Seizure in Participants With Tuberous Sclerosis ComplexPhase 3NCT04485104
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
A Phase 3 study testing GWP42003-P in people with Seizure in Participants With Tuberous Sclerosis Complex and Seizure in Participants With Dravet Syndrome, run by Jazz Pharmaceuticals at 11 sites in 3 countries.
Trial summary
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet syndrome (DS). Read more about this study
- Who is it for?
- Ages 1 month to 23 months
- Conditions the study is for
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- What is being tested?
- GWP42003-P
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 19 May 2021to 28 Jan 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants with TSC (1 month to < 2 years of age), or DS (1 year to < 2 years of age), or LGS (1 year to < 2 years of age) within the specified age range at the time of initial informed consent.
- Parent(s)/legal representative is/are willing and able to give informed consent for participation in the study.
- Parent(s)/legal representative is/are willing and able (in the investigator's opinion) to comply with all study requirements (including accurate electronic participant-reported outcome [ePRO] diary completion).
- Participants with TSC must have a diagnosis per the 2012 International Tuberous Sclerosis Complex Consensus Conference. Participants with LGS or DS must have a diagnosis that is consistent with International League Against Epilepsy (ILAE) guidelines and confirmed by the Epilepsy Study Consortium (ESCI).
- Participants who have uncontrolled seizures, and who are currently receiving 1 or more antiseizure medication (ASMs).
- A suitable VEEG, as available in the medical record, within 1 year of Visit 1. When a historical VEEG is not available, and if clinically indicated and appropriate (due to uncertainties or new seizures), a VEEG will be completed and read to confirm diagnosis prior to Visit 3. All VEEGs are to be read at baseline by the investigator and by an independent reviewer.
- Has seizures which are not adequately controlled through their current ASMs, defined as ≥ 1 seizure reported on the seizure diary during the screening/baseline period
Who cannot join
- Has tumor growth which, in the opinion of the investigator, could affect participant safety.
- Has clinically significant abnormal laboratory values, in the investigator's opinion, at screening/baseline.
- Has clinically significant abnormalities in the electrocardiogram (ECG) measured at screening/baseline.
- Has any concurrent cardiovascular conditions, that will, in the investigator's opinion, interfere with the ability to assess their ECGs.
- Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention such as sesame seed oil.
- Has significantly impaired hepatic function prior to Visit 3, defined as:
Show all 16Show fewer
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN) and (total bilirubin [TBL] > 2 × ULN or international normalized ratio [INR] > 1.5).
- Serum ALT or AST > 5 × ULN.
- Serum ALT or AST > 3 × ULN with the presence of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (> 5%).
- Elevated ALT or AST should be discussed with the medical monitor prior to Visit 3; the medical monitor may allow for a confirmatory re-draw prior to Visit 3.
- Has received another study intervention within 4 weeks prior to Visit 1 or plans to take another study intervention during the study.
- Has any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant, other participants, or site staff at risk because of participation in the study, may influence the result of the study, or may affect the participant's ability to take part in the study.
- Any clinically significant abnormalities identified following a physical examination of the participant that, in the opinion of the investigator, would jeopardize the safety of the participant if they took part in the study.
- Has previously been enrolled into this study.
- Has plans to travel outside their country of residence during the study, unless the participant has confirmation that the study intervention is permitted in the destination country.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States6 sites
Clinical Trial Site
Boston, Massachusetts, 02114
Clinical Trial Site
Chicago, Illinois, 60611
Clinical Trial Site
Cincinnati, Ohio, 45229
Clinical Trial Site
Houston, Texas, 77030
Clinical Trial Site
Little Rock, Arkansas, 72202
Clinical Trial Site
Los Angeles, California, 90095
Italy3 sites
Clinical Trial Site
Florence, 50139
Clinical Trial Site
Genova, 16147
Clinical Trial Site
Rome, 00165
Spain2 sites
Clinical Trial Site
Barcelona, 08950
Clinical Trial Site
Madrid, 28034
About this study
Official title: An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet syndrome (DS).
Read the detailed description
The study duration will be up to approximately 62 weeks, including a 4-week screening/baseline period, a 52-week dose optimization treatment period (which includes a fixed 2-week titration period followed by flexible dose optimization), a 10-day taper period, and a safety follow-up period (4 weeks after the end-of-taper visit).
