EpilepsyCBDNCT02660255
Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy
A study testing Cannabidiol in people with Epilepsy, run by University of Nebraska at 1 site in United States.
Trial summary
This is an observational, open-label, flexible dose study that will prospectively and longitudinally assess the effect of Cannabidiol (CBD) therapy in patients with drug-resistant epilepsies through a Physician Expanded Access Investigational New Drug protocol. Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Cannabidiol
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 1 year to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 1-60 years of age.
- Patient must have at least 4 clinically countable seizures per month. They must also have prior concomitant video-EEG with evidence documenting a diagnosis of epilepsy. Seizure history to include a documented history of generalized seizures (drop attacks, atonic, tonic-clonic and/or myoclonic), focal seizures without loss of consciousness with a motor component, focal seizures with loss of consciousness, or focal seizures with secondary generalization.
- Drug resistant epilepsy defined as a trial of at least four drugs, including one trial of a combination of two concomitant drugs, without successful seizure control. Vagal nerve stimulation, responsive neurostimulation, RNS, deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial and documented evidence of drug and other therapeutic failures.
- Between 1-4 baseline anti-epileptic drugs at time of enrollment. Vagus nerve stimulator (VNS), ketogenic diet and modified Atkins diet do not count toward this limit and are not contraindicated for inclusion.
- Subject and family sign assent (if capable)/consent/research authorization and are able to meet the study expectations for appointments for the duration of the study
- VNS, if in use must be on stable settings for a minimum of 1 month.
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- If on ketogenic diet, must be on stable ratio for a minimum of 3 months.
- Patients or their caregivers must be able to consistently maintain a seizure diary for at least 2 months prior to enrollment and during the course of the study period.
- Must be Nebraska state resident.
Who cannot join
- Renal, hepatic, pancreatic, or hematologic dysfunction as evidenced by: values above upper limits of normal for blood urea nitrogen (BUN)/creatinine, or values twice the upper limit of normal for serum transaminases [alanine transaminase (ALT), serum glutamic pyruvic transaminase (SGPT), aspartate transaminase (AST), serum glutamic-oxaloacetic transaminase (SGOT)], values twice the upper limit of normal for serum lipase and amylase, platelets <80,000 /miroliter (mcL), white blood cell count (WBC)<3.0 103 /mcL
- Less than 4 countable (non-countable seizures includes absence and myoclonic) seizures per month
- Use of cannabis-related product within last 30 days
- Active substance abuse/addiction.
- CBD is contraindicated in pregnancy and breastfeeding. Female subjects who are pregnant will be excluded from the study. If a female subject is able to become pregnant, she will be given a urine pregnancy test before entry into the study. Female subjects will be informed not to become pregnant while taking cannabidiol, and must agree to an acceptable method of barrier contraception use during the study which should include abstinence or a double barrier method for the duration of treatment.
- Female subjects must tell the investigator and consult an obstetrician or maternal-fetal specialist if they become pregnant during the study. If pregnancy occurs, CBD will be stopped in the most clinically appropriate manner.
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- Allergy to CBD or any cannabinoid.
- Unable to provide consent and no Legally Authorized Representative (LAR) available
- Unable to comply with study visits/requirements.
- Use of alcohol
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
This is an observational, open-label, flexible dose study that will prospectively and longitudinally assess the effect of Cannabidiol (CBD) therapy in patients with drug-resistant epilepsies through a Physician Expanded Access Investigational New Drug protocol.
Read the detailed description
This study will test if Cannabidiol (CBD) therapy is safe in humans and reduces the number and/or severity of seizures in patients with drug resistant epilepsy when taken in addition to current anti-epileptic drugs (AEDs).
To be eligible, subjects must:
- have drug-resistant epilepsy
- be between 1 and 60 years of age
Subjects may participate for up to 2 years and may continue to receive the drug as available, until the compassionate use is terminated or the drug becomes approved by the FDA.
The study includes:
- Baseline, Screening and 2 phone calls
- 12 week drug titration (6 visits) and 5 phone calls
- Approximately 1 year and 9 month Treatment period (7 visits)
Subjects will come in for visits approximately every two weeks for the first three months and then quarterly for the remainder of the study. Subjects' antiepileptic drug levels will be tested to monitor for drug interactions. Lab assessments (complete blood count,CBC; comprehensive metabolic panel, CMP; urinalysis) will be performed to monitor for changes in bone marrow, liver, and kidney function to ensure safe use.
Cannabidiol will be in the form of 100 mg/ml oral solution. Subjects will be given CBD to take in addition to their current anti-epileptic drug (AED) regimen.
