Tuberous Sclerosis ComplexPhase 3NCT02544763
A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
A Phase 3 study testing GWP42003-P in people with Tuberous Sclerosis Complex and Seizures, run by Jazz Pharmaceuticals at 44 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Tuberous Sclerosis Complex, Seizures
- What is being tested?
- GWP42003-P
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 44 sitesin 6 countries
- Study dates
- 6 Apr 2016to 26 Feb 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
44 sites in 6 countries.
44 sites in 6 countries
United States23 sites
University of Colorado Denver
Aurora, Colorado, 80045
Mid Atlantic Epilepsy & Sleep Centre
Bethesda, Maryland, 20817
UAB Epilepsy Center
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Virginia
Charlottesville, Virginia, 22903
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Texas Scottish Rite Hospital for Children
Dallas, Texas, 75104
Cook Children's Health Care System
Fort Worth, Texas, 76104
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
UCLA-Pediatric Neurology
Los Angeles, California, 90095
WellSpan Paediatric Neurology
Manchester, Pennsylvania, 17345
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Pediatric Neurology
Miami, Florida, 33155
NYU Comprehensive Epilepsy Center
New York, New York, 10016
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Minnesota Epilepsy Group, P.A
Saint Paul, Minnesota, 55102
Paediatric Neurology
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
Washington University School of Medicine
St Louis, Missouri, 63110
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Poland6 sites
Vitamed Gałaj I Cichomski Spółka Jawna
Bydgoszcz
Centrum Medyczne Plejady
Krakow
Wojewódzki Szpital Specjalistyczny im S. K. Wyszyńskiego SPZOZ
Lublin
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego w Warszawie
Warsaw
Centrum Neuropsychiatrii "Neuromed"
Wroclaw
Spain5 sites
Centro Médico Teknon
Barcelona
Clinical Research Unit
Barcelona
Unitat d'Epilèpsia
Barcelona
Hospital Infantil Universitario Niño Jesús
Madrid
Clinica Universidad de Navarra
Pamplona
Australia4 sites
Austin Health
Heidelberg
Royal Brisbane and Women's Hospital
Herston
The Royal Melbourne Hospital
Parkville
Sydney Children's Hospital
Randwick
United Kingdom4 sites
Cardiff and Vale University Local Health Board
Cardiff
Children and Young Adults' Research Unit
Cardiff
NIHR Clinical Research Facility
London
St George's University Hospitals NHS Foundation Trust
London
Netherlands2 sites
Erasmus MC/Sophia Children's Hospital
Rotterdam
UMC Utrecht/ Wilhelmina, Kinderziekenhuis
Utrecht
About this study
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
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.
- Conditions
- Tuberous Sclerosis Complex, Seizures
- Being tested
- GWP42003-P, Placebo
- Medical subject headings
- Tuberous Sclerosis, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GWP42003-PDrug
Also called Cannabidiol, CBD
Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
PlaceboDrug
Yellow oily solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
| Study group | Role | What they receive |
|---|---|---|
| 25 mg/kg/day GWP42003-P | Experimental | 100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening). Receives: Drug: GWP42003-P |
| 50 mg/kg/day GWP42003-P | Experimental | 100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening). Receives: Drug: GWP42003-P |
| Placebo | Placebo comparator | Placebo oral solution matching 100 mg/mL GWP42003-P. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration)
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.
Measured: Baseline; up to Week 16
Secondary outcomes (4)
Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration)
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.
Measured: Baseline; up to Week 16
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
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)."
Measured: Baseline; up to Week 16
Percent Change From Baseline in Total Seizures During the Treatment Period (Maintenance and Titration)
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.
Measured: Baseline; up to Week 16
Number of Participants With Any Severe Treatment-emergent Adverse Event (TEAE)
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).
Measured: up to approximately Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start6 Apr 2016
- Primary completion22 Jan 2019
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tuberous Sclerosis ComplexStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544763
- Sponsor's protocol ID
- GWEP1521 Blinded Phase
- Other IDs
- 2015-002154-12, 2015
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2015
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Burke C, Crossan C, Tyas E, Hemstock M, Lee D, Bowditch S. A Cost-Utility Analysis of Add-On Cannabidiol Versus Usual Care Alone for the Treatment of Seizures Associated with Tuberous Sclerosis Complex in England and Wales. Pharmacoecon Open. 2024 Jul;8(4):611-626. doi: 10.1007/s41669-024-00474-x. Epub 2024 Mar 5.