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Being tested
- GWP42003-P
- Keywords
- Epilepsy, Seizures, Infantile Spasms, Pediatric, Children, Infants, Cannabidiol oral solution, GWP42003-P, Tuberous Sclerosis Complex, TSC, Tuberous Sclerosis, Cannabidiol, Epidiolex, CBD, Seizure, Child, TSC1, TSC2, Tuberous Sclerosis 1, Tuberous Sclerosis 2
- Medical subject headings
- Epilepsy, Seizures, Spasms, Infantile, Tuberous Sclerosis, Tuberous Sclerosis 1, Tuberous Sclerosis 2, Lennox Gastaut Syndrome, Epilepsies, Myoclonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GWP42003-PDrug
Also called Cannabidiol, Epidiolex, Epidyolex
Oral Solution
| Study group | Role | What they receive |
|---|---|---|
| GWP42003-P | Experimental | The 52-week treatment period includes a fixed 2-week titration schedule followed by flexible dose optimization.
Day 1: 5 mg/kg/day (2.5 mg/kg twice daily (b.i.d.))
Day 8: 10 mg/kg/day (5 mg/kg b.i.d.)
Day 15 to Week 52: Flexible dosing based on the participant's observed efficacy, safety, and tolerability per the investigator's clinical judgement. Up to a maximum of 20 mg/kg/day (10 mg/kg b.i.d.) for LGS and DS or 25 mg/kg/day (12.5 mg/kg b.i.d.) for TSC, in maximum weekly increments of 5 mg/kg/day (≤ 2.5 mg/kg b.i.d.). Receives: Drug: GWP42003-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: From start of treatment to the post-treatment safety follow-up visit, up to 62 weeks
Mean Change From Baseline in Blood Pressure
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in Pulse Rate
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in Respiratory Rate
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in Body Temperature
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in Height
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in Body Weight
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in Heart Rate
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in RR Interval
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in PR Interval
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in QRS Duration
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in QT Interval
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in QTcB and QTcF
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Number of Participants With a Clinically Significant Change in Laboratory Parameters
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Number of Participants With Emergence of New Types of Seizures
Measured: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Plasma Concentrations of GWP42003-P and Its Major Metabolites
Measured: Predose, 3 hours and 6 hours post dose at End of Treatment (Week 52)
Number of Participants Based on Percentage Change From Baseline in Indication-Specific Total Countable Seizures as Recorded by Caregivers
Measured: Day 1 up to Taper Period, up to Week 52
Clinician Global Impression of Severity (CGI/S) Score
The CGIC/S is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores are reported.
The severity of impairment in each domain is rated by the clinician in a scale of 1 through 7 where 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Higher scores indicate poor clinical outcome.
Measured: At Day 365 (EOT)
Clinician Global Impression of Change (CGI/C) Score
The CGI/C is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores are reported.
The severity of impairment in each domain is rated by the clinician in a scale of 1 through 7 where 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Higher scores indicate poor clinical outcome.
Measured: At Day 365 (EOT)
Secondary outcomes (3)
Number of Treatment Responders
Treatment Responders are defined as participants with ≥ 50% reduction from baseline in caregiver-reported total countable seizures
Measured: Day 1 up to the taper period, up to Week 52
Number of Participants Who Achieved Seizure-Free Status
Measured: Week 12, and every 4 weeks thereafter, up to date of withdrawal or Week 24, whichever occurs first
Percentage of Participants Still Receiving GWP42003-P
Measured: Week 12, and every 4 weeks thereafter, up to date of withdrawal or Week 24, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start19 May 2021
- Primary completion28 Jan 2025
- Study completion28 Jan 2025
Why it stopped: The study was terminated by the Sponsor due to low patient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seizure in Participants With Tuberous Sclerosis ComplexStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jazz Pharmaceuticals Research UK Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485104
- Sponsor's protocol ID
- GWEP17005
- Other IDs
- 2020-002132-67
- Status last verified
- Oct 2025
- First submitted
- 21 Jul 2020
- Last updated
- 31 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled Seizures
- ClinicalTrials.gov ID
- NCT04485104
- Acronym / sponsor ID
- GWEP17005
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Keywords
- Epilepsy, Seizures, Infantile Spasms, Pediatric, Children, Infants, Cannabidiol oral solution, GWP42003-P
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated by the Sponsor due to low patient enrollment.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Jazz Pharmaceuticals Research UK Limited
- Study start
- 19 May 2021 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Posted 31 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet syndrome (DS).
