EpilepsyPhase 2NCT02607904
An Open-label Extension Trial to Investigate 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 open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. 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?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 15 Dec 2016to 27 May 2019
- 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 have a documented magnetic resonance imaging/computerized tomography of the brain that ruled out a progressive neurologic condition.
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 any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month.
- Participant is currently using felbamate and has been taking it for less than 12 months prior to screening visit of the blinded phase of the trial.
- 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 trial.
- Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP), e.g., sesame oil.
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 open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.
- Conditions
- Epilepsy
- Being tested
- GWP42003-P
- 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 (CBD) dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
| Study group | Role | What they receive |
|---|---|---|
| GWP42003-P | Experimental | Administered orally, twice daily (morning and evening), commencing with titration of 100 mg/mL GWP42003-P to 20 mg/kg/day over 10 days in a blinded manner (i.e., only participants taking placebo in the blinded phase will up-titrate; doses will remain unchanged for those taking GWP42003-P in the blinded phase).
Participants remain on the maintenance dose for the remainder of the 48-week treatment period, until early withdrawal or at an early study conclusion date defined by the sponsor. However, investigators may subsequently decrease or increase the participant's dose (to a maximum of 30 mg/kg/day) until the optimum dose is found.
Dosing is tapered (10% each day) for participants who do not immediately continue to use GWP42003-P once market authorization is granted, or for those who withdraw early. Receives: Drug: GWP42003-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 48 weeks.
Secondary outcomes (9)
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 48 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 48 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 48 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 48 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 48 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 48 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 48 weeks.
Seizure frequency by subtype.
The frequency of each subtype of seizure at baseline and end of treatment is presented.
Measured: Up to 48 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 48 weeks.
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 start15 Dec 2016
- Primary completion27 May 2019
- Study completion27 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT02607904
- Sponsor's protocol ID
- GWEP1447 Open-label Extension
- 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
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
- NCT02607904
- Acronym / sponsor ID
- GWEP1447 Open-label Extension
- Conditions
- Epilepsy
- Keywords
- Cannabidiol, GWP42003-P, Epidiolex, Stiripentol, Valproate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 27 May 2019 (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 open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.
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-PAdministered orally, twice daily (morning and evening), commencing with titration of 100 mg/mL GWP42003-P to 20 mg/kg/day over 10 days in a blinded manner (i.e., only participants taking placebo in the blinded phase will up-titrate; doses will remain unchanged for those taking GWP42003-P in the blinded phase). Participants remain on the maintenance dose for the remainder of the 48-week treatment period, until early withdrawal or at an early study conclusion date defined by the sponsor. However, investigators may subsequently decrease or increase the participant's dose (to a maximum of 30 mg/kg/day) until the optimum dose is found. Dosing is tapered (10% each day) for participants who do not immediately continue to use GWP42003-P once market authorization is granted, or for those who withdraw early. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participant must have a documented magnetic resonance imaging/computerized tomography of the brain that ruled out a progressive neurologic condition.
Key exclusion criteria (8 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 any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month.
- Participant is currently using felbamate and has been taking it for less than 12 months prior to screening visit of the blinded phase of the trial.
- 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.
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 (CBD) dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. | Drug | GWP42003-P |
Primary outcome
Number of participants who experienced an adverse event.
Time frame: Up to 48 weeks.
The number of participants who experienced an adverse event during the trial is presented.
9 secondary outcomes
Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG).
Time frame: Up to 48 weeks.
Number of participants with a clinically significant change in serum biochemistry.
Time frame: Up to 48 weeks.
Number of participants with a clinically significant change in hematology.
Time frame: Up to 48 weeks.
Number of participants with a clinically significant change in urinalysis.
Time frame: Up to 48 weeks.
Number of participants with a clinically significant change in vital signs.
Time frame: Up to 48 weeks.
Number of participants with a clinically significant change in physical examination.
Time frame: Up to 48 weeks.
Number of participants with a treatment-emergent suicidality flag.
Time frame: Up to 48 weeks.
Seizure frequency by subtype.
Time frame: Up to 48 weeks.
Number of participants with a treatment-emergent finding indicative of drug abuse liability.
Time frame: Up to 48 weeks.
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.
- Individual participant dataSharing planned: No
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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.
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 1 inclusion and 8 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. 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?
Number of participants who experienced an adverse event. (time frame: Up to 48 weeks.). 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 20 Dec 2022.