- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01983722
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
July 9, 2019 updated by: Children's Hospital Medical Center, Cincinnati
Expanded access to Stiripentol for patients with Dravet Syndrome.
Study Overview
Detailed Description
This is a treatment plan, and therefore patients will be monitored according to clinical standard of care.
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 7, 2013
First Submitted That Met QC Criteria
November 7, 2013
First Posted (ESTIMATE)
November 14, 2013
Study Record Updates
Last Update Posted (ACTUAL)
July 11, 2019
Last Update Submitted That Met QC Criteria
July 9, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-5518
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dravet Syndrome
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University Health Network, TorontoZogenix, Inc.Not yet recruiting
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TakedaActive, not recruitingDravet Syndrome (DS)China, United States, Canada, France, Hungary, Australia, Poland, Spain, Japan, Belgium, Greece, Brazil, Serbia, Germany, Italy, Latvia, Netherlands, Russian Federation, Ukraine
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TakedaRecruitingLennox Gastaut Syndrome (LGS) | Dravet Syndrome (DS)United States, China, Spain, France, Belgium, Australia, Brazil, Canada, Germany, Greece, Hungary, Italy, Japan, Latvia, Netherlands, Poland, Serbia, Mexico, Russian Federation, Ukraine
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TakedaRecruitingDravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)Spain
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TakedaActive, not recruitingEpilepsy | Dravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)United States, Canada, Australia, China, Israel, Poland, Spain, Portugal
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Encoded TherapeuticsRecruiting
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Boston Children's HospitalEncoded TherapeuticsRecruitingDravet SyndromeUnited States
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Stoke Therapeutics, IncCompleted
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Fondazione Policlinico Universitario Agostino Gemelli...IRCCS San RaffaeleEnrolling by invitation
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Zogenix International Limited, Inc., a subsidiary...CompletedDravet SyndromeUnited States, United Kingdom, Spain, Belgium, Italy, Australia, Denmark, Germany, Canada, Japan, Netherlands, France
Clinical Trials on Stiripentol
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BiocodexCompletedPrimary HyperoxaluriaFrance
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BiocodexRecruitingChronic Renal InsufficiencyBulgaria
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Cook Children's Health Care SystemNo longer availableDravet Syndrome | Epileptic Encephalopathies Associated With SCN1A MutationsUnited States
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BiocodexCompleted
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University of Colorado, DenverNo longer available
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BiocodexRecruitingPharmacoresistant Focal EpilepsiesFrance
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Assistance Publique - Hôpitaux de ParisRecruiting
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University College, LondonThe Leeds Teaching Hospitals NHS Trust; Cambridge University Hospitals NHS... and other collaboratorsUnknown