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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR STIRIPENTOL

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Clinical Trials for Stiripentol

Trial ID Title Status Sponsor Phase Summary
NCT01533506 Stiripentol in Dravet Syndrome No longer available Mayo Clinic Phase 4 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.
NCT01835314 Compassionate Use of Stiripentol in Dravet Syndrome Available University of Colorado, Denver N/A Compassionate use of Stiripentol in Dravet Syndrome. This is a treatment protocol, not a research study, therefore children will only be monitored on a clinical basis for seizure improvement predominantly by parent and caregiver report.
NCT01983722 Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome Available Children's Hospital Medical Center, Cincinnati N/A Expanded access to Stiripentol for patients with Dravet Syndrome.
NCT02205931 Ketogenic Diet in Infants With Epilepsy (KIWE) Recruiting Alder Hey Children's NHS Foundation Trust Phase 4 Epilepsy, a condition where individuals are prone to recurrent epileptic seizures, is the most common chronic neurological disorder in children. Epilepsy onset is most common in the first two years of life and is associated with poor prognosis for seizure control and neurodevelopmental outcome. The ketogenic diet (KD) is a medically supervised diet that is high in fat and restricted in carbohydrates and protein. KD therapy has shown to be an effective treatment for seizures in children with epilepsy older than two. Associated benefits include: a reduced requirement for routine and emergency antiepileptic drugs (AED) and fewer seizure related hospital admissions. Although reports suggest that KD therapy improves seizures in younger children there is no high quality trial data that demonstrates effectiveness and safety in this age group. The KD is resource intensive, requiring dietetic and physician time; data is required to justify expansion of services to cater for the apparent need. The investigators therefore propose a prospective multicentre randomised trial to investigate the effectiveness and safety of the KD in children with epilepsy under the age of 2, who have failed to respond to two or more AEDs. Children will be randomly assigned to either receive the KD or further AEDs. The allocated treatment will be started after a 2week baseline period, and it's effectiveness assessed after 8 weeks. Seizure diaries will be used to record seizures and related events, a questionnaire will be used to assess diet tolerance; also growth and blood biochemistry will be monitored. The information obtained from this study is necessary to optimise choices in epilepsy treatment, aiming to improve outcomes and thus determine whether and when the KD should should be used.
NCT02205931 Ketogenic Diet in Infants With Epilepsy (KIWE) Recruiting Birmingham Children's Hospital NHS Foundation Trust Phase 4 Epilepsy, a condition where individuals are prone to recurrent epileptic seizures, is the most common chronic neurological disorder in children. Epilepsy onset is most common in the first two years of life and is associated with poor prognosis for seizure control and neurodevelopmental outcome. The ketogenic diet (KD) is a medically supervised diet that is high in fat and restricted in carbohydrates and protein. KD therapy has shown to be an effective treatment for seizures in children with epilepsy older than two. Associated benefits include: a reduced requirement for routine and emergency antiepileptic drugs (AED) and fewer seizure related hospital admissions. Although reports suggest that KD therapy improves seizures in younger children there is no high quality trial data that demonstrates effectiveness and safety in this age group. The KD is resource intensive, requiring dietetic and physician time; data is required to justify expansion of services to cater for the apparent need. The investigators therefore propose a prospective multicentre randomised trial to investigate the effectiveness and safety of the KD in children with epilepsy under the age of 2, who have failed to respond to two or more AEDs. Children will be randomly assigned to either receive the KD or further AEDs. The allocated treatment will be started after a 2week baseline period, and it's effectiveness assessed after 8 weeks. Seizure diaries will be used to record seizures and related events, a questionnaire will be used to assess diet tolerance; also growth and blood biochemistry will be monitored. The information obtained from this study is necessary to optimise choices in epilepsy treatment, aiming to improve outcomes and thus determine whether and when the KD should should be used.
NCT02205931 Ketogenic Diet in Infants With Epilepsy (KIWE) Recruiting Bristol Royal Hospital for Children Phase 4 Epilepsy, a condition where individuals are prone to recurrent epileptic seizures, is the most common chronic neurological disorder in children. Epilepsy onset is most common in the first two years of life and is associated with poor prognosis for seizure control and neurodevelopmental outcome. The ketogenic diet (KD) is a medically supervised diet that is high in fat and restricted in carbohydrates and protein. KD therapy has shown to be an effective treatment for seizures in children with epilepsy older than two. Associated benefits include: a reduced requirement for routine and emergency antiepileptic drugs (AED) and fewer seizure related hospital admissions. Although reports suggest that KD therapy improves seizures in younger children there is no high quality trial data that demonstrates effectiveness and safety in this age group. The KD is resource intensive, requiring dietetic and physician time; data is required to justify expansion of services to cater for the apparent need. The investigators therefore propose a prospective multicentre randomised trial to investigate the effectiveness and safety of the KD in children with epilepsy under the age of 2, who have failed to respond to two or more AEDs. Children will be randomly assigned to either receive the KD or further AEDs. The allocated treatment will be started after a 2week baseline period, and it's effectiveness assessed after 8 weeks. Seizure diaries will be used to record seizures and related events, a questionnaire will be used to assess diet tolerance; also growth and blood biochemistry will be monitored. The information obtained from this study is necessary to optimise choices in epilepsy treatment, aiming to improve outcomes and thus determine whether and when the KD should should be used.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Stiripentol

Condition Name

Condition Name for Stiripentol
Intervention Trials
Dravet Syndrome 5
Epilepsy 3
Epileptic Encephalopathies Associated With SCN1A Mutations 1
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Condition MeSH

Condition MeSH for Stiripentol
Intervention Trials
Syndrome 5
Epilepsies, Myoclonic 5
Epilepsy 4
Brain Diseases 1
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Clinical Trial Locations for Stiripentol

Trials by Country

Trials by Country for Stiripentol
Location Trials
United States 7
France 2
United Kingdom 2
Sweden 1
Spain 1
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Trials by US State

Trials by US State for Stiripentol
Location Trials
Colorado 2
Minnesota 2
California 1
Texas 1
Ohio 1
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Clinical Trial Progress for Stiripentol

Clinical Trial Phase

Clinical Trial Phase for Stiripentol
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Stiripentol
Clinical Trial Phase Trials
Recruiting 3
Available 3
Enrolling by invitation 1
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Clinical Trial Sponsors for Stiripentol

Sponsor Name

Sponsor Name for Stiripentol
Sponsor Trials
GW Research Ltd 2
Birmingham Children's Hospital NHS Foundation Trust 1
Matthew's Friends 1
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Sponsor Type

Sponsor Type for Stiripentol
Sponsor Trials
Other 15
Industry 3
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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Argus Health
Baxter
Queensland Health
Farmers Insurance
UBS
US Army
Express Scripts
Boehringer Ingelheim

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