PubMed 38441854Wu JY, Cock HR, Devinsky O, Joshi C, Miller I, Roberts CM, Sanchez-Carpintero R, Checketts D, Sahebkar F. Time to onset of cannabidiol treatment effect and resolution of adverse events in tuberous sclerosis complex: Post hoc analysis of randomized controlled phase 3 trial GWPCARE6. Epilepsia. 2022 May;63(5):1189-1199. doi: 10.1111/epi.17199. Epub 2022 Mar 4.
PubMed 35175622Thiele EA, Bebin EM, Filloux F, Kwan P, Loftus R, Sahebkar F, Sparagana S, Wheless J. Long-term cannabidiol treatment for seizures in patients with tuberous sclerosis complex: An open-label extension trial. Epilepsia. 2022 Feb;63(2):426-439. doi: 10.1111/epi.17150. Epub 2021 Dec 27.
PubMed 34957550Thiele EA, Bebin EM, Bhathal H, Jansen FE, Kotulska K, Lawson JA, O'Callaghan FJ, Wong M, Sahebkar F, Checketts D, Knappertz V; GWPCARE6 Study Group. Add-on Cannabidiol Treatment for Drug-Resistant Seizures in Tuberous Sclerosis Complex: A Placebo-Controlled Randomized Clinical Trial. JAMA Neurol. 2021 Mar 1;78(3):285-292. doi: 10.1001/jamaneurol.2020.4607.
PubMed 33346789
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02544763
- Acronym / sponsor ID
- GWEP1521 Blinded Phase
- Conditions
- Tuberous Sclerosis Complex, Seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2016 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Posted 23 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25 mg/kg/day GWP42003-P | Experimental | Drug: GWP42003-P100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening). |
| 50 mg/kg/day GWP42003-P | Experimental | Drug: GWP42003-P100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral solution matching 100 mg/mL GWP42003-P. |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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 exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GWP42003-PAlso: Cannabidiol, CBDYellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. | Drug | 25 mg/kg/day GWP42003-P, 50 mg/kg/day GWP42003-P |
| PlaceboYellow oily solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. | Drug | Placebo |
Primary outcome
Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration)
Time frame: Baseline; up to Week 16
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.
4 secondary outcomes
Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration)
Time frame: Baseline; up to Week 16
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
Time frame: Baseline; up to Week 16
Percent Change From Baseline in Total Seizures During the Treatment Period (Maintenance and Titration)
Time frame: Baseline; up to Week 16
Number of Participants With Any Severe Treatment-emergent Adverse Event (TEAE)
Time frame: up to approximately Week 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38441854Burke C, Crossan C, Tyas E, Hemstock M, Lee D, Bowditch S. A Cost-Utility Analysis of Add-On Cannabidiol Versus Usual Care Alone for the Treatment of Seizures Associated with Tuberous Sclerosis Complex in England and Wales. Pharmacoecon Open. 2024 Jul;8(4):611-626. doi: 10.1007/s41669-024-00474-x. Epub 2024 Mar 5.
- Derived from this study: PubMed 35175622Wu JY, Cock HR, Devinsky O, Joshi C, Miller I, Roberts CM, Sanchez-Carpintero R, Checketts D, Sahebkar F. Time to onset of cannabidiol treatment effect and resolution of adverse events in tuberous sclerosis complex: Post hoc analysis of randomized controlled phase 3 trial GWPCARE6. Epilepsia. 2022 May;63(5):1189-1199. doi: 10.1111/epi.17199. Epub 2022 Mar 4.
- Derived from this study: PubMed 34957550Thiele EA, Bebin EM, Filloux F, Kwan P, Loftus R, Sahebkar F, Sparagana S, Wheless J. Long-term cannabidiol treatment for seizures in patients with tuberous sclerosis complex: An open-label extension trial. Epilepsia. 2022 Feb;63(2):426-439. doi: 10.1111/epi.17150. Epub 2021 Dec 27.
- Derived from this study: PubMed 33346789Thiele EA, Bebin EM, Bhathal H, Jansen FE, Kotulska K, Lawson JA, O'Callaghan FJ, Wong M, Sahebkar F, Checketts D, Knappertz V; GWPCARE6 Study Group. Add-on Cannabidiol Treatment for Drug-Resistant Seizures in Tuberous Sclerosis Complex: A Placebo-Controlled Randomized Clinical Trial. JAMA Neurol. 2021 Mar 1;78(3):285-292. doi: 10.1001/jamaneurol.2020.4607.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GWP42003-P in people with Tuberous Sclerosis Complex and Seizures, run by Jazz Pharmaceuticals at 44 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Poland, Spain, Australia, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration) (time frame: Baseline; up to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02544763, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.