Trial · NCT02091375
Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)
NCT02091375, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2018-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1). Trials, record NCT02091375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02091375
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)
- NCT number
- NCT02091375
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 120 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Epilepsy, Dravet Syndrome
- Interventions
- GWP42003-P 20 mg/kg/day Dose, Placebo control
- First posted
- 2014-03-19
- Last updated
- 2022-09-28
- Other registries' IDs
- eudract:2014-002941-23
- Results first posted
- 2018-07-20
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline In Convulsive Seizure Frequency During The Treatment Period | Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET) | Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. 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 Convulsive Seizure Frequency During The Treatment Period | Baseline to EOT (Day 99) or ET | Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. |
| Secondary | Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period | Baseline to EOT (Day 99) or ET | Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. |
| Secondary | Percentage Change From Baseline In Non-Convulsive Seizure Frequency During The Treatment Period | Baseline to EOT (Day 99) or ET | Non-convulsive seizures (myoclonic, partial, or absence) were recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Only participants with non-convulsive seizures during the baseline period were included. Negative percentages show an improvement from baseline. |
| Secondary | Caregiver Global Impression Of Change In Seizure Duration (CGICSD) | Baseline to EOT (Day 99) or ET | Seizure duration was assessed qualitatively using the CGICSD. Caregivers were asked "Since the patient started treatment, please assess the average duration of the patient's seizures (comparing their condition now to their condition before treatment)"; responses included decrease, no change, or increase in average duration. For each seizure type, only participants with at least 1 seizure for the corresponding seizure type, reported at any time during the study, were included. |
| Secondary | Number Of Participants Using Rescue Medication | Baseline to EOT (Day 99) or ET | The use of rescue medication was recorded by the participant or caregiver using a paper diary. |
| Secondary | Number Of Participants With Inpatient Hospitalizations Due To Epilepsy | Baseline to Safety Follow-up (Day 137) | Inpatient hospitalizations due to epilepsy were recorded by the participant or caregiver and through the serious adverse events (SAE) reporting process. |
| Secondary | Change From Baseline In Sleep Disruption 0 To 10 Numerical Rating Scale (0 to 10 NRS) Score | Baseline to Last Visit (Day 99) or ET | The sleep disruption 0 to 10 NRS questionnaire was completed by the participant's caregiver. The caregiver was asked 'On a scale of '0 to 10', please indicate the number that best describes your child's sleep disruption in the last week.' The markers ranged from 0 = 'slept extremely well' to 10 = 'unable to sleep at all'. The change from baseline in the sleep disruption 0 to 10 numerical rating scale score was analyzed using an analysis of covariance (ANCOVA) model with baseline and age group (2 to 5 years, 6 to 12 years and 13 to 18 years) as covariates and treatment group as a fixed factor. A negative change from baseline represents an improvement in sleep. 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. |
| Secondary | Change From Baseline In Epworth Sleepiness Scale (ESS) Score | Baseline to Last Visit (Day 99) or ET | The ESS questionnaire was completed by the participant's caregiver. The change from baseline in the ESS score was analyzed using an ANCOVA model with baseline and age group (2 to 5 years, 6- to 2 years and 13 to 18 years) as covariates and treatment group as a fixed factor. The total score was the sum of the 8 item-scores and ranged from 0 to 24. A higher total score represents greater levels of daytime sleepiness. |
| Secondary | Change From Baseline In Quality Of Life In Childhood Epilepsy (QOLCE) Score | Baseline to EOT (Day 99) or ET | The QOLCE questionnaire was completed by the parent or caregiver of participants aged 4 years and above. The change from baseline in the overall quality of life score was analyzed using an ANCOVA model with baseline and age group (2 to 5 years, 6 to 12 years and 13 to 18 years) as covariates and treatment group as a fixed factor. Zero represents the lowest or poorest category and 100 represents the highest level of functioning. The overall quality of life score was calculated by taking the mean of the subscale scores. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Convulsive Seizure Frequency During The Treatment Period | Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET) | ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures. | percent change | MEDIAN |
