NCT02954887 is a Phase 3 clinical trial of GWP42003-P in Infantile Spasms, sponsored by Jazz Pharmaceuticals.

Who is sponsoring NCT02954887?

NCT02954887 is sponsored by Jazz Pharmaceuticals.

What drugs are being tested in NCT02954887?

Interventions in NCT02954887: GWP42003-P.

What condition does NCT02954887 study?

NCT02954887 studies Infantile Spasms.

Is NCT02954887 still recruiting?

NCT02954887 is currently completed. Last updated 2 September 2022.

Are results published for NCT02954887?

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

NCT02954887

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

Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (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 13 June 2019.

Timeline

12 May 2017

Primary endpoint
13 June 2019

13 June 2019

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	12 May 2017
Primary completion	13 June 2019
Estimated completion	13 June 2019
Sites	7 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 417

TEAEs were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. 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	7

Number of Participants With Any Low or High Hematology Laboratory Parameter Value Primary · Days 19, 29, 43, 71, 127, 211, 295, 379, and 389

Day 19, Low

Group	Value	95% CI
GWP42003-P OS	3

Day 19, High

Group	Value	95% CI
GWP42003-P OS	4

Day 29, Low

Group	Value	95% CI
GWP42003-P OS	3

Day 29, High

Group	Value	95% CI
GWP42003-P OS	4

Day 43, Low

Group	Value	95% CI
GWP42003-P OS	1

Day 43, High

Group	Value	95% CI
GWP42003-P OS	2

Day 71, Low

Group	Value	95% CI
GWP42003-P OS	1

Day 71, High

Group	Value	95% CI
GWP42003-P OS	3

Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value Primary · Days 19, 29, 43, 71, 127, 211, 295, 379, and 389

Day 19, Low

Group	Value	95% CI
GWP42003-P OS	6

Day 19, High

Group	Value	95% CI
GWP42003-P OS	7

Day 29, Low

Group	Value	95% CI
GWP42003-P OS	6

Day 29, High

Group	Value	95% CI
GWP42003-P OS	6

Day 43, Low

Group	Value	95% CI
GWP42003-P OS	4

Day 43, High

Group	Value	95% CI
GWP42003-P OS	5

Day 71, Low

Group	Value	95% CI
GWP42003-P OS	2

Day 71, High

Group	Value	95% CI
GWP42003-P OS	4

Number of Participants With Any Clinically Relevant Urinalysis Parameter Value Primary · Days 19, 29, 43, 71, 127, 211, 295, 379, and 389

Clinical relevance was determined by the investigator.

Day 19

Group	Value	95% CI
GWP42003-P OS	0

Day 29

Group	Value	95% CI
GWP42003-P OS	0

Day 43

Group	Value	95% CI
GWP42003-P OS	0

Day 71

Group	Value	95% CI
GWP42003-P OS	1

Day 127

Group	Value	95% CI
GWP42003-P OS	0

Day 211

Group	Value	95% CI
GWP42003-P OS	0

Day 295

Group	Value	95% CI
GWP42003-P OS	0

Day 379

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 389

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 389

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 389

Clinical significance was determined by the investigator.

Group	Value	95% CI
GWP42003-P OS	0

Number of Participants Free of Clinical Spasms Secondary · Days 29, 43, 127, 211, 295, and 379

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

Day 29

Group	Value	95% CI
GWP42003-P OS	1

Day 43

Group	Value	95% CI
GWP42003-P OS	2

Day 127

Group	Value	95% CI
GWP42003-P OS	1

Day 211

Group	Value	95% CI
GWP42003-P OS	1

Day 295

Group	Value	95% CI
GWP42003-P OS	1

Day 379

Group	Value	95% CI
GWP42003-P OS	3

Percentage of Participants Free of Clinical Spasms Secondary · Days 29, 43, 127, 211, 295, and 379

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

Day 29

Group	Value	95% CI
GWP42003-P OS	11.1

Day 43

Group	Value	95% CI
GWP42003-P OS	22.2

Day 127

Group	Value	95% CI
GWP42003-P OS	11.1

Day 211

Group	Value	95% CI
GWP42003-P OS	11.1

Day 295

Group	Value	95% CI
GWP42003-P OS	11.1

Day 379

Group	Value	95% CI
GWP42003-P OS	33.3

Number of Participants With a Resolution of Hypsarrhythmia Secondary · Days 29, 43, 127, 211, 295, and 379

