Trial record 21 of 315 for:    Expanded Access Studies

Epidiolex and Drug Resistant Epilepsy in Children (CBD)

Expanded access is currently available for this treatment.
Verified April 2015 by Georgia Regents University
Sponsor:
Collaborator:
State of Georgia
Information provided by (Responsible Party):
Yong Park, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT02397863
First received: March 19, 2015
Last updated: April 23, 2015
Last verified: April 2015
  Purpose

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 Intervention
Epilepsy
Drug: Cannabidiol (Epidiolex)

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Open Label, Multi-Center Study to Investigate the Safety of Cannabinoid (GWP42003-P) in Children With Medication Resistant Epilepsy

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Study Start Date: December 2014
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02397863

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

Locations
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
Georgia Regents University
State of Georgia
Investigators
Principal Investigator: Yong D Park, MD Professor
  More Information

No publications provided

Responsible Party: Yong Park, Professor Child Neurology, Professor Pediatrics, Georgia Regents University
ClinicalTrials.gov Identifier: NCT02397863     History of Changes
Other Study ID Numbers: CBD02
Study First Received: March 19, 2015
Last Updated: April 23, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 30, 2015