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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02224690
Date of registration: 21/08/2014
Prospective Registration: Yes
Primary sponsor: GW Research Ltd
Public title: A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults GWPCARE4
Scientific title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults.
Date of first enrolment: April 28, 2015
Target sample size: 171
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02224690
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Netherlands Poland United States
Contacts
Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Participant must have been male or female aged between 2 and 55 years (inclusive).

- Participant must have had a documented history of Lennox-Gastaut syndrome. This
included written documentation of having met electroencephalogram (EEG) diagnostic
criteria during the participant's history and evidence of at least 1 type of
generalized seizure, including drop seizures (atonic, tonic, tonic-clonic or
myoclonic) for at least 6 months.

- Participants had a history of slow (<3.0 Hertz) spike-and-wave pattern in an EEG prior
to the enrollment into the baseline period.

- Participants were refractory; that is having documented failures on more than one
antiepileptic drug (AED).

- Participant must have been taking 1 or more AEDs at a dose which has been stable for
at least 4 weeks prior to screening.

- All medications or interventions for epilepsy (including ketogenic diet and vagus
nerve stimulation [VNS]) must have been stable for 4 weeks prior to screening and
participant is willing to maintain a stable regimen throughout the study. The
ketogenic diet and VNS treatments are not accounted as an AED.

Key Exclusion Criteria:

- Etiology of participant's seizures was a progressive neurologic disease. Participants
with tuberous sclerosis were not excluded from study participation, unless there was a
progressive tumor.

- Participant had an anoxic episode requiring resuscitation within 6 months of
screening.

- Participant had clinically significant unstable medical conditions other than
epilepsy.

- Participant had clinically relevant symptoms or a clinically significant illness in
the 4 weeks prior to screening or randomization, other than epilepsy.

- Participant was currently using or has in the past used recreational or medicinal
cannabis, or synthetic cannabinoid based medications (including Sativex®) within the 3
months prior to study entry and was unwilling to abstain for the duration of the
study.

- Participant had any known or suspected hypersensitivity to cannabinoids or any of the
excipients of the Investigational Medicinal Product (IMP), such as sesame oil.

- Participant had been part of a clinical trial involving another IMP in the previous 6
months.

- Participant had significantly impaired hepatic function at screening or randomization
(Alanine aminotransferase [ALT] >5 x upper limit of normal [ULN] or total bilirubin
[TBL] >2 x ULN) OR the ALT or Aspartate aminotransferase (AST) >3 x ULN and (TBL >2 x
ULN or international normalized ratio >1.5). This criterion can only be confirmed once
the laboratory results are available; Participants randomized into the study who are
later found not to meet this criterion should be withdrawn from the study.

- Any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the
Columbia Suicide Severity Rating Scale in the last month or at screening.

- Participant was taking more than 4 concurrent AEDs.

- Participant was taking corticotropins in the 6 months prior to screening.

- Participant was taking long-term systemic steroids (excluding inhaled medication for
asthma treatment) or any other daily medication known to exacerbate epilepsy. An
exception was made of prophylactic medication, for example, idiopathic nephrotic
syndrome or asthma.

- Participant was taking felbamate, and they had been taking it for less than 1 year
prior to screening.



Age minimum: 2 Years
Age maximum: 55 Years
Gender: All
Health Condition(s) or Problem(s) studied
Epilepsy
Lennox-Gastaut Syndrome
Intervention(s)
Drug: GWP42003-P 20 mg/kg/day Dose
Drug: Placebo
Primary Outcome(s)
Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period [Time Frame: Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)]
Secondary Outcome(s)
Number Of Participants With a =50% Reduction From Baseline in Drop Seizure Frequency During The Treatment Period [Time Frame: Baseline to EOT (Day 99) or ET]
Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period [Time Frame: Baseline to EOT (Day 99) or ET]
Subject/Caregiver Global Impression Of Change Assessment (S/CGIC) [Time Frame: Baseline to Last Visit (Day 99) or ET]
Secondary ID(s)
2014-002941-23
GWEP1423
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 27/07/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02224690
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