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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:  NCT02224560
Date of registration: 21/08/2014
Prospective Registration: Yes
Primary sponsor: GW Research Ltd
Public title: Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults GWPCARE3
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: June 8, 2015
Target sample size: 225
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02224560
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
France Spain United Kingdom United States
Contacts
Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Participant and/or parent(s)/legal representatives were willing and able to give
informed assent/consent for participation in the study.

- Participant and his or her caregivers were willing and able (in the investigator's
opinion) to comply with all study requirements.

- Participant was male or female aged between 2 and 55 years (inclusive).

- Participant had a documented history of LGS. 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.

- Participant had a history of slow (<3.0 hertz [Hz]) spike-and-wave pattern in an EEG
prior to the enrollment into the baseline period.

- Participant had at least 2 drop seizures each week during the first 28 days of the
baseline period.

- Participant was refractory; that is having documented failures on more than 1
antiepileptic drug (AED).

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

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

- Participant and/or parent(s)/legal representatives were willing to allow his or her
primary care practitioner and consultant to be notified of participation in the study.

- Participant completed his or her interactive voice response (IVRS) telephone diary on
at least 25 days of the baseline period.

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 had a history or presence of alcohol or substance abuse within the last 2
years prior to the study or daily consumption of 5 or more alcohol-containing
beverages.

- Participant was currently using or had 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 a history of symptoms (for example, dizziness, light-headedness,
blurred vision, palpitations, weakness, syncope) related to a drop in blood pressure
due to postural changes.

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

- Female participant was of child bearing potential or male participant's partner was of
child bearing potential; unless willing to ensure that they or their partner used a
highly effective method of contraception for the duration of the study and for 3
months thereafter.

- Female participant was pregnant (positive pregnancy test), lactating or planning
pregnancy during the course of the study and for 3 months thereafter.

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

- Patient had significantly impaired hepatic function at screening (Day -28) or
randomization (Day 1), defined as any of the following: alanine aminotransferase (ALT)
or aspartate aminotransferase (AST) > 5 × upper limit of normal (ULN); ALT or AST > 3
× ULN and total bilirubin > 2 × ULN or international normalized ratio (INR) > 1.5; ALT
or AST > 3 × ULN with the presence of fatigue, nausea, vomiting, right upper quadrant
pain or tenderness, fever, rash, and/or eosinophilia (>5%). This criterion could only
be confirmed once the laboratory results were available; participants randomized into
the study who were later found not to meet this criterion were 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 unwilling to abstain from donation of blood during the study.

- Participant planned to travel outside his or her country of residence during the
study.

- Participant had previously randomized into the study.

- Participant was taking more than 4 concurrent AEDs.

- Participant had taken corticotropins in the 6 months prior to screening.

- Participant was currently 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 he or she 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
Drug: Placebo control
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 (S/CGIC) Assessment [Time Frame: Baseline to Last Visit (Day 99) or ET]
Secondary ID(s)
2014-002940-42
GWEP1414
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/NCT02224560
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