An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes

Phase 1

• Conditions: Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS); MedDRA version: 18.0 Level: PT Classification code 10073677 Term: Severe myoclonic epilepsy of infancy System Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-001834-27-ES
• Lead Sponsor: GW Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-14
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 430

Inclusion Criteria

? Patient has completed all scheduled visits in the treatment phase of their Core Study.
? Patient and/or parent(s)/legal representative must be willing and able to give informed consent/assent for participation in the study.
? Patient and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements.
? Patient and/or parent(s)/legal representative is willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 430
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Patient is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex®) within the three months prior to study entry, not including IMP received during the Core study.
? Patient is unwilling to abstain from using recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex) during the study.
? Patient has a history of symptoms (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope) related to a drop in blood pressure due to postural changes.
? Any history of suicidal behavior or any suicidal ideation of type four or five on the C-SSRS at Visit 1.
? Patient has been part of a clinical trial involving an IMP during the inter-study period.
? Patient has previously been enrolled and dosed in this study.
? Female patient is of child bearing potential and must have a negative pregnancy test and be willing and able to use a reliable method of contraception throughout the trial and for three months after last dose. Male patient?s partner is of child bearing potential; unless willing to ensure that they or their partner use a highly effective contraception. In the context of this trial, a highly effective method is defined as those which result in low failure rate (i.e., less than 1% per year) when used consistently and correctly such as: combined or progesterone only oral contraceptives, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
? Female patient is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
? Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient?s ability to participate in the study.
? Following a physical examination the patient has any abnormalities that, in the opinion of the investigator, would prevent the patient from safe participation in the study.
? Patient is unwilling to abstain from donation of blood during the study.
? Patient has significantly impaired hepatic function at the ?End of Treatment? visit of their Core Study or at Visit 1 if re-assessed (alanine aminotransferase [ALT] >5 × upper limit of normal [ULN] and total bilirubin [TBL] >2 × ULN) OR ALT or aspartate aminotransferase (AST) >3 × ULN and TBL >2 × ULN or international normalized ratio [INR] >1.5).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified