EpilepsyPhase 3NCT02783092
A Double-Blind Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epilepsy
A Phase 3 study testing Cannabidiol in people with Epilepsy, run by Antonio Waldo Zuardi at 1 site in Brazil.
Trial summary
The purpose of this study is to assess the efficacy of the adjuvant use of cannabidiol administered twice daily in doses of 5-25 mg/kg/day through the proportion of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Jan 2019to 25 Sep 2024
- Phase
- Phase 3
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Men and women aged 2 years to 18 years.
- Diagnosis of treatment-resistant epilepsy according to the criteria of the International League Against Epilepsy (ILAE) (Kwan et al., 2010).
- Participants with at least 4 epileptic seizures with intervals no longer than 21 days.
- In treatment with up to 3 AEDs concomitantly and at stable doses for at least 1 month before the baseline assessment and expected to remain stable during the period of the trial. Vagus nerve stimulation (VNS) will be considered as an AED.
- Availability of a legal guardian able to follow the protocol (e.g., understand and fill up diaries) and visitation and medication schemes, according to the decision of the investigator.
- Availability of brain neuroimaging exams (magnetic resonance or computed tomography) collected within the last 5 years.
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- No significant comorbid conditions, according to medical decision, to other criteria in this Protocol, and to additional assessments: medical records, blood pressure, heart rate, and temperature measures, physical exam, ECG, EEG, and laboratory tests.
- Women in reproductive age may be included as long as they are sexually abstinent or using effective contraceptive methods.
- Participants and their legal guardians, when applicable, must sign an informed consent form approved by the local ethics committee.
Who cannot join
- Occurrence of simple partial seizures (preserved consciousness) only, with no motor symptomatology.
- History or presence of pseudoseizures.
- History of suicide attempt.
- History of major depression.
- Pregnancy.
- Drug use.
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- Hypertension.
- Participants with severe dysphagia and no gastric or nasogastric tubes.
- Current treatment with drugs that may significantly affect the metabolism of CBD, except AEDs if stable for at least 1 month before the screening interview.
- Presence of any clinical or neuroimaging finding suggestive of brain disorders, brain tumors, or metabolic or neurodegenerative diseases of rapid progression.
- Presence of acute and clinically significant diseases as assessed by a medical investigator, such as kidney, liver, urinary, bowel, or respiratory infections.
- Presence of known chronic and clinically significant diseases as assessed by a medical investigator and which may interfere with participation in the trial or pose safety risks for the participant.
- History of liver, kidney, lung, hematological, heart, or psychiatric diseases that may affect the volunteers' health or participation in the trial.
- Hypotension or hypertension with any etiology and requiring pharmacological management.
- History of surgeries that may affect the volunteers' health and/or participation in the trial.
- Regular or intermittent use of marijuana over the 60 days preceding the baseline assessment.
- Regular or intermittent treatment with CBD over the 60 days preceding the baseline assessment.
- History of allergies or idiosyncratic reactions to Cannabis sativa derivatives or components of the pharmaceutical formulation.
- Clinically significant ECG alterations as judged by a medical investigator.
- Participation in other clinical trials within less than 3 months before the baseline assessment.
- Donation or loss of 450 mL or more of blood within 90 days before the baseline assessment.
- Impaired liver function: AST, ALP, alkaline phosphatase and γGT values more than 3 times above the upper limit of the reference value. Results of γGT values 3 times above the upper limit will only be accepted if attributable to liver enzymatic induction caused by concomitant treatment with AEDs and with levels of other liver enzymes lower than 3 times the upper limit of the reference range.
- Participants with clinically significant discrepancies from the reference ranges of the following laboratory tests: creatinine clearance < 50 ml/min, platelets < 100.000/μL, and neutrophils < 1.800/μL.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Unidade de Pesquisa Clínica HCRP-USP
Ribeirão Preto, São Paulo, 14048900
About this study
Official title: A Double-blind, Randomized Placebo-controlled Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epileptic Crisis in Children and Adolescents
The purpose of this study is to assess the efficacy of the adjuvant use of cannabidiol administered twice daily in doses of 5-25 mg/kg/day through the proportion of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).
