Drug Resistant EpilepsyNCT03014440
Study of Cannabidiol for Drug-Resistant Epilepsies
A study testing Cannabidiol in people with Drug Resistant Epilepsy, run by Eric Marsh, MD.
Trial summary
The purpose of this study is to determine if cannabidiol is safe and effective at different doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure frequency. Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- Cannabidiol
- How many people
- Not given
- Where
- No sites listed yet
- 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 20 years
- All sexes
- Child, Adult
Who may be able to join
- Ages between 1 year old and 20 years old, male or female at the first visit, Week -4 (at time informed consent form is signed)
- Documentation of a diagnosis of drug-resistant epilepsy as proven by and documented with medical records and/or the following clinical features (must have all 3 of the following):
- Failure to control seizures despite appropriate trial of 3 or more AEDs at therapeutic doses
- An intractable childhood epilepsy including, Dravet Syndrome or Lennox-Gastaut Syndrome
- Must report at least 3 countable (non-countable seizures includes absence and myoclonic) seizures per month
- Between 1-3 baseline AEDs . Vagus nerve stimulator (VNS), ketogenic diet, and modified Atkins diet do not count towards this limit.
- VNS must be on stable settings for a minimum of 3 months.
- If on the ketogenic diet, must be on stable ratio for a minimum of 3 months.
Who cannot join
- Epilepsies associated with neurodegenerative diseases, including neuronal ceroidolipofuscinosis, progressive myoclonus epilepsies, Rasmussen encephalitis, and tumors
- Epilepsies associated with an inborn error of metabolism, including mitochondrial disorders
- Felbatol initiated within the past 12 months
- Use of any Cannabis-related product (including hemp oil) in the past 12 months as assessed by parental questioning.
- Laboratory values on comprehensive metabolic panel (CMP) and complete blood count (CBC) testing that are Class 3 or higher according to the CTCAE v4.0.
- Positive pregnancy test.
About this study
Official title: A Phase 1/2, Safety, Tolerability, and Dose-Finding Study of Cannabidiol for Drug-Resistant Epilepsies
The purpose of this study is to determine if cannabidiol is safe and effective at different doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure frequency. There are only a few open label studies that have demonstrated the safety and tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies were performed either retrospectively or with varying cannabidiol preparations. There are no well-documented studies and completely analyzed data for pediatric epileptic patients.
- Conditions
- Drug Resistant Epilepsy
- Being tested
- Cannabidiol
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD, Epidiolex
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Eric Marsh, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Geisinger Clinic
- Responsible party
- Sponsor-investigator, Eric Marsh, MD, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014440
- Sponsor's protocol ID
- 13-010562
- Status last verified
- Mar 2017
- First submitted
- 5 Jan 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Safety, Tolerability, and Dose-Finding Study of Cannabidiol for Drug-Resistant Epilepsies
- ClinicalTrials.gov ID
- NCT03014440
- Acronym / sponsor ID
- 13-010562
- Conditions
- Drug Resistant Epilepsy
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Eric Marsh, MDUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Geisinger Clinic
- First posted
- 9 Jan 2017 (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 determine if cannabidiol is safe and effective at different doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure frequency. There are only a few open label studies that have demonstrated the safety and tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies were performed either retrospectively or with varying cannabidiol preparations. There are no well-documented studies and completely analyzed data for pediatric epileptic patients.
Study design
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Ages between 1 year old and 20 years old, male or female at the first visit, Week -4 (at time informed consent form is signed)
- Documentation of a diagnosis of drug-resistant epilepsy as proven by and documented with medical records and/or the following clinical features (must have all 3 of the following):
- Between 1-3 baseline AEDs . Vagus nerve stimulator (VNS), ketogenic diet, and modified Atkins diet do not count towards this limit.
- VNS must be on stable settings for a minimum of 3 months.
- If on the ketogenic diet, must be on stable ratio for a minimum of 3 months.
Key exclusion criteria (6 listed)
- Epilepsies associated with neurodegenerative diseases, including neuronal ceroidolipofuscinosis, progressive myoclonus epilepsies, Rasmussen encephalitis, and tumors
- Epilepsies associated with an inborn error of metabolism, including mitochondrial disorders
- Felbatol initiated within the past 12 months
- Use of any Cannabis-related product (including hemp oil) in the past 12 months as assessed by parental questioning.
- Laboratory values on comprehensive metabolic panel (CMP) and complete blood count (CBC) testing that are Class 3 or higher according to the CTCAE v4.0.
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: CBD, Epidiolex | 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 4 Apr 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabidiol in people with Drug Resistant Epilepsy, run by Eric Marsh, MD.
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 8 inclusion and 6 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 4 Apr 2017.