Detailed description
The study duration will be up to approximately 62 weeks, including a 4-week screening/baseline period, a 52-week dose optimization treatment period (which includes a fixed 2-week titration period followed by flexible dose optimization), a 10-day taper period, and a safety follow-up period (4 weeks after the end-of-taper visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GWP42003-P | Experimental | Drug: GWP42003-PThe 52-week treatment period includes a fixed 2-week titration schedule followed by flexible dose optimization. Day 1: 5 mg/kg/day (2.5 mg/kg twice daily (b.i.d.)) Day 8: 10 mg/kg/day (5 mg/kg b.i.d.) Day 15 to Week 52: Flexible dosing based on the participant's observed efficacy, safety, and tolerability per the investigator's clinical judgement. Up to a maximum of 20 mg/kg/day (10 mg/kg b.i.d.) for LGS and DS or 25 mg/kg/day (12.5 mg/kg b.i.d.) for TSC, in maximum weekly increments of 5 mg/kg/day (≤ 2.5 mg/kg b.i.d.). |
Who may qualify
- Ages
- 1 month to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Participants with TSC (1 month to < 2 years of age), or DS (1 year to < 2 years of age), or LGS (1 year to < 2 years of age) within the specified age range at the time of initial informed consent.
- Parent(s)/legal representative is/are willing and able to give informed consent for participation in the study.
- Parent(s)/legal representative is/are willing and able (in the investigator's opinion) to comply with all study requirements (including accurate electronic participant-reported outcome [ePRO] diary completion).
- Participants with TSC must have a diagnosis per the 2012 International Tuberous Sclerosis Complex Consensus Conference. Participants with LGS or DS must have a diagnosis that is consistent with International League Against Epilepsy (ILAE) guidelines and confirmed by the Epilepsy Study Consortium (ESCI).
- Participants who have uncontrolled seizures, and who are currently receiving 1 or more antiseizure medication (ASMs).
Key exclusion criteria (16 listed)
- Has tumor growth which, in the opinion of the investigator, could affect participant safety.
- Has clinically significant abnormal laboratory values, in the investigator's opinion, at screening/baseline.
- Has clinically significant abnormalities in the electrocardiogram (ECG) measured at screening/baseline.
- Has any concurrent cardiovascular conditions, that will, in the investigator's opinion, interfere with the ability to assess their ECGs.
- Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention such as sesame seed oil.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GWP42003-PAlso: Cannabidiol, Epidiolex, EpidyolexOral Solution | Drug | GWP42003-P |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From start of treatment to the post-treatment safety follow-up visit, up to 62 weeks
Mean Change From Baseline in Blood Pressure
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in Pulse Rate
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in Respiratory Rate
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in Body Temperature
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in Height
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in Body Weight
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in Heart Rate
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in RR Interval
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in PR Interval
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in QRS Duration
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in QT Interval
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Mean Change From Baseline in QTcB and QTcF
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Number of Participants With a Clinically Significant Change in Laboratory Parameters
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Number of Participants With Emergence of New Types of Seizures
Time frame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
Plasma Concentrations of GWP42003-P and Its Major Metabolites
Time frame: Predose, 3 hours and 6 hours post dose at End of Treatment (Week 52)
Number of Participants Based on Percentage Change From Baseline in Indication-Specific Total Countable Seizures as Recorded by Caregivers
Time frame: Day 1 up to Taper Period, up to Week 52
Clinician Global Impression of Severity (CGI/S) Score
Time frame: At Day 365 (EOT)
The CGIC/S is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores are reported. The severity of impairment in each domain is rated by the clinician in a scale of 1 through 7 where 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Higher scores indicate poor clinical outcome.
Clinician Global Impression of Change (CGI/C) Score
Time frame: At Day 365 (EOT)
The CGI/C is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores are reported. The severity of impairment in each domain is rated by the clinician in a scale of 1 through 7 where 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Higher scores indicate poor clinical outcome.
3 secondary outcomes
Number of Treatment Responders
Time frame: Day 1 up to the taper period, up to Week 52
Number of Participants Who Achieved Seizure-Free Status
Time frame: Week 12, and every 4 weeks thereafter, up to date of withdrawal or Week 24, whichever occurs first
Percentage of Participants Still Receiving GWP42003-P
Time frame: Week 12, and every 4 weeks thereafter, up to date of withdrawal or Week 24, whichever occurs first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GWP42003-P in people with Seizure in Participants With Tuberous Sclerosis Complex and Seizure in Participants With Dravet Syndrome, run by Jazz Pharmaceuticals at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From start of treatment to the post-treatment safety follow-up visit, up to 62 weeks). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.