Trial · NCT02224560
Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
NCT02224560, 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. Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults. Trials, record NCT02224560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02224560
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
- NCT number
- NCT02224560
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 225 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Epilepsy, Lennox Gastaut Syndrome
- Interventions
- GWP42003-P, Placebo control
- First posted
- 2014-08-25
- Last updated
- 2022-09-28
- Other registries' IDs
- eudract:2014-002940-42
- 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) x 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) x 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 (S/CGIC) Assessment | 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: Received at least 1 dose of IMP with 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: Received at least 1 dose of IMP with 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: Received at least 1 dose of IMP with 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 (S/CGIC) Assessment | Baseline to Last Visit (Day 99) or ET | ITT Analysis Set: Received at least 1 dose of IMP with 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 group30
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 | -41.86 | Inter-Quartile Range -72.4 to -1.3 | percentage change | |
| Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period | GWP42003-P 10 mg/kg/Day Dose | -37.16 | Inter-Quartile Range -63.8 to -5.6 | percentage change | |
| Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period | Placebo | -17.17 | Inter-Quartile Range -37.1 to 0.9 | 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 | 30 | Participants | ||
| Number Of Participants With A ≥50% Reduction From Baseline In Drop Seizure Frequency During The Treatment Period | GWP42003-P 10 mg/kg/Day Dose | 26 | Participants | ||
| Number Of Participants With A ≥50% Reduction From Baseline In Drop Seizure Frequency During The Treatment Period | Placebo | 11 | Participants | ||
| Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period | GWP42003-P 20 mg/kg/Day Dose | -38.40 | Inter-Quartile Range -64.6 to -0.7 | percentage change | |
| Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period | GWP42003-P 10 mg/kg/Day Dose | -36.44 | Inter-Quartile Range -64.5 to -10.8 | percentage change | |
| Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period | Placebo | -18.47 | Inter-Quartile Range -39.0 to 0.5 | percentage change | |
| Subject/Caregiver Global Impression Of Change (S/CGIC) Assessment | GWP42003-P 20 mg/kg/Day Dose | Very Much Improved | 6 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow15
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 | 76 | |
| Overall Study | STARTED | GWP42003-P 10 mg/kg/Day Dose | 73 | |
| Overall Study | STARTED | Placebo | 76 | |
| Overall Study | Safety Analysis Set | GWP42003-P 20 mg/kg/Day Dose | 82 | |
| Overall Study | Safety Analysis Set | GWP42003-P 10 mg/kg/Day Dose | 67 | |
| Overall Study | Safety Analysis Set | Placebo | 76 | |
| Overall Study | Intent to Treat (ITT) Analysis Set | GWP42003-P 20 mg/kg/Day Dose | 76 | |
| Overall Study | Intent to Treat (ITT) Analysis Set | GWP42003-P 10 mg/kg/Day Dose | 73 | |
| Overall Study | Intent to Treat (ITT) Analysis Set | Placebo | 76 | |
| Overall Study | COMPLETED | GWP42003-P 20 mg/kg/Day Dose | 67 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events141
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-Safety Analysis Set | 12 | 82 | |
| other | Diarrhoea | Gastrointestinal disorders | GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set | 7 | 67 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-Safety Analysis Set | 6 | 76 | |
| other | Vomiting | Gastrointestinal disorders | GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set | 10 | 82 | |
| other | Vomiting | Gastrointestinal disorders | GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set | 4 | 67 | |
| other | Vomiting | Gastrointestinal disorders | Placebo-Safety Analysis Set | 9 | 76 | |
| other | Pyrexia | General disorders | GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set | 9 | 82 | |
| other | Pyrexia | General disorders | GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set | 6 | 67 | |
| other | Pyrexia | General disorders | Placebo-Safety Analysis Set | 12 | 76 | |
| other | Fatigue | General disorders | GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set | 8 | 82 |
1 to 10 of 141Source ClinicalTrials.gov
See all 141 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set | ||
| Total, all-cause mortality | GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set | ||
| Total, all-cause mortality | Placebo-Safety Analysis Set | ||
| Total, other adverse events | GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set | 63 | 82 |
| Total, other adverse events | GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set | 36 | 67 |
| Total, other adverse events | Placebo-Safety Analysis Set | 40 | 76 |
| Total, serious adverse events | GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set | 13 | 82 |
| Total, serious adverse events | GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set | 13 | 67 |
| Total, serious adverse events | Placebo-Safety Analysis Set | 8 | 76 |
Source ClinicalTrials.gov
Papers6
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/NCT02224560
GET https://conductscience.org/api/trials/v1/NCT02224560/results?page=2