NCT02953548 is a Phase 3 clinical trial of GWP42003-P in Infantile Spasms, sponsored by Jazz Pharmaceuticals.

Who is sponsoring NCT02953548?

NCT02953548 is sponsored by Jazz Pharmaceuticals.

What drugs are being tested in NCT02953548?

Interventions in NCT02953548: GWP42003-P.

What condition does NCT02953548 study?

NCT02953548 studies Infantile Spasms.

Is NCT02953548 still recruiting?

NCT02953548 is currently completed. Last updated 2 September 2022.

Are results published for NCT02953548?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-09-02 · How we verify

NCT02953548

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 2 September 2022

What this trial tests

Phase 3 trial testing GWP42003-P in Infantile Spasms in 9 participants. Completed in 7 May 2018.

Timeline

24 April 2017

Primary endpoint
7 May 2018

7 May 2018

Quick facts

Lead sponsor	Jazz Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	24 April 2017
Primary completion	7 May 2018
Estimated completion	7 May 2018
Sites	8 locations across United States, Poland

Drugs / interventions tested

GWP42003-P — full drug profile →

Conditions studied

Infantile Spasms — all drugs for Infantile Spasms →

Sponsor

Jazz Pharmaceuticals — full company profile →

Who can join

Adults 1 Month to 24 Months, any sex, with Infantile Spasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) Primary · 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.

Group	Value	95% CI
GWP42003-P OS	6

Number of Participants With Any Low or High Hematology Laboratory Parameter Value Primary · Day 4 and Day 15

Day 4, Low

Group	Value	95% CI
GWP42003-P OS	4

Day 4, High

Group	Value	95% CI
GWP42003-P OS	4

Day 15, Low

Group	Value	95% CI
GWP42003-P OS	1

Day 15, High

Group	Value	95% CI
GWP42003-P OS	3

Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value Primary · Day 4 and Day 15

Day 4, Low

Group	Value	95% CI
GWP42003-P OS	7

Day 4, High

Group	Value	95% CI
GWP42003-P OS	5

Day 15, Low

Group	Value	95% CI
GWP42003-P OS	5

Day 15, High

Group	Value	95% CI
GWP42003-P OS	7

Number of Participant With Any Clinically Relevant Urinalysis Parameter Value Primary · Day 4 and Day 15

Clinical relevance was determined by the investigator.

Day 4

Group	Value	95% CI
GWP42003-P OS	0

Day 15

Group	Value	95% CI
GWP42003-P OS	0

Number of Participants With Clinically Significant Electrocardiogram Findings Primary · From signing of informed consent up to Day 15

Clinical significance was determined by the investigator.

Group	Value	95% CI
GWP42003-P OS	0

Number of Participants With Clinically Significant Physical Examination Findings Primary · From signing of informed consent up to Day 15

Clinical significance was determined by the investigator.

Group	Value	95% CI
GWP42003-P OS	0

Number of Participants With Clinically Significant Vital Sign Findings Primary · From signing of informed consent up to Day 15

Clinical significance was determined by the investigator.

Group	Value	95% CI
GWP42003-P OS	0

Number of Participants Free of Clinical Spasms Secondary · Day 15

Clinical spasms were determined by video-electroencephalography (VEEG) for at least 8 hours and up to 24 hours.

Group	Value	95% CI
GWP42003-P OS	0

Percentage of Participants Free of Clinical Spasms Secondary · Day 15

Clinical spasms were determined by VEEG for at least 8 hours and up to 24 hours.

Group	Value	95% CI
GWP42003-P OS	0

Number of Participants With Resolution of Hypsarrhythmia Secondary · Day 15

Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours.

Group	Value	95% CI
GWP42003-P OS	0

Percentage of Participants With Resolution of Hypsarrhythmia Secondary · Day 15

Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours.

Group	Value	95% CI
GWP42003-P OS	0

Number of Participants Experiencing Spasms and Seizures by Subtype Secondary · Day 4 and Day 15

Caregivers recorded the participant's spasms and seizures by category in a daily diary. Subtypes of spasms and seizures included: clonic, tonic-clonic, myoclonic, focal, and absence.

Day 4, Clonic

Group	Value	95% CI
GWP42003-P OS	0

Day 4, Tonic-Clonic

Group	Value	95% CI
GWP42003-P OS	1

Day 4, Atonic

Group	Value	95% CI
GWP42003-P OS	0

Day 4, Myoclonic

Group	Value	95% CI
GWP42003-P OS	0

Day 4, Focal

Group	Value	95% CI
GWP42003-P OS	1

Day 4, Absence

Group	Value	95% CI
GWP42003-P OS	0

Day 4, Not Done

Group	Value	95% CI
GWP42003-P OS	0

Day 15, Clonic

Group	Value	95% CI
GWP42003-P OS	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From signing of informed consent up to Day 15. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GWP42003-P OS

Serious: 1/9 (11%)

Deaths: 0/9

Serious adverse events (1 terms)

Reaction	System	GWP42003-P OS
Status epilepticus	Nervous system disorders	—

Other adverse events (10 terms — click to expand)

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

Most-reported serious reactions: Status epilepticus.

Data from ClinicalTrials.gov NCT02953548 adverse events section.

Sponsor's own description

This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The pilot phase only will be described in this record. 2 cohorts of 5 participants will be enrolled sequentially. All participants will receive GWP42003-P.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Use of Cannabidiol in the Treatment of Epilepsy: Efficacy and Security in Clinical Trials.
Silvestro S, Mammana S, Cavalli E, Bramanti P, et al · · 2019 · cited 114× · PMID 31013866 · DOI 10.3390/molecules24081459
Medical Cannabis in Pediatric Oncology: Friend or Foe?
Malach M, Kovalchuk I, Kovalchuk O. · · 2022 · cited 8× · PMID 35337156 · DOI 10.3390/ph15030359

Verify or expand the search:

Other trials of GWP42003-P

Trials testing the same drug.

NCT05288283 — Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures · Phase 3 · terminated
NCT04745026 — Trial to Investigate the Safety and Efficacy of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) in Children and Adolescen · Phase 2 · completed
NCT04485104 — Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Drave · Phase 3 · terminated
NCT04421456 — Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants With Sch · Phase 2 · terminated
NCT04252586 — A Long-term Safety Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome · Phase 3 · terminated

Other recruiting trials for Infantile Spasms

Currently open trials in the same condition.

NCT06819670 — A Study to Prevent Infantile Spasms Relapse · Phase 2 · recruiting

Other Jazz Pharmaceuticals trials

Trials by the same sponsor.

NCT07533942 — A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma · Phase 2 · not yet recruiting
NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC · Phase 2 · not yet recruiting
NCT07377539 — A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants · Phase 1 · not yet recruiting
NCT07282587 — Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma · Phase 2 · recruiting
NCT07233239 — A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02953548 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jazz Pharmaceuticals
Last refreshed: 2 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02953548.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02953548

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of GWP42003-P

Other recruiting trials for Infantile Spasms

Other Jazz Pharmaceuticals trials

Verify against primary sources