EpilepsyPhase 2NCT02607891
A Study of Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy
A Phase 2 study testing GWP42003-P in people with Epilepsy, run by Jazz Pharmaceuticals at 5 sites in 3 countries.
Trial summary
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will be randomized in a 4:1 ratio to receive GWP42003-P or matching placebo. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- GWP42003-P
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 9 Nov 2016to 2 Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant must be taking STP (for the STP arm) or VPA (for the VPA arm) and no more than 2 other antiepileptic drugs (AEDs) during the blinded period of the trial.
- In the VPA arm only, the participant must not be receiving STP (VPA allowed in STP arm).
- AED doses, including STP or VPA, must be stable for 4 weeks prior to screening and regimen must remain stable throughout the duration of the blinded period of the trial.
- Participant must have a documented magnetic resonance imaging/computerized tomography of the brain that ruled out a progressive neurologic condition.
- Participant must have experienced at least 1 countable uncontrolled seizure of any type (i.e., tonic-clonic, tonic, clonic, atonic, partial onset or focal: focal seizures with retained consciousness and a motor component, focal seizures with impaired consciousness, focal seizures evolving to bilateral secondary generalization) within 2 months prior to randomization.
- Intervention with vagus nerve stimulation and/or ketogenic diet must be stable for 4 weeks prior to baseline and the participant must be willing to maintain a stable regimen during the blinded period of the trial.
- Participant must abstain from alcohol during the blinded period of the trial.
Who cannot join
- Participant has clinically significant unstable medical conditions other than epilepsy.
- Participant has a history of symptoms related to a drop in blood pressure due to postural changes (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope).
- Participant has a QT interval, corrected for heart rate with Bazett's formula (QTcB), greater than:
- 450 msec for males.
- 470 msec for females.
- 480 msec if right bundle branch block is present.
Show all 20Show fewer
- Participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month or at screening.
- Participant has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or enrollment, other than epilepsy.
- Participant is currently using felbamate and has been taking it for less than 12 months prior to screening.
- Participant has consumed alcohol during the 7 days prior to enrollment and is unwilling to abstain during the blinded phase of the trail.
- Participant is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to trial entry.
- Participant has any known or suspected history of any drug abuse or addiction.
- Participant is unwilling to abstain from recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex) for the duration for the study.
- Participant has consumed grapefruit or grapefruit juice 7 days prior to enrollment and is unwilling to abstain from drinking grapefruit juice within 7 days of pharmacokinetic visits.
- Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP), e.g., sesame oil.
- Participant has received an IMP within the 12 weeks prior to the screening visit.
- Participant has significantly impaired hepatic function at the screening or randomization visit, defined as any of the following:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 × upper limit of normal (ULN).
- ALT or AST > 3 × ULN and total bilirubin (TBL) > 2 × ULN or international normalized ratio (INR) > 1.5.
- ALT or AST > 3 × ULN with the presence of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (> 5%).
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Ruber Internacional
Madrid
Hospital Universitario Virgen del Rocio
Seville
Netherlands1 site
SEIN - Epilepsy Institute in the Netherlands Foundation
Zwolle
About this study
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Pharmacokinetic Trial in 2 Parallel Groups to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and GWP42003-P in Patients With Epilepsy
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will be randomized in a 4:1 ratio to receive GWP42003-P or matching placebo. The hypothesis is that levels of stiripentol (STP) or valproate (VPA) may be altered (increased or decreased) as a result of using GWP42003-P.
- Conditions
- Epilepsy
- Being tested
- GWP42003-P, Placebo
- Keywords
- Cannabidiol, GWP42003-P, Epidiolex, Stiripentol, Valproate
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GWP42003-PDrug
Also called Cannabidiol, CBD, Epidiolex
Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
PlaceboDrug
Clear, colorless to yellow solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
| Study group | Role | What they receive |
|---|---|---|
| STP + GWP42003-P | Experimental | Administered orally, twice daily (morning and evening; immediately after the participant's STP dose), commencing with up-titration of 100 mg/mL GWP42003-P to a maintenance dose of 20 mg/kg/day over 11 days.
