care.

Conditions

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Dravet Syndrome

Interventions

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Stiripentol

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2013-5518

Identifier Type: -

Identifier Source: org_study_id

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