Trial · NCT02953548

Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)

NCT02953548, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2020-07-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7). Trials, record NCT02953548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02953548

On this page

Trial

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

Title: Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)
NCT number: NCT02953548
Status: Completed
Phases: Phase 3
Enrollment: 9 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Infantile Spasms
Interventions: GWP42003-P
First posted: 2016-11-02
Last updated: 2022-09-02
Other registries' IDs: eudract:2015-004904-50
Results first posted: 2020-07-23
Limitations and caveats: This study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment, and the Pivotal Phase was not initiated. Participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year.

Source ClinicalTrials.gov

Registered outcomes17

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs)	From signing of informed consent up to Day 15	TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
Primary	Number of Participants With Any Low or High Hematology Laboratory Parameter Value	Day 4 and Day 15
Primary	Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value	Day 4 and Day 15
Primary	Number of Participant With Any Clinically Relevant Urinalysis Parameter Value	Day 4 and Day 15	Clinical relevance was determined by the investigator.
Primary	Number of Participants With Clinically Significant Electrocardiogram Findings	From signing of informed consent up to Day 15	Clinical significance was determined by the investigator.
Primary	Number of Participants With Clinically Significant Physical Examination Findings	From signing of informed consent up to Day 15	Clinical significance was determined by the investigator.
Primary	Number of Participants With Clinically Significant Vital Sign Findings	From signing of informed consent up to Day 15	Clinical significance was determined by the investigator.
Secondary	Number of Participants Free of Clinical Spasms	Day 15	Clinical spasms were determined by video-electroencephalography (VEEG) for at least 8 hours and up to 24 hours.
Secondary	Percentage of Participants Free of Clinical Spasms	Day 15	Clinical spasms were determined by VEEG for at least 8 hours and up to 24 hours.
Secondary	Number of Participants With Resolution of Hypsarrhythmia	Day 15	Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

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 Severe Treatment-emergent Adverse Events (TEAEs)	From signing of informed consent up to Day 15	Safety Analysis Set: all participants who received at least 1 dose of GWP42003-P	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Any Low or High Hematology Laboratory Parameter Value	Day 4 and Day 15	Safety Analysis Set. Only participants with evaluable data were analyzed.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value	Day 4 and Day 15	Safety Analysis Set. Only participants with evaluable data were analyzed.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participant With Any Clinically Relevant Urinalysis Parameter Value	Day 4 and Day 15	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Electrocardiogram Findings	From signing of informed consent up to Day 15	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Physical Examination Findings	From signing of informed consent up to Day 15	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Vital Sign Findings	From signing of informed consent up to Day 15	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Free of Clinical Spasms	Day 15	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants Free of Clinical Spasms	Day 15	Safety Analysis Set	percentage of participants	NUMBER
SECONDARY	Number of Participants With Resolution of Hypsarrhythmia	Day 15	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group52

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

Outcome	Group	Category	Value	Units
Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs)	GWP42003-P OS		6	Participants
Number of Participants With Any Low or High Hematology Laboratory Parameter Value	GWP42003-P OS	Day 4, Low	4	Participants
Number of Participants With Any Low or High Hematology Laboratory Parameter Value	GWP42003-P OS	Day 4, High	4	Participants
Number of Participants With Any Low or High Hematology Laboratory Parameter Value	GWP42003-P OS	Day 15, Low	1	Participants
Number of Participants With Any Low or High Hematology Laboratory Parameter Value	GWP42003-P OS	Day 15, High	3	Participants
Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value	GWP42003-P OS	Day 4, Low	7	Participants
Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value	GWP42003-P OS	Day 4, High	5	Participants
Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value	GWP42003-P OS	Day 15, Low	5	Participants
Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value	GWP42003-P OS	Day 15, High	7	Participants
Number of Participant With Any Clinically Relevant Urinalysis Parameter Value	GWP42003-P OS	Day 4	0	Participants

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort 1: GWP42003-P OS	5
Overall Study	STARTED	Cohort 2: GWP42003-P OS	4
Overall Study	COMPLETED	Cohort 1: GWP42003-P OS	5
Overall Study	COMPLETED	Cohort 2: GWP42003-P OS	4
Overall Study	NOT COMPLETED	Cohort 1: GWP42003-P OS	0
Overall Study	NOT COMPLETED	Cohort 2: GWP42003-P OS	0

Source ClinicalTrials.gov

Adverse events11

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	Application site erosion	General disorders	GWP42003-P OS	1	9
other	Irritability	Psychiatric disorders	GWP42003-P OS	1	9
other	Cough	Respiratory, thoracic and mediastinal disorders	GWP42003-P OS	1	9
other	Somnolence	Nervous system disorders	GWP42003-P OS	1	9
other	Diarrhoea	Gastrointestinal disorders	GWP42003-P OS	2	9
other	Constipation	Gastrointestinal disorders	GWP42003-P OS	1	9
other	Vomiting	Gastrointestinal disorders	GWP42003-P OS	1	9
other	Haematuria	Renal and urinary disorders	GWP42003-P OS	1	9
other	Increased appetite	Metabolism and nutrition disorders	GWP42003-P OS	1	9
other	Upper respiratory tract infection	Infections and infestations	GWP42003-P OS	2	9

1 to 10 of 11Source ClinicalTrials.gov

See all 11 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GWP42003-P OS	0	9
Total, other adverse events	GWP42003-P OS	5	9
Total, serious adverse events	GWP42003-P OS	1	9

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT02953548

GET https://conductscience.org/api/trials/v1/NCT02953548/results?page=2

API reference For AI assistants