Participants remain on the maintenance dose for a further 14 days. Dosing is tapered (10% each day) for participants who do not enter the open-label-extension (OLE) phase or who withdraw early.
STP Arm: Last patient completion October 2018 Receives: Drug: GWP42003-P |
| STP + Placebo | Placebo comparator | Administered orally, twice daily (morning and evening; immediately after the participant's STP dose), commencing with up-titration of placebo to an equivalent maintenance dose of 20 mg/kg/day over 11 days.
Participants remain on the maintenance dose for a further 14 days. Dosing is tapered (10% each day) for participants who do not enter the OLE phase or who withdraw early.
STP Arm: Last patient completion February 2018 Receives: Drug: Placebo |
| VPA + GWP42003-P | Experimental | Administered orally, twice daily (morning and evening; immediately after the participant's VPA dose), commencing with up-titration of 100 mg/mL GWP42003-P to a maintenance dose of 20 mg/kg/day over 11 days.
Participants remain on the maintenance dose for a further 14 days. Dosing is tapered (10% each day) for participants who do not enter the OLE phase or who withdraw early.
VPA Arm: Last patient completion February 2018 Receives: Drug: GWP42003-P |
| VPA + Placebo | Placebo comparator | Administered orally, twice daily (morning and evening; immediately after the participant's VPA dose), commencing with up-titration of placebo to an equivalent maintenance dose of 20 mg/kg/day over 11 days.
Participants remain on the maintenance dose for a further 14 days. Dosing is tapered (10% each day) for participants who do not enter the OLE phase or who withdraw early.
VPA Arm: Last patient completion January 2018 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of STP, VPA, cannabidiol (CBD).
The Cmax of STP, VPA and CBD is presented.
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Time to the maximum plasma concentration (Tmax) of STP, VPA and CBD.
The Tmax of STP, VPA and CBD is presented.
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Area under the curve (AUC) from zero to final time of positive detection (0-t) of STP, VPA and CBD.
The AUC(0-t) of STP, VPA and CBD is presented.
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Area under the plasma concentration time curve over a dosing interval, where tau is the dosing interval [AUCtau].
The AUC(tau) of STP, VPA, and CBD is presented.
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Secondary outcomes (14)
Number of participants who experienced an adverse event.
The number of participants who experienced an adverse event during the trial is presented.
Measured: Up to 11 weeks.
Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG).
The number of participants with a clinically significant change in ECG is presented.
Measured: Up to 7 weeks.
Number of participants with a clinically significant change in serum biochemistry.
The number of participants with a clinically significant change in serum biochemistry is presented.
Measured: Up to 7 weeks.
Number of participants with a clinically significant change in hematology.
The number of participants with a clinically significant change in hematology is presented.
Measured: Up to 7 weeks.
Number of participants with a clinically significant change in urinalysis.
The number of participants with a clinically significant change in urinalysis is presented.
Measured: Up to 7 weeks.
Number of participants with a clinically significant change in vital signs.
The number of participants with a clinically significant change in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) is presented.
Measured: Up to 7 weeks.
Number of participants with a clinically significant change in physical examination.
The number of participants with a clinically significant change in physical examination is presented.
Measured: Up to 7 weeks.
Number of participants with a treatment-emergent suicidality flag.
Suicidality was assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). The number of participants with a treatment-emergent flag is presented.
Measured: Up to 7 weeks.
Seizure frequency by subtype.
The frequency of each subtype of seizure at baseline and end of treatment is presented.
Measured: Up to 6 weeks.
Number of participants with a treatment-emergent finding indicative of drug abuse liability.
Abuse liability was assessed through monitoring of triggering adverse events of interest and study medication accountability discrepancies. Any findings were assigned to an appropriate classification by the investigator. The number of participants with a treatment-emergent finding indicative of drug abuse liability is presented.
Measured: Up to 7 weeks.
Cmax of 4-ene-VPA, clobazam (CLB), N-desmethylclobazam (N-CLB), levetiracetam (LEV), and topiramate (TOP).
The Cmax of 4-ene-VPA, CLB, N-CLB, LEV, and TOP is presented.
