Trial · NCT02544763
A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
NCT02544763, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2020-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6). Trials, record NCT02544763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02544763
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
- NCT number
- NCT02544763
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 224 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Tuberous Sclerosis Complex, Seizures
- Interventions
- GWP42003-P, Placebo
- First posted
- 2015-09-09
- Last updated
- 2022-09-28
- Other registries' IDs
- eudract:2015-002154-12
- Results first posted
- 2020-09-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration) | 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. |
| Secondary | Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration) | Baseline; up to Week 16 | 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. |
| Secondary | 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 | Baseline; up to Week 16 | 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)." |
| Secondary | Percent Change From Baseline in Total Seizures During the Treatment Period (Maintenance and Titration) | Baseline; up to Week 16 | 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. |
| Secondary | Number of Participants With Any Severe Treatment-emergent Adverse Event (TEAE) | up to approximately Week 22 | 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). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration) | Baseline; up to Week 16 | Intent-to-Treat (ITT) Analysis Set: all participants who were randomized and dosed with investigational medicinal product (IMP) in the trial and had post-Baseline efficacy data. Participant data were analyzed according to the treatment group to which they were randomized. | percent change | MEDIAN |
| SECONDARY | Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration) | Baseline; up to Week 16 | ITT Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Baseline; up to Week 16 | ITT Analysis Set. Only participants with available data were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in Total Seizures During the Treatment Period (Maintenance and Titration) | Baseline; up to Week 16 | ITT Analysis Set | percent change | MEAN |
| SECONDARY | Number of Participants With Any Severe Treatment-emergent Adverse Event (TEAE) | up to approximately Week 22 | Safety Analysis Set: all participants randomized to treatment who received at least 1 dose of IMP | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration) | GWP42003-P 25 mg/kg/Day | -43.36 | Inter-Quartile Range -67.8 to -13.6 | percent change | |
| Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration) | GWP42003-P 50 mg/kg/Day | -36.55 | Inter-Quartile Range -67.0 to -5.5 | percent change | |
| Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration) | Placebo | -20.08 | Inter-Quartile Range -47.1 to 3.1 | percent change | |
| Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration) | GWP42003-P 25 mg/kg/Day | Responders | 27 | Participants | |
| Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration) | GWP42003-P 50 mg/kg/Day | Responders | 29 | Participants | |
| Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration) | Placebo | Responders | 17 | Participants | |
| Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration) | GWP42003-P 25 mg/kg/Day | Non-responders | 48 | Participants | |
| Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration) | GWP42003-P 50 mg/kg/Day | Non-responders | 44 | Participants | |
| Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration) | Placebo | Non-responders | 59 | Participants | |
| 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 | GWP42003-P 25 mg/kg/Day | Caregiver | 3.0 | Standard Deviation 1.34 | units on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GWP42003-P 25 mg/kg/Day | 75 | |
| Overall Study | STARTED | GWP42003-P 50 mg/kg/Day | 73 | |
| Overall Study | STARTED | Placebo | 76 | |
| Overall Study | COMPLETED | GWP42003-P 25 mg/kg/Day | 65 | |
| Overall Study | COMPLETED | GWP42003-P 50 mg/kg/Day | 61 | |
| Overall Study | COMPLETED | Placebo | 75 | |
| Overall Study | NOT COMPLETED | GWP42003-P 25 mg/kg/Day | 10 | |
| Overall Study | NOT COMPLETED | GWP42003-P 50 mg/kg/Day | 12 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events291
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | GWP42003-P 25 mg/kg/Day | 5 | 75 | |
| other | Anaemia | Blood and lymphatic system disorders | GWP42003-P 50 mg/kg/Day | 3 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 76 | |
| other | Ear pain | Ear and labyrinth disorders | GWP42003-P 25 mg/kg/Day | 2 | 75 | |
| other | Ear pain | Ear and labyrinth disorders | GWP42003-P 50 mg/kg/Day | 1 | 73 | |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 0 | 76 | |
| other | Abdominal pain upper | Gastrointestinal disorders | GWP42003-P 25 mg/kg/Day | 0 | 75 | |
| other | Abdominal pain upper | Gastrointestinal disorders | GWP42003-P 50 mg/kg/Day | 3 | 73 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 76 | |
| other | Constipation | Gastrointestinal disorders | GWP42003-P 25 mg/kg/Day | 8 | 75 |
1 to 10 of 291Source ClinicalTrials.gov
See all 291 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GWP42003-P 25 mg/kg/Day | 0 | 75 |
| Total, all-cause mortality | GWP42003-P 50 mg/kg/Day | 0 | 73 |
| Total, all-cause mortality | Placebo | 0 | 76 |
| Total, other adverse events | GWP42003-P 25 mg/kg/Day | 66 | 75 |
| Total, other adverse events | GWP42003-P 50 mg/kg/Day | 71 | 73 |
| Total, other adverse events | Placebo | 68 | 76 |
| Total, serious adverse events | GWP42003-P 25 mg/kg/Day | 16 | 75 |
| Total, serious adverse events | GWP42003-P 50 mg/kg/Day | 10 | 73 |
| Total, serious adverse events | Placebo | 2 | 76 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02544763
GET https://conductscience.org/api/trials/v1/NCT02544763/results?page=2