Trial · NCT02954887
Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
NCT02954887, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2020-07-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7). Trials, record NCT02954887. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02954887
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
- NCT number
- NCT02954887
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 9 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Infantile Spasms
- Interventions
- GWP42003-P
- First posted
- 2016-11-04
- 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 outcomes24
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 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. |
| Primary | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | |
| Primary | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | |
| Primary | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | Clinical relevance was determined by the investigator. |
| Primary | Number of Participants With Clinically Significant Electrocardiogram Findings | From signing of informed consent up to Day 389 | 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 389 | 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 389 | Clinical significance was determined by the investigator. |
| Secondary | Number of Participants Free of Clinical Spasms | 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. |
| Secondary | Percentage of Participants Free of Clinical Spasms | Days 29, 43, 127, 211, 295, and 379 | Clinical spasms were determined by VEEG for at least 8 hours and up to 24 hours. |
| Secondary | Number of Participants With a Resolution of Hypsarrhythmia | 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. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
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 417 | Safety Analysis Set: all participants who had received ≥ 1 dose of GWP42003-P | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | 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 | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | Safety Analysis Set. Only participants with evaluable data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | Safety Analysis Set. Only participants with evaluable data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Electrocardiogram Findings | From signing of informed consent up to Day 389 | 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 389 | 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 389 | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Free of Clinical Spasms | Days 29, 43, 127, 211, 295, and 379 | Safety Analysis Set. Only participants with evaluable data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Free of Clinical Spasms | Days 29, 43, 127, 211, 295, and 379 | Safety Analysis Set. Only participants with evaluable data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With a Resolution of Hypsarrhythmia | Days 29, 43, 127, 211, 295, and 379 | Safety Analysis Set. Only participants with evaluable data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group269
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) | GWP42003-P OS | 7 | Participants | ||
| Number of Participants With Any Low or High Hematology Laboratory Parameter Value | GWP42003-P OS | Day 19, Low | 3 | Participants | |
| Number of Participants With Any Low or High Hematology Laboratory Parameter Value | GWP42003-P OS | Day 19, High | 4 | Participants | |
| Number of Participants With Any Low or High Hematology Laboratory Parameter Value | GWP42003-P OS | Day 29, Low | 3 | Participants | |
| Number of Participants With Any Low or High Hematology Laboratory Parameter Value | GWP42003-P OS | Day 29, High | 4 | Participants | |
| Number of Participants With Any Low or High Hematology Laboratory Parameter Value | GWP42003-P OS | Day 43, Low | 1 | Participants | |
| Number of Participants With Any Low or High Hematology Laboratory Parameter Value | GWP42003-P OS | Day 43, High | 2 | Participants | |
| Number of Participants With Any Low or High Hematology Laboratory Parameter Value | GWP42003-P OS | Day 71, Low | 1 | Participants | |
| Number of Participants With Any Low or High Hematology Laboratory Parameter Value | GWP42003-P OS | Day 71, High | 3 | Participants | |
| Number of Participants With Any Low or High Hematology Laboratory Parameter Value | GWP42003-P OS | Day 127, Low | 1 | Participants |
1 to 10 of 269Source ClinicalTrials.gov
See all 269 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GWP42003-P OS | 9 | |
| Overall Study | COMPLETED | GWP42003-P OS | 2 | |
| Overall Study | NOT COMPLETED | GWP42003-P OS | 7 |
Source ClinicalTrials.gov
Adverse events50
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 | Hypertension | Vascular disorders | Cannabidiol OS | 1 | 9 | |
| other | Hypotension | Vascular disorders | Cannabidiol OS | 1 | 9 | |
| other | Pyrexia | General disorders | Cannabidiol OS | 2 | 9 | |
| other | Drug tolerance | General disorders | Cannabidiol OS | 1 | 9 | |
| other | Irritability | Psychiatric disorders | Cannabidiol OS | 2 | 9 | |
| other | Sleep disorder | Psychiatric disorders | Cannabidiol OS | 1 | 9 | |
| other | Blood triglycerides increased | Investigations | Cannabidiol OS | 2 | 9 | |
| other | Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Cannabidiol OS | 3 | 9 | |
| other | Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | Cannabidiol OS | 1 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Cannabidiol OS | 2 | 9 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cannabidiol OS | 0 | 9 |
| Total, other adverse events | Cannabidiol OS | 7 | 9 |
| Total, serious adverse events | Cannabidiol OS | 2 | 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.
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/NCT02954887
GET https://conductscience.org/api/trials/v1/NCT02954887/registered?page=2