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Tmax of 4-ene-VPA, CLB, N-CLB, LEV, and TOP.
The Tmax of 4-ene-VPA, CLB, N-CLB, LEV, and TOP is presented.
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
AUC(0-t) of 4-ene-VPA, CLB, N-CLB, LEV, and TOP.
The AUC(0-t) of 4-ene-VPA, CLB, N-CLB, LEV, and TOP is presented.
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
AUC(tau) of 4-ene-VPA, CLB, N-CLB, LEV, and TOP.
The AUC(tau) of 4-ene-VPA, CLB, N-CLB, LEV, and TOP is presented.
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start9 Nov 2016
- Primary completion11 Sep 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607891
- Sponsor's protocol ID
- GWEP1447 Blinded Phase
- Other IDs
- 2015-002939-18, 2015
- Status last verified
- Dec 2022
- First submitted
- 16 Nov 2015
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ben-Menachem E, Gunning B, Arenas Cabrera CM, VanLandingham K, Crockett J, Critchley D, Wray L, Tayo B, Morrison G, Toledo M. A Phase II Randomized Trial to Explore the Potential for Pharmacokinetic Drug-Drug Interactions with Stiripentol or Valproate when Combined with Cannabidiol in Patients with Epilepsy. CNS Drugs. 2020 Jun;34(6):661-672. doi: 10.1007/s40263-020-00726-4.
PubMed 32350749
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Randomized, Placebo-controlled Pharmacokinetic Trial in 2 Parallel Groups to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and GWP42003-P in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT02607891
- Acronym / sponsor ID
- GWEP1447 Blinded Phase
- Conditions
- Epilepsy
- Keywords
- Cannabidiol, GWP42003-P, Epidiolex, Stiripentol, Valproate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will be randomized in a 4:1 ratio to receive GWP42003-P or matching placebo. The hypothesis is that levels of stiripentol (STP) or valproate (VPA) may be altered (increased or decreased) as a result of using GWP42003-P.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| STP + GWP42003-P | Experimental | Drug: GWP42003-PAdministered orally, twice daily (morning and evening; immediately after the participant's STP dose), commencing with up-titration of 100 mg/mL GWP42003-P to a maintenance dose of 20 mg/kg/day over 11 days. Participants remain on the maintenance dose for a further 14 days. Dosing is tapered (10% each day) for participants who do not enter the open-label-extension (OLE) phase or who withdraw early. STP Arm: Last patient completion October 2018 |
| STP + Placebo | Placebo comparator | Drug: PlaceboAdministered orally, twice daily (morning and evening; immediately after the participant's STP dose), commencing with up-titration of placebo to an equivalent maintenance dose of 20 mg/kg/day over 11 days. Participants remain on the maintenance dose for a further 14 days. Dosing is tapered (10% each day) for participants who do not enter the OLE phase or who withdraw early. STP Arm: Last patient completion February 2018 |
| VPA + GWP42003-P | Experimental | Drug: GWP42003-PAdministered orally, twice daily (morning and evening; immediately after the participant's VPA dose), commencing with up-titration of 100 mg/mL GWP42003-P to a maintenance dose of 20 mg/kg/day over 11 days. Participants remain on the maintenance dose for a further 14 days. Dosing is tapered (10% each day) for participants who do not enter the OLE phase or who withdraw early. VPA Arm: Last patient completion February 2018 |
| VPA + Placebo | Placebo comparator | Drug: PlaceboAdministered orally, twice daily (morning and evening; immediately after the participant's VPA dose), commencing with up-titration of placebo to an equivalent maintenance dose of 20 mg/kg/day over 11 days. Participants remain on the maintenance dose for a further 14 days. Dosing is tapered (10% each day) for participants who do not enter the OLE phase or who withdraw early. VPA Arm: Last patient completion January 2018 |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Participant must be taking STP (for the STP arm) or VPA (for the VPA arm) and no more than 2 other antiepileptic drugs (AEDs) during the blinded period of the trial.
- AED doses, including STP or VPA, must be stable for 4 weeks prior to screening and regimen must remain stable throughout the duration of the blinded period of the trial.
