ALSIleraNCT03886753
Pharmacokinetic (PK) and Pharmacodynamics (PD) Study of Ilera Specific Products
An observational study of ALS and Autism Spectrum Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This is an observational study of medical marijuana manufactured and dispensed by Ilera and given as standard treatment for a variety of approved serious medical conditions as defined by individual state law. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- ALS, Autism Spectrum Disorder, Cancer
- What is being tested?
- Registry and PK microsampling of blood
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 30 Jun 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients > 2 years old who are being treated with Dream, Shine, Ease or Soothe products manufactured by Ilera Healthcare for a state approved qualifying medical condition under the PA State Medical Marijuana Program.
Who may be able to join
- Individuals who consume either Dream, Shine, Soothe or Ease medical marijuana manufactured by Ilera Heath care in a state which has legalized medical marijuana for state specified serious medical conditions.
- Written informed consent and assent (if applicable)
- Patients greater than 2 years of age
Who cannot join
- Consumption of marijuana products that are not obtained from a state licensed dispensary
- Non English speaking individuals
- Have consumed a CBD/THC containing product other than the product under study within the 7 days prior to the PK study
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Pharmacokinetic and Pharmacodynamic Study of Ilera Medical Marijuana Products
This is an observational study of medical marijuana manufactured and dispensed by Ilera and given as standard treatment for a variety of approved serious medical conditions as defined by individual state law. All patients who are receiving one of the four formulations (Dream, Soothe, Shine and Ease) of medical marijuana will be provided a study flyer and asked to contact the study team via phone or email. Once the study team confirms eligibility, the study team will meet the subject face-to-face most likely at their dispensary (or other mutually agreeable location) and obtain informed consent, and assent when appropriate. Initial baseline demographic information, medical history and medication inventory will be completed. Also, since it is possible that the Investigators will enroll subjects across the region, Investigators anticipate the need to seek consent over the phone for many patients. This will be done via Skype, Go to Meeting, Facetime or similar platforms so that the Investigators can have a face to face interaction with the potential subjects. Regardless of where this discussion takes place (i.e., in person or via the web), all reasonable safeguards to ensure patient privacy will be taken. Patients or their legally authorized representative (LAR) will be given sufficient (i.e., up to several hours/days) to make a decision to participate in this study. Study staff will fax or email the consent form for their signature and no study procedures will begin until the signed consent form is received by the study team. The subjects or their LARs will be instructed on obtaining the blood samples. Blood draws will be completed in the subjects' home after one of their standard doses is taken.
Read the detailed description
This is a prospective PK/PD study that will include patients who are currently legally consuming one of the four medical marijuana formulations (Dream, Soothe, Shine and Ease) from Ilera Healthcare as part of their standard therapy for one of the state approved serious medical conditions.
Part 1 of the study consists of intake data of select subjects.
- The patients will be identified at a dispensary that offers Ilera products.
- Patients be given a flyer about the study by either study staff or dispensary staff.
- Eligible patients will be asked to contact the study team if they are interested in the study.
- If the patient is interested, a face-to-face (in person at the dispensary or in the patients home or other agreed upon location) consent/assent will be obtained.
- Also, since it is possible that Investigators will enroll subjects across the region, Investigators anticipate the need to seek consent over the phone for many patients. This will be done via Skype, Go to Meeting, Facetime or similar platforms so that the investigators can have a face to face interaction with the potential subjects. Investigators will obtain written consent in all cases. Investigators will have them sign and fax or email/scan the signed consent form back to the study team.
- Once consent is obtained demographic information will be collected as well as a medical and medication history and several questions related specifically to the medical marijuana product and its perceived effectiveness.
- The data will be recorded in the REDCAP database. Part 2 of the study consists of pharmacokinetic evaluation of select subjects.
- Parents/ care providers/ patients when appropriate will undergo education regarding PK sample acquisition
- PK blood samples will be obtained and sent to the Children's Hospital of Philadelphia (CHOP) for determination of cannibidiol/ Tetrahydrocannabinol/ cannabinol (CBD/THC/CBN) concentrations
- PK and PD analysis will occur
- Conditions
- ALS, Autism Spectrum Disorder, Cancer, Spasticity, Muscle, Dyskinetic Syndrome, Epilepsy
- Being tested
- Registry, PK microsampling of blood
- Medical subject headings
- Autism Spectrum Disorder, Neoplasms, Muscle Spasticity, Dyskinesias, Epilepsy, Glaucoma, Huntington Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
Collect data on subjects
PK microsampling of bloodOther
Obtain 5 microsamples of blood from subjects via a fingerstick.
