Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02544763
Registration number
NCT02544763
Ethics application status
Date submitted
7/09/2015
Date registered
9/09/2015
Date last updated
28/09/2022
Titles & IDs
Public title
A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2015-002154-12
Query!
Secondary ID [2]
0
0
GWEP1521 Blinded Phase
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Tuberous Sclerosis Complex
0
0
Query!
Seizures
0
0
Query!
Condition category
Condition code
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Neurological
0
0
0
0
Query!
Epilepsy
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - GWP42003-P
Treatment: Drugs - Placebo
Experimental: 25 mg/kg/day GWP42003-P - 100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening).
Experimental: 50 mg/kg/day GWP42003-P - 100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening).
Placebo Comparator: Placebo - Placebo oral solution matching 100 mg/mL GWP42003-P.
Treatment: Drugs: GWP42003-P
Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Treatment: Drugs: Placebo
Yellow oily solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration)
Query!
Assessment method [1]
0
0
TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that are countable. Percent change from Baseline was calculated as the (post-Baseline value minus the Baseline value) divided by the Baseline value x 100.
Query!
Timepoint [1]
0
0
Baseline; up to Week 16
Query!
Secondary outcome [1]
0
0
Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration)
Query!
Assessment method [1]
0
0
Treatment responders are defined as those participants with a = 50% reduction in TSC-associated seizure frequency. TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that are countable. Participants who withdrew from the trial during the treatment period are considered non-responders.
Query!
Timepoint [1]
0
0
Baseline; up to Week 16
Query!
Secondary outcome [2]
0
0
Change From Baseline in the Caregiver Global Impression of Change (CGIC) or Participant Global Impression of Change (PGIC) Score at the Participant's Last Visit
Query!
Assessment method [2]
0
0
The combined caregiver and participant summary uses either the caregiver or participant version if only one version was completed, or the caregiver version if both caregiver and participant versions were completed. The CGIC comprised the following question, to be rated on a 7-point scale (1, Very Much Improved; 2, Much Improved; 3, Slightly Improved; 4, No Change; 5, Slightly Worse; 6, Much Worse; 7, Very Much Worse): "Since your child started treatment, please assess the status of your child's overall condition (comparing their condition now to their condition before treatment)." The SGIC comprised the following question, to be rated on a 7-point scale (1, Very Much Improved; 2, Much Improved; 3, Slightly Improved; 4, No Change; 5, Slightly Worse; 6, Much Worse; 7, Very Much Worse): "Since you started treatment, please assess the status of your overall condition (comparing your condition now to your condition before treatment)."
Query!
Timepoint [2]
0
0
Baseline; up to Week 16
Query!
Secondary outcome [3]
0
0
Percent Change From Baseline in Total Seizures During the Treatment Period (Maintenance and Titration)
Query!
Assessment method [3]
0
0
Total seizures included all seizure types combined. Percent change from Baseline was calculated as the (post-Baseline value minus the Baseline value) divided by the Baseline value x 100.
Query!
Timepoint [3]
0
0
Baseline; up to Week 16
Query!
Secondary outcome [4]
0
0
Number of Participants With Any Severe Treatment-emergent Adverse Event (TEAE)
Query!
Assessment method [4]
0
0
A TEAE was defined as an AE with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Query!
Timepoint [4]
0
0
up to approximately Week 22
Query!
Eligibility
Key inclusion criteria
Key
- Participant has a well-documented clinical history of epilepsy.
- Participant has a clinical diagnosis of Tuberous Sclerosis Complex (TSC) according to
the criteria agreed by the 2012 International TSC Consensus Conference.
- All medications or interventions for epilepsy (including ketogenic diet and any
neurostimulation devices for epilepsy) must have been stable for 1 month prior to
screening and the participant is willing to maintain a stable regimen throughout the
trial.
Key
Query!
Minimum age
1
Year
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Participant has a history of pseudo-seizures.
- Participant has clinically significant unstable medical conditions other than
epilepsy.
- Participant has an illness in the 4 weeks prior to screening or randomization, other
than epilepsy, which in the opinion of the investigator could affect seizure
frequency.
- Participant has undergone general anesthetic in the 4 weeks prior to screening or
randomization.
- Participant has undergone surgery for epilepsy in the 6 months prior to screening.
- Participant is being considered for epilepsy surgery or any procedure involving
general anesthesia.
- Participant has been taking felbamate for less than 1 year prior to screening.
- Participant is taking an oral mTOR inhibitor.
- Participant has any known or suspected hypersensitivity to cannabinoids or any of the
excipients of the Investigational Medicinal Product (IMP), such as sesame oil.
- Participant has any history of suicidal behavior or any suicidal ideation of type 4 or
5 on the C-SSRS in the last month or at screening.
- Participant is currently using or has in the past used recreational or medicinal
cannabis, or cannabinoid-based medications, within the 3 months prior to screening and
is unwilling to abstain for the duration for the study.
- Participant has tumor growth which, in the opinion of the Investigator, could affect
the primary endpoint.
- Participant has significantly impaired hepatic function at the screening or
randomization visit
- Participant has received an IMP within the 12 weeks prior to the screening visit.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
6/04/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
26/02/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
224
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [2]
0
0
Royal Brisbane and Women's Hospital - Herston
Query!
Recruitment hospital [3]
0
0
The Royal Melbourne Hospital - Parkville
Query!
Recruitment hospital [4]
0
0
Sydney Children's Hospital - Randwick
Query!
Recruitment postcode(s) [1]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [2]
0
0
- Herston
Query!
Recruitment postcode(s) [3]
0
0
- Parkville
Query!
Recruitment postcode(s) [4]
0
0
- Randwick
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Minnesota
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Missouri
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
North Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Oregon
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Pennsylvania
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Tennessee
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Texas
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Utah
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Virginia
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Washington
Query!
Country [20]
0
0
Netherlands
Query!
State/province [20]
0
0
Rotterdam
Query!
Country [21]
0
0
Netherlands
Query!
State/province [21]
0
0
Utrecht
Query!
Country [22]
0
0
Poland
Query!
State/province [22]
0
0
Bydgoszcz
Query!
Country [23]
0
0
Poland
Query!
State/province [23]
0
0
Kraków
Query!
Country [24]
0
0
Poland
Query!
State/province [24]
0
0
Lublin
Query!
Country [25]
0
0
Poland
Query!
State/province [25]
0
0
Warsaw
Query!
Country [26]
0
0
Poland
Query!
State/province [26]
0
0
Wroclaw
Query!
Country [27]
0
0
Spain
Query!
State/province [27]
0
0
Barcelona
Query!
Country [28]
0
0
Spain
Query!
State/province [28]
0
0
Madrid
Query!
Country [29]
0
0
Spain
Query!
State/province [29]
0
0
Pamplona
Query!
Country [30]
0
0
United Kingdom
Query!
State/province [30]
0
0
Cardiff
Query!
Country [31]
0
0
United Kingdom
Query!
State/province [31]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Jazz Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The
blinded phase only will be described in this record. Participants will receive 1 of 2 doses
of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a
difference between GWP42003-P and placebo in their effect on seizure frequency.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02544763
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02544763
Download to PDF