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

Day 29

Group	Value	95% CI
GWP42003-P OS	1

Day 43

Group	Value	95% CI
GWP42003-P OS	0

Day 127

Group	Value	95% CI
GWP42003-P OS	1

Day 211

Group	Value	95% CI
GWP42003-P OS	0

Day 295

Group	Value	95% CI
GWP42003-P OS	1

Day 379

Group	Value	95% CI
GWP42003-P OS	3

Percentage of Participants With a Resolution of Hypsarrhythmia Secondary · Days 29, 43, 127, 211, 295, and 379

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

Day 29

Group	Value	95% CI
GWP42003-P OS	11.1

Day 43

Group	Value	95% CI
GWP42003-P OS	0

Day 127

Group	Value	95% CI
GWP42003-P OS	11.1

Day 211

Group	Value	95% CI
GWP42003-P OS	0

Day 295

Group	Value	95% CI
GWP42003-P OS	11.1

Day 379

Group	Value	95% CI
GWP42003-P OS	33.3

Number of Participants Experiencing Spasms and Seizures by Subtype Secondary · Days 19, 29, 127, 211, 295, and 379

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

Day 19, Clonic

Group	Value	95% CI
GWP42003-P OS	0

Day 19, Tonic-Clonic

Group	Value	95% CI
GWP42003-P OS	0

Day 19, Atonic

Group	Value	95% CI
GWP42003-P OS	0

Day 19, Myoclonic

Group	Value	95% CI
GWP42003-P OS	0

Day 19, Focal

Group	Value	95% CI
GWP42003-P OS	1

Day 19, Absence

Group	Value	95% CI
GWP42003-P OS	0

Day 19, Not Done

Group	Value	95% CI
GWP42003-P OS	0

Day 29, 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 417. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cannabidiol OS

Serious: 2/9 (22%)

Deaths: 0/9

Serious adverse events (15 terms)

Reaction	System	Cannabidiol OS
Enterovirus infection	Infections and infestations	—
Pneumonia	Infections and infestations	—
Rhinovirus infection	Infections and infestations	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—
Respiratory distress	Respiratory, thoracic and mediastinal disorders	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Urinary retention	Renal and urinary disorders	—
Bronchiolitis	Infections and infestations	—
Pneumonia bacterial	Infections and infestations	—
Pneumonia klebsiella	Infections and infestations	—
Urinary tract infection bacterial	Infections and infestations	—
Viral upper respiratory infection	Infections and infestations	—

Other adverse events (35 terms — click to expand)

Reaction	System	Cannabidiol OS
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	—
Pyrexia	General disorders	—
Irritability	Psychiatric disorders	—
Blood triglycerides increased	Investigations	—
Anaemia	Blood and lymphatic system disorders	—
Urinary tract infection	Infections and infestations	—
Hypertension	Vascular disorders	—
Hypotension	Vascular disorders	—
Drug tolerance	General disorders	—
Sleep disorder	Psychiatric disorders	—
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	—
Somnolence	Nervous system disorders	—
Myoclonic epilepsy	Nervous system disorders	—
Petit mal epilepsy	Nervous system disorders	—
Pupils unequal	Eye disorders	—
Deafness	Ear and labyrinth disorders	—
Middle ear effusion	Ear and labyrinth disorders	—
Gingival pain	Gastrointestinal disorders	—
Dermatitis diaper	Skin and subcutaneous tissue disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Skin irritation	Skin and subcutaneous tissue disorders	—
Scoliosis	Musculoskeletal and connective tissue disorders	—
Decreased appetite	Metabolism and nutrition disorders	—
Feeding intolerance	Metabolism and nutrition disorders	—
Fluid overload	Metabolism and nutrition disorders	—
Hypokalaemia	Metabolism and nutrition disorders	—
Hyponatraemia	Metabolism and nutrition disorders	—
Viral infection	Infections and infestations	—
Bronchiolitis	Infections and infestations	—
Ear infection	Infections and infestations	—
Nasopharyngitis	Infections and infestations	—
Otitis media	Infections and infestations	—
Pneumonia	Infections and infestations	—
Sinusitis	Infections and infestations	—
Viral upper respiratory tract infection	Infections and infestations	—

Most-reported serious reactions: Enterovirus infection, Pneumonia, Rhinovirus infection, Acute respiratory failure, Hypoxia, Pneumonia aspiration, Respiratory distress, Respiratory failure.

Data from ClinicalTrials.gov NCT02954887 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 open-label extension phase only will be described in this record. All participants will receive GWP42003-P.

Publications & conference data

3 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
Parent-reported outcome measures evaluating communication in individuals with rare neurodevelopmental disorders: A systematic review.
Saldaris JM, Ayalde J, Kankanange S, Keeley J, et al · · 2024 · cited 2× · PMID 39141588 · DOI 10.1111/1460-6984.13100

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 NCT02954887 (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/NCT02954887.

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

NCT02954887

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 (15 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