- Conditions
- Epilepsy
- Being tested
- Cannabidiol
- Keywords
- CBD, Epidiolex, Myoclonic, Brain Disease, Central Nervous System Disease, GWP42003
- Medical subject headings
- Epilepsy, Brain Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called Epidiolex
Formulation: 100mg/ml CBD (Epidiolex) Solution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (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.
- More trials run by University of NebraskaThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Deepak Madhavan, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660255
- Sponsor's protocol ID
- 0719-15-FB
- Acronym
- CBD
- Status last verified
- Oct 2023
- First submitted
- 21 Dec 2015
- Last updated
- 10 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT02660255
- Acronym / sponsor ID
- CBD / 0719-15-FB
- Conditions
- Epilepsy
- Keywords
- CBD, Epidiolex, Myoclonic, Brain Disease, Central Nervous System Disease, GWP42003
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- First posted
- 21 Jan 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.
This is an observational, open-label, flexible dose study that will prospectively and longitudinally assess the effect of Cannabidiol (CBD) therapy in patients with drug-resistant epilepsies through a Physician Expanded Access Investigational New Drug protocol.
Detailed description
This study will test if Cannabidiol (CBD) therapy is safe in humans and reduces the number and/or severity of seizures in patients with drug resistant epilepsy when taken in addition to current anti-epileptic drugs (AEDs).
To be eligible, subjects must:
- have drug-resistant epilepsy
- be between 1 and 60 years of age
Subjects may participate for up to 2 years and may continue to receive the drug as available, until the compassionate use is terminated or the drug becomes approved by the FDA.
The study includes:
- Baseline, Screening and 2 phone calls
- 12 week drug titration (6 visits) and 5 phone calls
- Approximately 1 year and 9 month Treatment period (7 visits)
Subjects will come in for visits approximately every two weeks for the first three months and then quarterly for the remainder of the study. Subjects' antiepileptic drug levels will be tested to monitor for drug interactions. Lab assessments (complete blood count,CBC; comprehensive metabolic panel, CMP; urinalysis) will be performed to monitor for changes in bone marrow, liver, and kidney function to ensure safe use.
Cannabidiol will be in the form of 100 mg/ml oral solution. Subjects will be given CBD to take in addition to their current anti-epileptic drug (AED) regimen.
Study design
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Ages 1-60 years of age.
- Patient must have at least 4 clinically countable seizures per month. They must also have prior concomitant video-EEG with evidence documenting a diagnosis of epilepsy. Seizure history to include a documented history of generalized seizures (drop attacks, atonic, tonic-clonic and/or myoclonic), focal seizures without loss of consciousness with a motor component, focal seizures with loss of consciousness, or focal seizures with secondary generalization.
- Drug resistant epilepsy defined as a trial of at least four drugs, including one trial of a combination of two concomitant drugs, without successful seizure control. Vagal nerve stimulation, responsive neurostimulation, RNS, deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial and documented evidence of drug and other therapeutic failures.
- Between 1-4 baseline anti-epileptic drugs at time of enrollment. Vagus nerve stimulator (VNS), ketogenic diet and modified Atkins diet do not count toward this limit and are not contraindicated for inclusion.
- Subject and family sign assent (if capable)/consent/research authorization and are able to meet the study expectations for appointments for the duration of the study
Key exclusion criteria (10 listed)
- Renal, hepatic, pancreatic, or hematologic dysfunction as evidenced by: values above upper limits of normal for blood urea nitrogen (BUN)/creatinine, or values twice the upper limit of normal for serum transaminases [alanine transaminase (ALT), serum glutamic pyruvic transaminase (SGPT), aspartate transaminase (AST), serum glutamic-oxaloacetic transaminase (SGOT)], values twice the upper limit of normal for serum lipase and amylase, platelets <80,000 /miroliter (mcL), white blood cell count (WBC)<3.0 103 /mcL
- Less than 4 countable (non-countable seizures includes absence and myoclonic) seizures per month
- Use of cannabis-related product within last 30 days
- Active substance abuse/addiction.
- CBD is contraindicated in pregnancy and breastfeeding. Female subjects who are pregnant will be excluded from the study. If a female subject is able to become pregnant, she will be given a urine pregnancy test before entry into the study. Female subjects will be informed not to become pregnant while taking cannabidiol, and must agree to an acceptable method of barrier contraception use during the study which should include abstinence or a double barrier method for the duration of treatment.
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: EpidiolexFormulation: 100mg/ml CBD (Epidiolex) Solution | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 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.
Deepak Madhavan, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabidiol in people with Epilepsy, run by University of Nebraska at 1 site in United States.
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 10 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 10 Oct 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 United States. 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.
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.
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 10 Oct 2023.