Trial · NCT02224690
A 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
NCT02224690, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2018-07-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 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. Trials, record NCT02224690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02224690
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 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
- NCT number
- NCT02224690
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 171 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Epilepsy, Lennox-Gastaut Syndrome
- Interventions
- GWP42003-P 20 mg/kg/day Dose, Placebo
- First posted
- 2014-08-25
- Last updated
- 2022-09-28
- Other registries' IDs
- eudract:2014-002941-23
- Results first posted
- 2018-07-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period | Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET) | Drop seizures were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Drop seizures were defined as the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in the IVRS. Percentage change from baseline was calculated as: (frequency during the treatment period - frequency during baseline/frequency during baseline) \* 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) \*28. Baseline included all available data prior to Day 1 (28-day average). Negative percentages show an improvement from baseline. |
| Secondary | Number Of Participants With a ≥50% Reduction From Baseline in Drop Seizure Frequency During The Treatment Period | Baseline to EOT (Day 99) or ET | Drop seizures were recorded by the participant or caregiver using an IVRS diary. Drop seizures included the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in IVRS. Percentage change from baseline was calculated as per the primary outcome measure. |
| Secondary | Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period | Baseline to EOT (Day 99) or ET | Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial and absence seizures) recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Negative percentages show an improvement from baseline. |
| Secondary | Subject/Caregiver Global Impression Of Change Assessment (S/CGIC) | Baseline to Last Visit (Day 99) or ET | The S/CGIC was used to assess the participant's overall condition on a 7-point scale, using the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse" (1 = very much improved; 7 = very much worse). On Day 1 (prior to starting IMP), the caregiver was asked to write a brief description of the participant's overall condition as a memory aid for the S/CGIC questionnaire at subsequent visits. If both a CGIC and SGIC were completed then the CGIC was used; if only a CGIC was completed then the CGIC was used; if only a SGIC was completed then the SGIC was used. Last visit for endpoints assessed at clinic visits was defined as the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant's last evaluation was performed. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period | Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET) | ITT Analysis Set: All randomized participants who received at least 1 dose of IMP and had at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized. | percentage change | MEDIAN |
| SECONDARY | Number Of Participants With a ≥50% Reduction From Baseline in Drop Seizure Frequency During The Treatment Period | Baseline to EOT (Day 99) or ET | ITT Analysis Set: All randomized participants who received at least 1 dose of IMP and had at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period | Baseline to EOT (Day 99) or ET | ITT Analysis Set: All randomized participants who received at least 1 dose of IMP and had at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized. | percentage change | MEDIAN |
| SECONDARY | Subject/Caregiver Global Impression Of Change Assessment (S/CGIC) | Baseline to Last Visit (Day 99) or ET | ITT Analysis Set: All randomized participants who received at least 1 dose of IMP and had at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period | GWP42003-P 20 mg/kg/Day Dose | -43.90 | Inter-Quartile Range -69.62 to 1.93 | percentage change | |
| Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period | Placebo | -21.80 | Inter-Quartile Range -45.72 to 1.74 | percentage change | |
| Number Of Participants With a ≥50% Reduction From Baseline in Drop Seizure Frequency During The Treatment Period | GWP42003-P 20 mg/kg/Day Dose | 38 | Participants | ||
| Number Of Participants With a ≥50% Reduction From Baseline in Drop Seizure Frequency During The Treatment Period | Placebo | 20 | Participants | ||
| Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period | GWP42003-P 20 mg/kg/Day Dose | -41.24 | Inter-Quartile Range -62.85 to -13.00 | percentage change | |
| Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period | Placebo | -13.70 | Inter-Quartile Range -45.00 to 7.27 | percentage change | |
| Subject/Caregiver Global Impression Of Change Assessment (S/CGIC) | GWP42003-P 20 mg/kg/Day Dose | Very Much Improved | 15 | Participants | |
| Subject/Caregiver Global Impression Of Change Assessment (S/CGIC) | Placebo | Very Much Improved | 5 | Participants | |
| Subject/Caregiver Global Impression Of Change Assessment (S/CGIC) | GWP42003-P 20 mg/kg/Day Dose | Much Improved | 14 | Participants | |
| Subject/Caregiver Global Impression Of Change Assessment (S/CGIC) | Placebo | Much Improved | 9 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GWP42003-P 20 mg/kg/Day Dose | 86 | |
| Overall Study | STARTED | Placebo | 85 | |
| Overall Study | Safety Analysis Set | GWP42003-P 20 mg/kg/Day Dose | 86 | |
| Overall Study | Safety Analysis Set | Placebo | 85 | |
| Overall Study | Intent to Treat (ITT) Analysis Set | GWP42003-P 20 mg/kg/Day Dose | 86 | |
| Overall Study | Intent to Treat (ITT) Analysis Set | Placebo | 85 | |
| Overall Study | COMPLETED | GWP42003-P 20 mg/kg/Day Dose | 72 | |
| Overall Study | COMPLETED | Placebo | 84 | |
| Overall Study | NOT COMPLETED | GWP42003-P 20 mg/kg/Day Dose | 14 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events102
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 | Diarrhoea | Gastrointestinal disorders | GWP42003-P 20 mg/kg/Day Dose | 16 | 86 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 7 | 85 | |
| other | Vomiting | Gastrointestinal disorders | GWP42003-P 20 mg/kg/Day Dose | 8 | 86 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 14 | 85 | |
| other | Constipation | Gastrointestinal disorders | GWP42003-P 20 mg/kg/Day Dose | 5 | 86 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 4 | 85 | |
| other | Pyrexia | General disorders | GWP42003-P 20 mg/kg/Day Dose | 11 | 86 | |
| other | Pyrexia | General disorders | Placebo | 7 | 85 | |
| other | Fatigue | General disorders | GWP42003-P 20 mg/kg/Day Dose | 5 | 86 | |
| other | Fatigue | General disorders | Placebo | 2 | 85 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GWP42003-P 20 mg/kg/Day Dose | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | GWP42003-P 20 mg/kg/Day Dose | 53 | 86 |
| Total, other adverse events | Placebo | 43 | 85 |
| Total, serious adverse events | GWP42003-P 20 mg/kg/Day Dose | 20 | 86 |
| Total, serious adverse events | Placebo | 4 | 85 |
Source ClinicalTrials.gov
Papers5
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 20 mg/kg/Day Dose vs Placebo: Number Of Participants With a ≥50% Reduction From Baseline in Drop Seizure Frequency During The Treatment Period | Trial comparisons |
| GWP42003-P 20 mg/kg/Day Dose vs Placebo: 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/NCT02224690
GET https://conductscience.org/api/trials/v1/NCT02224690/events?page=2