Trial · NCT02544750
An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
NCT02544750, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2022-07-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6). Trials, record NCT02544750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02544750
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
- NCT number
- NCT02544750
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 199 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Tuberous Sclerosis Complex, Seizures
- Interventions
- GWP42003-P
- First posted
- 2015-09-09
- Last updated
- 2022-07-14
- Other registries' IDs
- eudract:2015-002154-12
- Results first posted
- 2022-07-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | OLE Day 1 up to 4 years | An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. An AE that started, or worsened in severity or seriousness, following the first dose of IMP was considered a TEAE. A serious AE was defined as any AE that results in any of the following outcomes: death, life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or cancer, any other experience that suggests a significant hazard, contraindication, side effect or precaution that may require medical or surgical intervention to prevent one of the outcomes listed above, or an event that changes the risk/benefit ratio of the study. |
| Primary | Number of Participants With Any TEAE, by Severity | OLE Day 1 up to 4 years | An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. An AE that started, or worsened in severity or seriousness, following the first dose of IMP was considered a TEAE. Grade 1 (Mild) is defined as asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate) is defined as minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living (ADL). Grade 3 (Severe) is defined as medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. |
| Secondary | Percent Change From Baseline in the Number of TSC-associated Seizures During the OLE Treatment Period | OLE Day 1 up to 4 years | TSC-associated seizures include: focal motor seizures without impairment of consciousness or awareness; focal seizures with impairment of consciousness or awareness; focal seizures evolving to bilateral generalized convulsive seizures and tonic-clonic, tonic, clonic or atonic seizures. A negative percent change from baseline indicates improvement. |
| Secondary | Number of Participants Considered Treatment Responders During the OLE Treatment Period | OLE Day 1 up to 4 years | Treatment responders were defined as those participants with a ≥50% reduction from baseline in TSC-associated seizure frequency, during the treatment period, for participants who had not withdrawn from the trial during the treatment period. 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 were countable. Participants who withdrew from the trial during the treatment period were considered non-responders. |
| Secondary | Caregiver Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC) Score During the OLE Treatment Period | OLE Day 1 and up to 4 years | 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)." The average CGIC and SGIC scores are being reported, with higher values indicating worse condition. |
| Secondary | Percent Change From Baseline in Total Seizure Frequency During the OLE Treatment Period | OLE Day 1 up to 4 years | Total seizures included all seizure types, eg. combination of TSC-associated and other seizures. 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 were countable. A negative percent change from baseline indicates improvement in total seizure frequency. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | OLE Day 1 up to 4 years | Adverse events were assessed in the OLE Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any TEAE, by Severity | OLE Day 1 up to 4 years | Adverse events were assessed in the OLE Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in the Number of TSC-associated Seizures During the OLE Treatment Period | OLE Day 1 up to 4 years | TSC-associated seizures were assessed in the OLE Safety Analysis Set. | percent change | MEDIAN |
| SECONDARY | Number of Participants Considered Treatment Responders During the OLE Treatment Period | OLE Day 1 up to 4 years | Treatment responders were assessed in the OLE Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Caregiver Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC) Score During the OLE Treatment Period | OLE Day 1 and up to 4 years | Caregiver Global Impression of Change and Subject Global Impression of Change were assessed in the OLE Safety Analysis Set in participants with available data. | score on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in Total Seizure Frequency During the OLE Treatment Period | OLE Day 1 up to 4 years | Total seizure frequency was assessed in the OLE Safety Analysis Set. | percent change | MEDIAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | GWP42003-P (Double-blind Phase) | Any TEAE | 117 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | Placebo (Double-blind Phase) | Any TEAE | 75 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | GWP42003-P (Double-blind Phase) | Any treatment-related TEAE | 80 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | Placebo (Double-blind Phase) | Any treatment-related TEAE | 60 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | GWP42003-P (Double-blind Phase) | Any TEAE leading to permanent discontinuation of IMP | 11 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | Placebo (Double-blind Phase) | Any TEAE leading to permanent discontinuation of IMP | 7 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | GWP42003-P (Double-blind Phase) | Any treatment-related TEAE leading to permanent discontinuation of IMP | 9 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | Placebo (Double-blind Phase) | Any treatment-related TEAE leading to permanent discontinuation of IMP | 7 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | GWP42003-P (Double-blind Phase) | Any serious TEAE | 38 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | Placebo (Double-blind Phase) | Any serious TEAE | 18 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GWP42003-P (Double-blind Phase) | 124 | |
| Overall Study | STARTED | Placebo (Double-blind Phase) | 75 | |
| Overall Study | COMPLETED | GWP42003-P (Double-blind Phase) | 22 | |
| Overall Study | COMPLETED | Placebo (Double-blind Phase) | 12 | |
| Overall Study | NOT COMPLETED | GWP42003-P (Double-blind Phase) | 102 | |
| Overall Study | NOT COMPLETED | Placebo (Double-blind Phase) | 63 |
Source ClinicalTrials.gov
Adverse events312
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 | Placebo (Double-blind Phase) | 4 | 124 | |
| other | Anaemia | Blood and lymphatic system disorders | GWP42003-P (Double-blind Phase) | 2 | 75 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo (Double-blind Phase) | 4 | 124 | |
| other | Abdominal pain | Gastrointestinal disorders | GWP42003-P (Double-blind Phase) | 3 | 75 | |
| other | Constipation | Gastrointestinal disorders | Placebo (Double-blind Phase) | 12 | 124 | |
| other | Constipation | Gastrointestinal disorders | GWP42003-P (Double-blind Phase) | 9 | 75 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (Double-blind Phase) | 50 | 124 | |
| other | Diarrhoea | Gastrointestinal disorders | GWP42003-P (Double-blind Phase) | 43 | 75 | |
| other | Nausea | Gastrointestinal disorders | Placebo (Double-blind Phase) | 3 | 124 | |
| other | Nausea | Gastrointestinal disorders | GWP42003-P (Double-blind Phase) | 4 | 75 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Double-blind Phase) | 1 | 124 |
| Total, all-cause mortality | GWP42003-P (Double-blind Phase) | 0 | 75 |
| Total, other adverse events | Placebo (Double-blind Phase) | 117 | 124 |
| Total, other adverse events | GWP42003-P (Double-blind Phase) | 75 | 75 |
| Total, serious adverse events | Placebo (Double-blind Phase) | 38 | 124 |
| Total, serious adverse events | GWP42003-P (Double-blind Phase) | 18 | 75 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GWP42003-P (Double-blind Phase) vs Placebo (Double-blind Phase): deaths from any cause | Trial comparisons |
| GWP42003-P (Double-blind Phase) vs Placebo (Double-blind Phase): serious adverse events | Trial comparisons |
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/NCT02544750
GET https://conductscience.org/api/trials/v1/NCT02544750/results?page=2