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Trial record 77 of 191 for:    epidiolex

An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

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ClinicalTrials.gov Identifier: NCT02544750
Recruitment Status : Enrolling by invitation
First Posted : September 9, 2015
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

Brief Summary:
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.

Condition or disease Intervention/treatment Phase
Tuberous Sclerosis Complex Seizures Drug: GWP42003-P Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled Seizures
Study Start Date : August 2016
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022


Arm Intervention/treatment
Experimental: GWP42003-P
100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening). Participants will be dosed up to a maximum of 50 mg/kg/day. Dose may be lower if Investigator judges benefit and/or tolerability issues.
Drug: GWP42003-P
Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Other Names:
  • Cannabidiol
  • CBD




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: From OLE screening until market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]

Secondary Outcome Measures :
  1. Change in seizure frequency [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  2. Number of treatment responders [ Time Frame: Once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  3. Number of participants with worsening, no change, or improvements in seizure frequency [ Time Frame: Once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  4. Change in composite focal seizure score [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  5. Change in number of seizure-free days [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  6. Change in number of seizures by subtype [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  7. Change in number of infantile/epileptic spasms. [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  8. Change in use of rescue medication [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  9. Change in number of episodes of status epilepticus [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  10. Change in duration of seizures by subtype [ Time Frame: Once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  11. Change in overall condition as assessed by the participant/caregiver [ Time Frame: Once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  12. Change in overall condition as assessed by the physician [ Time Frame: Once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  13. Change in Vineland-II score [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  14. Change in Wechsler score by subtest [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  15. Change in Behavior Checklist score [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  16. Change in Social Communication Questionnaire score [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  17. Change in Quality of Life score [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  18. Change in serum IGF-1 levels [ Time Frame: Baseline and once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  19. Number of participants with changes in Tanner stage [ Time Frame: Once market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]
  20. Incidence of suicidality [ Time Frame: From OLE screening until market authorization is granted for GWP42003-P in TSC (anticipated to be 2 years after the OLE trial start date) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Completion of the GWEP1521 Blinded Phase

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): NCT02544750


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
GW Research Ltd

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Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT02544750     History of Changes
Other Study ID Numbers: GWEP1521 Open-Label Extension
2015-002154-12 ( EudraCT Number )
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Epidiolex
Sclerosis
Seizures
Tuberous Sclerosis
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hamartoma
Neoplasms
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Malformations of Cortical Development, Group I
Malformations of Cortical Development
Nervous System Malformations
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Anticonvulsants