Primary end point(s): Rate of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).
- Conditions
- Epilepsy
- Being tested
- Cannabidiol, Placebo
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
Oral solution of cannabidiol 200 mg / mL dissolved in corn oil. Titration period: 5 mg / kg / day up to 25 mg / kg / day. Maintenance period: highest dose obtained during the titration period (maximum of 25 mg/kg / day)
PlaceboDrug
Also called PLC
The placebo will be an oral solution of corn oil. Titration period: 5 mg / kg / day up to 25 mg / kg / day. Maintenance period: highest dose obtained during the titration period (maximum of 25 mg/kg / day)
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | Concentration unit: 200mg/ml; 5 - 25 mg/Kg/day ; Oral solution Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | Oral solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of epileptic seizures
Measured: 17 th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start9 Jan 2019
- Primary completion10 Jul 2024 (estimated)
- Study completion25 Sep 2024 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antonio Waldo Zuardi
- Sponsor type
- University, hospital or other
- Collaborators
- Prati Donaduzzi & Cia Ltda
- Responsible party
- Sponsor-investigator, Antonio Waldo Zuardi, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783092
- Sponsor's protocol ID
- CBD-PRATI-USP_01
- Status last verified
- May 2023
- First submitted
- 23 May 2016
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Placebo-controlled Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epileptic Crisis in Children and Adolescents
- ClinicalTrials.gov ID
- NCT02783092
- Acronym / sponsor ID
- CBD-PRATI-USP_01
- Conditions
- Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Antonio Waldo ZuardiUniversity, hospital or other
- Collaborators
- Prati Donaduzzi & Cia Ltda
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 25 Sep 2024 (estimated)
- First posted
- 26 May 2016 (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.
The purpose of this study is to assess the efficacy of the adjuvant use of cannabidiol administered twice daily in doses of 5-25 mg/kg/day through the proportion of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).
Primary end point(s): Rate of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Drug: CannabidiolConcentration unit: 200mg/ml; 5 - 25 mg/Kg/day ; Oral solution |
| Placebo | Placebo comparator | Drug: PlaceboOral solution |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Men and women aged 2 years to 18 years.
- Diagnosis of treatment-resistant epilepsy according to the criteria of the International League Against Epilepsy (ILAE) (Kwan et al., 2010).
- Participants with at least 4 epileptic seizures with intervals no longer than 21 days.
- In treatment with up to 3 AEDs concomitantly and at stable doses for at least 1 month before the baseline assessment and expected to remain stable during the period of the trial. Vagus nerve stimulation (VNS) will be considered as an AED.
- Availability of a legal guardian able to follow the protocol (e.g., understand and fill up diaries) and visitation and medication schemes, according to the decision of the investigator.
Key exclusion criteria (23 listed)
- Occurrence of simple partial seizures (preserved consciousness) only, with no motor symptomatology.
- History or presence of pseudoseizures.
- History of suicide attempt.
- History of major depression.
- Pregnancy.
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 |
|---|---|---|
| CannabidiolAlso: CBDOral solution of cannabidiol 200 mg / mL dissolved in corn oil. Titration period: 5 mg / kg / day up to 25 mg / kg / day. Maintenance period: highest dose obtained during the titration period (maximum of 25 mg/kg / day) | Drug | Cannabidiol |
| PlaceboAlso: PLCThe placebo will be an oral solution of corn oil. Titration period: 5 mg / kg / day up to 25 mg / kg / day. Maintenance period: highest dose obtained during the titration period (maximum of 25 mg/kg / day) | Drug | Placebo |
Primary outcome
Frequency of epileptic seizures
Time frame: 17 th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cannabidiol in people with Epilepsy, run by Antonio Waldo Zuardi at 1 site in Brazil.
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 9 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 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?
Results are not available in the source record.
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?
Frequency of epileptic seizures (time frame: 17 th week). 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 29 Nov 2023.