Trial · NCT02091206

A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)

NCT02091206, Phase 2, Completed, Jazz Pharmaceuticals; results first posted 2018-07-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1). Trials, record NCT02091206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02091206

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)
NCT number: NCT02091206
Status: Completed
Phases: Phase 2
Enrollment: 34 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Epilepsy, Dravet Syndrome
Interventions: GWP42003-P 5 mg/kg/day Dose, Placebo control, GWP42003-P 10 mg/kg/day Dose, GWP42003-P 20 mg/kg/day Dose
First posted: 2014-03-19
Last updated: 2022-09-28
Other registries' IDs: eudract:2014-002941-23
Results first posted: 2018-07-19
Limitations and caveats: Analytical issues for 7-OH-CBD related to reference material batch used during analysis. Data are qualitative.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)	Baseline (Day 1) through Safety follow-up visit (Day 60)	A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of IMP. If an AE had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through the Safety Follow-up Visit (Day 60) is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Adverse Events module.
Secondary	Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22	Predose and 2-6 hours postdose on Days 1 and 22	AUC0-t for CBD and its major metabolites, 6-hydroxy-CBD (6-OH-CBD), 7-hydroxy-CBD (7-OH-CBD), and 7-carboxy-CBD (7-COOH-CBD) were calculated using blood samples collected before and after IMP dosing on Days 1 and 22. One sample was collected predose, 2 to 3 hours postdose, and 4 to 6 hours postdose for CBD and its metabolites. Results are presented for participants who received GWP42003-P at 5, 10, or 20 mg/kg/day during the study and for participants with a numeric result for the given evaluation.
Secondary	Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations	Predose on Days 1 and 22	Plasma concentrations of CLB and N-CLB were measured on Days 1 and 22. Participants were instructed to take their daily dose of CLB 2 hours prior to the anticipated pre-IMP blood specimen collection on both days. Blood samples were collected prior to administration of IMP. Results are presented for a subgroup of participants who took CLB during the study and had PK samples analyzed at both PK sampling visits (Days 1 and 22).

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)	Baseline (Day 1) through Safety follow-up visit (Day 60)	Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22	Predose and 2-6 hours postdose on Days 1 and 22	Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	hours * nanograms/mL	GEOMETRIC_MEAN
SECONDARY	Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations	Predose on Days 1 and 22	Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	percent change	NUMBER

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)	GWP42003-P 5 mg/kg/Day Dose		2		Participants
Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)	GWP42003-P 10 mg/kg/Day Dose		1		Participants
Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)	GWP42003-P 20 mg/kg/Day Dose		0		Participants
Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)	Placebo		1		Participants
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22	GWP42003-P 5 mg/kg/Day Dose	Day 1 CBD	70.61	Geometric Coefficient of Variation 20.38	hours * nanograms/mL
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22	GWP42003-P 10 mg/kg/Day Dose	Day 1 CBD	66.35	Geometric Coefficient of Variation 120.8	hours * nanograms/mL
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22	GWP42003-P 20 mg/kg/Day Dose	Day 1 CBD	73.69	Geometric Coefficient of Variation 96.64	hours * nanograms/mL
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22	GWP42003-P 5 mg/kg/Day Dose	Day 22 CBD	240.8	Geometric Coefficient of Variation 100.8	hours * nanograms/mL
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22	GWP42003-P 10 mg/kg/Day Dose	Day 22 CBD	721.8	Geometric Coefficient of Variation 79.92	hours * nanograms/mL
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22	GWP42003-P 20 mg/kg/Day Dose	Day 22 CBD	962.6	Geometric Coefficient of Variation 93.43	hours * nanograms/mL

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow28

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	GWP42003-P 5 mg/kg/Day Dose	10
Treatment Period	STARTED	GWP42003-P 10 mg/kg/Day Dose	8
Treatment Period	STARTED	GWP42003-P 20 mg/kg/Day Dose	9
Treatment Period	STARTED	Placebo	7
Treatment Period	Safety Analysis Set	GWP42003-P 5 mg/kg/Day Dose	10
Treatment Period	Safety Analysis Set	GWP42003-P 10 mg/kg/Day Dose	8
Treatment Period	Safety Analysis Set	GWP42003-P 20 mg/kg/Day Dose	9
Treatment Period	Safety Analysis Set	Placebo	7
Treatment Period	COMPLETED	GWP42003-P 5 mg/kg/Day Dose	10
Treatment Period	COMPLETED	GWP42003-P 10 mg/kg/Day Dose	7

1 to 10 of 28Source ClinicalTrials.gov

See all 28 participant flow

Adverse events236

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
other	Diplopia	Eye disorders	GWP42003-P 5 mg/kg/Day Dose	0	10
other	Diplopia	Eye disorders	GWP42003-P 10 mg/kg/Day Dose	0	8
other	Diplopia	Eye disorders	GWP42003-P 20 mg/kg/Day Dose	1	9
other	Diplopia	Eye disorders	Placebo	0	7
other	Abdominal Pain Upper	Gastrointestinal disorders	GWP42003-P 5 mg/kg/Day Dose	0	10
other	Abdominal Pain Upper	Gastrointestinal disorders	GWP42003-P 10 mg/kg/Day Dose	0	8
other	Abdominal Pain Upper	Gastrointestinal disorders	GWP42003-P 20 mg/kg/Day Dose	2	9
other	Abdominal Pain Upper	Gastrointestinal disorders	Placebo	0	7
other	Constipation	Gastrointestinal disorders	GWP42003-P 5 mg/kg/Day Dose	1	10
other	Constipation	Gastrointestinal disorders	GWP42003-P 10 mg/kg/Day Dose	0	8

1 to 10 of 236Source ClinicalTrials.gov

See all 236 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GWP42003-P 5 mg/kg/Day Dose
Total, all-cause mortality	GWP42003-P 10 mg/kg/Day Dose
Total, all-cause mortality	GWP42003-P 20 mg/kg/Day Dose
Total, all-cause mortality	Placebo
Total, other adverse events	GWP42003-P 5 mg/kg/Day Dose	8	10
Total, other adverse events	GWP42003-P 10 mg/kg/Day Dose	5	8
Total, other adverse events	GWP42003-P 20 mg/kg/Day Dose	7	9
Total, other adverse events	Placebo	6	7
Total, serious adverse events	GWP42003-P 5 mg/kg/Day Dose	1	10
Total, serious adverse events	GWP42003-P 10 mg/kg/Day Dose	2	8

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29540584	BACKGROUND

Source PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02091206

GET https://conductscience.org/api/trials/v1/NCT02091206/results?page=2

API reference For AI assistants