| SECONDARY | Number Of Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period | Baseline to EOT (Day 99) or ET | ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period | Baseline to EOT (Day 99) or ET | ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Change From Baseline In Non-Convulsive Seizure Frequency During The Treatment Period | Baseline to EOT (Day 99) or ET | ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures. | percent change | MEDIAN |
| SECONDARY | Caregiver Global Impression Of Change In Seizure Duration (CGICSD) | Baseline to EOT (Day 99) or ET | ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number Of Participants Using Rescue Medication | Baseline to EOT (Day 99) or ET | Safety Analysis Set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the actual treatment they received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number Of Participants With Inpatient Hospitalizations Due To Epilepsy | Baseline to Safety Follow-up (Day 137) | ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures. | participants | NUMBER |
| SECONDARY | Change From Baseline In Sleep Disruption 0 To 10 Numerical Rating Scale (0 to 10 NRS) Score | Baseline to Last Visit (Day 99) or ET | ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline In Epworth Sleepiness Scale (ESS) Score | Baseline to Last Visit (Day 99) or ET | ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline In Quality Of Life In Childhood Epilepsy (QOLCE) Score | Baseline to EOT (Day 99) or ET | ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group98
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 Convulsive Seizure Frequency During The Treatment Period | GWP42003-P 20 mg/kg/Day Dose | -38.94 | Inter-Quartile Range -69.53 to -4.83 | percent change | |
| Percentage Change From Baseline In Convulsive Seizure Frequency During The Treatment Period | Placebo | -13.29 | Inter-Quartile Range -52.53 to 20.20 | percent change | |
| Number Of Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period | GWP42003-P 20 mg/kg/Day Dose | 26 | Participants | ||
| Number Of Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period | Placebo | 16 | Participants | ||
| Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period | GWP42003-P 20 mg/kg/Day Dose | ≥25% Reduction | 38 | Participants | |
| Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period | Placebo | ≥25% Reduction | 26 | Participants | |
| Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period | GWP42003-P 20 mg/kg/Day Dose | ≥75% Reduction | 14 | Participants | |
| Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period | Placebo | ≥75% Reduction | 7 | Participants | |
| Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period | GWP42003-P 20 mg/kg/Day Dose | 100% Reduction | 3 | Participants | |
| Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period | Placebo | 100% Reduction | 0 | Participants |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 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 | 61 | |
| Overall Study | STARTED | Placebo | 59 | |
| Overall Study | Safety Analysis Set | GWP42003-P 20 mg/kg/Day Dose | 61 | |
| Overall Study | Safety Analysis Set | Placebo | 59 | |
| Overall Study | Intention to Treat (ITT) Analysis Set | GWP42003-P 20 mg/kg/Day Dose | 61 | |
| Overall Study | Intention to Treat (ITT) Analysis Set | Placebo | 59 | |
| Overall Study | COMPLETED | GWP42003-P 20 mg/kg/Day Dose | 52 | |
| Overall Study | COMPLETED | Placebo | 56 | |
| Overall Study | NOT COMPLETED | GWP42003-P 20 mg/kg/Day Dose | 9 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events80
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 | 19 | 61 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 59 | |
| other | Vomiting | Gastrointestinal disorders | GWP42003-P 20 mg/kg/Day Dose | 9 | 61 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 3 | 59 | |
| other | Pyrexia | General disorders | GWP42003-P 20 mg/kg/Day Dose | 9 | 61 | |
| other | Pyrexia | General disorders | Placebo | 5 | 59 | |
| other | Fatigue | General disorders | GWP42003-P 20 mg/kg/Day Dose | 11 | 61 | |
| other | Fatigue | General disorders | Placebo | 2 | 59 | |
| other | Upper respiratory tract infection | Infections and infestations | GWP42003-P 20 mg/kg/Day Dose | 7 | 61 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 5 | 59 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 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 | 46 | 61 |
| Total, other adverse events | Placebo | 28 | 59 |
| Total, serious adverse events | GWP42003-P 20 mg/kg/Day Dose | 10 | 61 |
| Total, serious adverse events | Placebo | 3 | 59 |
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 comparisons3
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 Convulsive Seizure Frequency During The Treatment Period | Trial comparisons |
| GWP42003-P 20 mg/kg/Day Dose vs Placebo: Number Of Participants Using Rescue Medication | 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/NCT02091375
GET https://conductscience.org/api/trials/v1/NCT02091375/results?page=2