Trial · NCT04485104
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
NCT04485104, Phase 3, Terminated, Jazz Pharmaceuticals; results first posted 2025-10-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures. Trials, record NCT04485104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04485104
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
- NCT number
- NCT04485104
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Interventions
- GWP42003-P
- First posted
- 2020-07-24
- Last updated
- 2025-10-31
- Other registries' IDs
- eudract:2020-002132-67
- Results first posted
- 2025-10-31
- Limitations and caveats
Three participants were enrolled. There was not enough information to answer the research questions. The limited data collected were not enough to provide meaningful conclusions regarding the efficacy, safety, and PK of CBD-OS in this clinical trial.
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 Treatment-Emergent Adverse Events (TEAEs) | From start of treatment to the post-treatment safety follow-up visit, up to 62 weeks | |
| Primary | Mean Change From Baseline in Blood Pressure | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in Pulse Rate | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in Respiratory Rate | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in Body Temperature | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in Height | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in Body Weight | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in Heart Rate | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in RR Interval | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in PR Interval | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks |
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 Treatment-Emergent Adverse Events (TEAEs) | From start of treatment to the post-treatment safety follow-up visit, up to 62 weeks | Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set. | participants | NUMBER |
| PRIMARY | Mean Change From Baseline in Blood Pressure | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Blood pressure was assessed in the Safety Analysis Set. | mmHg | MEAN |
| PRIMARY | Mean Change From Baseline in Pulse Rate | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Pulse rate was assessed in the Safety Analysis Set. | beats per minute | MEAN |
| PRIMARY | Mean Change From Baseline in Respiratory Rate | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Respiratory rate was assessed in the Safety Analysis Set. | breaths/minute | MEAN |
| PRIMARY | Mean Change From Baseline in Body Temperature | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Body temperature was assessed in the Safety Analysis Set. | degrees Celsius | MEAN |
| PRIMARY | Mean Change From Baseline in Height | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Height was assessed in the Safety Analysis Set. | centimeters | MEAN |
| PRIMARY | Mean Change From Baseline in Body Weight | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Body weight was assessed in the Safety Analysis Set. | kilogram | MEAN |
| PRIMARY | Mean Change From Baseline in Heart Rate | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Heart rate was assessed in participants with available data in the Safety Analysis Set. | beats/minute | MEAN |
| PRIMARY | Mean Change From Baseline in RR Interval | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | RR interval was assessed in participants with available data in the Safety Analysis Set. | millisecond | MEAN |
| PRIMARY | Mean Change From Baseline in PR Interval | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | PR interval was assessed in the Safety Analysis Set. | millisecond | MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group226
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 Treatment-Emergent Adverse Events (TEAEs) | Tuberous Sclerosis Complex | 2 | participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Dravet Syndrome | 1 | participants | ||
| Mean Change From Baseline in Blood Pressure | Tuberous Sclerosis Complex | Systolic blood pressure | -3.0 | Standard Deviation 9.90 | mmHg |
| Mean Change From Baseline in Blood Pressure | Dravet Syndrome | Systolic blood pressure | 11.0 | Standard Deviation NA | mmHg |
| Mean Change From Baseline in Blood Pressure | Tuberous Sclerosis Complex | Diastolic blood pressure | 13.5 | Standard Deviation 19.09 | mmHg |
| Mean Change From Baseline in Blood Pressure | Dravet Syndrome | Diastolic blood pressure | -2.0 | Standard Deviation NA | mmHg |
| Mean Change From Baseline in Pulse Rate | Tuberous Sclerosis Complex | -11.0 | Standard Deviation 1.41 | beats per minute | |
| Mean Change From Baseline in Pulse Rate | Dravet Syndrome | 11.0 | Standard Deviation NA | beats per minute | |
| Mean Change From Baseline in Respiratory Rate | Tuberous Sclerosis Complex | -10.0 | Standard Deviation 16.97 | breaths/minute | |
| Mean Change From Baseline in Respiratory Rate | Dravet Syndrome | 0 | Standard Deviation NA | breaths/minute |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tuberous Sclerosis Complex | 2 | |
| Overall Study | STARTED | Dravet Syndrome | 1 | |
| Overall Study | COMPLETED | Tuberous Sclerosis Complex | 0 | |
| Overall Study | COMPLETED | Dravet Syndrome | 0 | |
| Overall Study | NOT COMPLETED | Tuberous Sclerosis Complex | 2 | |
| Overall Study | NOT COMPLETED | Dravet Syndrome | 1 |
Source ClinicalTrials.gov
Adverse events36
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 | Teething | Gastrointestinal disorders | Tuberous Sclerosis Complex | 1 | 2 | 1 |
| other | Teething | Gastrointestinal disorders | Dravet Syndrome | 0 | 1 | 0 |
| other | Fatigue | General disorders | Tuberous Sclerosis Complex | 0 | 2 | 0 |
| other | Fatigue | General disorders | Dravet Syndrome | 1 | 1 | 1 |
| other | Bronchitis | Infections and infestations | Tuberous Sclerosis Complex | 1 | 2 | 1 |
| other | Bronchitis | Infections and infestations | Dravet Syndrome | 0 | 1 | 0 |
| other | Ear infection | Infections and infestations | Tuberous Sclerosis Complex | 1 | 2 | 1 |
| other | Ear infection | Infections and infestations | Dravet Syndrome | 0 | 1 | 0 |
| other | Pneumonia | Infections and infestations | Tuberous Sclerosis Complex | 1 | 2 | 3 |
| other | Pneumonia | Infections and infestations | Dravet Syndrome | 0 | 1 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tuberous Sclerosis Complex | 0 | 2 |
| Total, all-cause mortality | Dravet Syndrome | 0 | 1 |
| Total, other adverse events | Tuberous Sclerosis Complex | 1 | 2 |
| Total, other adverse events | Dravet Syndrome | 1 | 1 |
| Total, serious adverse events | Tuberous Sclerosis Complex | 2 | 2 |
| Total, serious adverse events | Dravet Syndrome | 0 | 1 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tuberous Sclerosis Complex vs Dravet Syndrome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| Tuberous Sclerosis Complex vs Dravet Syndrome: deaths from any cause | Trial comparisons |
| Tuberous Sclerosis Complex vs Dravet Syndrome: Number of Participants With Emergence of New Types of Seizures | Trial comparisons |
| Tuberous Sclerosis Complex vs Dravet Syndrome: serious adverse events | Trial comparisons |
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/NCT04485104
GET https://conductscience.org/api/trials/v1/NCT04485104/registered?page=2