- Participant must have a documented magnetic resonance imaging/computerized tomography of the brain that ruled out a progressive neurologic condition.
- Participant must have experienced at least 1 countable uncontrolled seizure of any type (i.e., tonic-clonic, tonic, clonic, atonic, partial onset or focal: focal seizures with retained consciousness and a motor component, focal seizures with impaired consciousness, focal seizures evolving to bilateral secondary generalization) within 2 months prior to randomization.
- Intervention with vagus nerve stimulation and/or ketogenic diet must be stable for 4 weeks prior to baseline and the participant must be willing to maintain a stable regimen during the blinded period of the trial.
Key exclusion criteria (20 listed)
- Participant has clinically significant unstable medical conditions other than epilepsy.
- Participant has a history of symptoms related to a drop in blood pressure due to postural changes (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope).
- Participant has a QT interval, corrected for heart rate with Bazett's formula (QTcB), greater than:
- Participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month or at screening.
- Participant has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or enrollment, other than epilepsy.
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, CBD, EpidiolexClear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. | Drug | STP + GWP42003-P, VPA + GWP42003-P |
| PlaceboClear, colorless to yellow solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. | Drug | STP + Placebo, VPA + Placebo |
Primary outcome
Maximum plasma concentration (Cmax) of STP, VPA, cannabidiol (CBD).
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
The Cmax of STP, VPA and CBD is presented.
Time to the maximum plasma concentration (Tmax) of STP, VPA and CBD.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
The Tmax of STP, VPA and CBD is presented.
Area under the curve (AUC) from zero to final time of positive detection (0-t) of STP, VPA and CBD.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
The AUC(0-t) of STP, VPA and CBD is presented.
Area under the plasma concentration time curve over a dosing interval, where tau is the dosing interval [AUCtau].
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
The AUC(tau) of STP, VPA, and CBD is presented.
14 secondary outcomes
Number of participants who experienced an adverse event.
Time frame: Up to 11 weeks.
Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG).
Time frame: Up to 7 weeks.
Number of participants with a clinically significant change in serum biochemistry.
Time frame: Up to 7 weeks.
Number of participants with a clinically significant change in hematology.
Time frame: Up to 7 weeks.
Number of participants with a clinically significant change in urinalysis.
Time frame: Up to 7 weeks.
Number of participants with a clinically significant change in vital signs.
Time frame: Up to 7 weeks.
Number of participants with a clinically significant change in physical examination.
Time frame: Up to 7 weeks.
Number of participants with a treatment-emergent suicidality flag.
Time frame: Up to 7 weeks.
Seizure frequency by subtype.
Time frame: Up to 6 weeks.
Number of participants with a treatment-emergent finding indicative of drug abuse liability.
Time frame: Up to 7 weeks.
Cmax of 4-ene-VPA, clobazam (CLB), N-desmethylclobazam (N-CLB), levetiracetam (LEV), and topiramate (TOP).
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Tmax of 4-ene-VPA, CLB, N-CLB, LEV, and TOP.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
AUC(0-t) of 4-ene-VPA, CLB, N-CLB, LEV, and TOP.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
AUC(tau) of 4-ene-VPA, CLB, N-CLB, LEV, and TOP.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Derived from this study: PubMed 32350749Ben-Menachem E, Gunning B, Arenas Cabrera CM, VanLandingham K, Crockett J, Critchley D, Wray L, Tayo B, Morrison G, Toledo M. A Phase II Randomized Trial to Explore the Potential for Pharmacokinetic Drug-Drug Interactions with Stiripentol or Valproate when Combined with Cannabidiol in Patients with Epilepsy. CNS Drugs. 2020 Jun;34(6):661-672. doi: 10.1007/s40263-020-00726-4.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GWP42003-P in people with Epilepsy, run by Jazz Pharmaceuticals at 5 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 20 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: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Netherlands, Sweden. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum plasma concentration (Cmax) of STP, VPA, cannabidiol (CBD). (time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02607891, which also lists 1 linked publication.
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 20 Dec 2022.