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Trial record 26 of 191 for:    epidiolex

Epidiolex and Drug Resistant Epilepsy in Children (CBD)

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ClinicalTrials.gov Identifier: NCT02397863
Expanded Access Status : Available
First Posted : March 25, 2015
Last Update Posted : April 24, 2015
Sponsor:
Collaborator:
State of Georgia
Information provided by (Responsible Party):
Yong Park, Augusta University

Brief Summary:
This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy.

Condition or disease Intervention/treatment
Epilepsy Drug: Cannabidiol (Epidiolex)

Detailed Description:
This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy. The study consists of an 8 week baseline, titration, and treatment of Epidiolex in a daily dosage up to 25 mg/kg/day, with an optional secondary titration schedule after 26 weeks of treatment up to a maximal daily dosage up to 50 m/kg/day until End of Treatment, followed by a taper-down period, and a safety follow up. Treatment will be provided for a total of 52 weeks with an interim analysis conducted 12 weeks after achieving maximal dose (either 25 mg/kg/day or optimal dose with regards to safety and tolerability) and at the end of 1 year of treatment with treatment extensions conducted beyond 52 weeks until such time as there is market authorization for Epidiolex, if Epidiolex becomes unavailable, or the study is terminated. Cessation of Epidiolex administration will be concluded with a taper period and follow-up visit 4 weeks after the taper.

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Study Type : Expanded Access
Official Title: An Open Label, Multi-Center Study to Investigate the Safety of Cannabinoid (GWP42003-P) in Children With Medication Resistant Epilepsy
Study Start Date : December 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy


Intervention Details:
  • Drug: Cannabidiol (Epidiolex)
    Daily dosage up to 25 mg/kg/day with an optional up titration to a maximal daily dosage up to 50 m/kg/day until End of Treatment.
    Other Name: Epidiolex

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient should have history of trying at least four antiepileptic drugs (AEDs), including one trial of a combination of two concomitant drugs, without successful seizure control. Vagal nerve stimulation, RNS deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial.
  • Patient must be taking two or more AEDs at a dose which has been stable for at least four weeks.
  • A State of Georgia resident.

Exclusion Criteria:

  • Patient is diagnosed as having Dravet Syndrome or Lennox-Gastaut Syndrome and eligible for a GW Pharmaceutical-Sponsored Clinical Trial.
  • Patients who have been part of a clinical trial involving another investigational product in the previous six months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397863


Contacts
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Contact: Yong D Park, MD 706-721-3371 ypark@gru.edu
Contact: GRU Clinical Trials Office 706-721-9680 ctscto@gru.edu

Locations
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United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
Contact: Yong D Park, MD    706-721-3371    ypark@gru.edu   
Contact: GRU Clinical Trials Office    706-721-9680    ctscto@gru.edu   
Sponsors and Collaborators
Augusta University
State of Georgia
Investigators
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Principal Investigator: Yong D Park, MD Professor

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Responsible Party: Yong Park, Professor Child Neurology, Professor Pediatrics, Augusta University
ClinicalTrials.gov Identifier: NCT02397863     History of Changes
Other Study ID Numbers: CBD02
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epidiolex
Anticonvulsants