- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01533506
Stiripentol in Dravet Syndrome
February 26, 2013 updated by: Elaine C. Wirrell, Mayo Clinic
Compassionate Use of Stiripentol in Intractable Epilepsy Due to Dravet Syndrome
The patient has failed all other available agents and has intractable epilepsy due to Dravet Syndrome.
Stiripentol is highly efficacious in Dravet Syndrome.
The overall goals of therapy with Stiripentol are primarily to significantly reduce the frequency and severity of seizures.
Study Overview
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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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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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
11 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures
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.
Sponsor
Investigators
- Principal Investigator: Elaine Wirrell, MD, Mayo Clinic
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 Major Dates
Study Start
February 1, 2012
Primary Completion (Anticipated)
February 1, 2013
Study Completion (Anticipated)
February 1, 2013
Study Registration Dates
First Submitted
February 9, 2012
First Submitted That Met QC Criteria
February 14, 2012
First Posted (Estimate)
February 15, 2012
Study Record Updates
Last Update Posted (Estimate)
February 28, 2013
Last Update Submitted That Met QC Criteria
February 26, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-000690
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.Terminated
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TakedaCompletedDravet Syndrome (DS)China, Canada, France, Hungary, Poland, United States, Spain, Greece, Australia, Brazil, Serbia, Germany, Italy, Japan, Latvia, Netherlands, Ukraine, Russian Federation
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University of Colorado, DenverUCB PharmaRecruitingDravet Syndrome (DS) | Children Under 2 YearsUnited States
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Alexander RotenbergA-SynapticNot yet recruitingDravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)United States
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TakedaCompletedDravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)Spain
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TakedaWithdrawnDravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)
-
TakedaTerminatedDravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)Denmark
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TakedaTerminatedLennox Gastaut Syndrome (LGS) | Dravet Syndrome (DS)United States, China, Canada, France, Australia, Poland, Belgium, Spain, Hungary, Serbia, Greece, Japan, Latvia, Netherlands, Ukraine, Brazil, Mexico, Italy, Russia, Germany
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TakedaTerminatedEpilepsy | Dravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)United States, Canada, Australia, Israel, Poland, Spain, China, Portugal
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Fondazione Policlinico Universitario Agostino Gemelli...Completed
Clinical Trials on stiripentol
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BiocodexCompletedEpilepsy | Dravet Syndrome | Pediatric Epilepsy | Epileptic Encephalopathy | ChildhoodFrance
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BiocodexCompletedPrimary HyperoxaluriaFrance
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Children's Hospital Medical Center, CincinnatiApproved for marketingDravet SyndromeUnited States
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BiocodexCompletedChronic Renal InsufficiencyBulgaria
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University Hospital MarburgCompletedStatus Epilepticus
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Cook Children's Health Care SystemNo longer availableDravet Syndrome | Epileptic Encephalopathies Associated With SCN1A MutationsUnited States
-
BiocodexCompleted
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University of Colorado, DenverNo longer available
-
BiocodexExystatNot yet recruitingPrimary Hyperoxaluria Type 3 | Primary Hyperoxaluria Type 2 | Primary Hyperoxaluria Type 1
-
BiocodexCompletedPharmacoresistant Focal EpilepsiesFrance