| Study group | Role | What they receive |
|---|---|---|
| Ease | Subjects using Ease as standard treatment. Registry and PK sampling Receives: Other: Registry; Other: PK microsampling of blood | |
| Dream | Subjects using Dream as standard treatment. Registry and PK sampling Receives: Other: Registry; Other: PK microsampling of blood | |
| Soothe | Subjects using Soothe as standard treatment. Registry and PK sampling Receives: Other: Registry; Other: PK microsampling of blood | |
| Shine | Those subjects using Shine as standard treatment. Registry and PK sampling Receives: Other: Registry; Other: PK microsampling of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms
Relief of primary indication (perceived therapeutic benefit of product)as reported by parent or caregiver on a 1-10 Lichert scale with 1 being minimally effective and 10 being extremely effective
Measured: 1 year
Secondary outcomes (7)
Description and incidence of patient or caregiver reported side effects
There is no particular instrument used in collecting this data. It is an open ended question where by patients and caregivers report possible side effects from the medical marijuana. Investigators will report the incidence in percentages.
Measured: 1 year
Changes in drug concentrations
The amount of a drug in a given volume of blood plasma, measured as the number of micrograms per milliliter
Measured: 2 years
Rate of bioavailabilty
The degree and rate at which the medication is absorbed by the body's circulatory system, the systemic circulation.
Measured: 2 years
Volume of distribution
The volume of medication that would be necessary to contain the total amount of the administered drug at the same concentration that it is observed in the blood plasma.
Measured: 2 years
Report area under the plasma concentration versus time curve (AUC)
The area under the curve (AUC) is the definite integral in a plot of drug concentration in blood plasma vs. time
Measured: 2 years
Report half-life
Half life is described as how long it takes for half of the dose to be metabolized and eliminated from the bloodstream.
Measured: 2 years
Assess therapeutic range
Comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start15 May 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Ilera Healthcare
- Responsible party
- Sponsor
- Investigators
- Athena F Zuppa, MD MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886753
- Sponsor's protocol ID
- 18-015787
- Acronym
- Ilera
- Status last verified
- Jul 2020
- First submitted
- 14 Jan 2019
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Study of Ilera Medical Marijuana Products
- ClinicalTrials.gov ID
- NCT03886753
- Acronym / sponsor ID
- Ilera / 18-015787
- Conditions
- ALS, Autism Spectrum Disorder, Cancer, Spasticity, Muscle, Dyskinetic Syndrome, Epilepsy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Feasibility
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Ilera Healthcare
- Study start
- 15 May 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 Mar 2019 (actual)
- 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 study of medical marijuana manufactured and dispensed by Ilera and given as standard treatment for a variety of approved serious medical conditions as defined by individual state law. All patients who are receiving one of the four formulations (Dream, Soothe, Shine and Ease) of medical marijuana will be provided a study flyer and asked to contact the study team via phone or email. Once the study team confirms eligibility, the study team will meet the subject face-to-face most likely at their dispensary (or other mutually agreeable location) and obtain informed consent, and assent when appropriate. Initial baseline demographic information, medical history and medication inventory will be completed. Also, since it is possible that the Investigators will enroll subjects across the region, Investigators anticipate the need to seek consent over the phone for many patients. This will be done via Skype, Go to Meeting, Facetime or similar platforms so that the Investigators can have a face to face interaction with the potential subjects. Regardless of where this discussion takes place (i.e., in person or via the web), all reasonable safeguards to ensure patient privacy will be taken. Patients or their legally authorized representative (LAR) will be given sufficient (i.e., up to several hours/days) to make a decision to participate in this study. Study staff will fax or email the consent form for their signature and no study procedures will begin until the signed consent form is received by the study team. The subjects or their LARs will be instructed on obtaining the blood samples. Blood draws will be completed in the subjects' home after one of their standard doses is taken.
Detailed description
This is a prospective PK/PD study that will include patients who are currently legally consuming one of the four medical marijuana formulations (Dream, Soothe, Shine and Ease) from Ilera Healthcare as part of their standard therapy for one of the state approved serious medical conditions.
Part 1 of the study consists of intake data of select subjects.
- The patients will be identified at a dispensary that offers Ilera products.
- Patients be given a flyer about the study by either study staff or dispensary staff.
- Eligible patients will be asked to contact the study team if they are interested in the study.
- If the patient is interested, a face-to-face (in person at the dispensary or in the patients home or other agreed upon location) consent/assent will be obtained.
- Also, since it is possible that Investigators will enroll subjects across the region, Investigators anticipate the need to seek consent over the phone for many patients. This will be done via Skype, Go to Meeting, Facetime or similar platforms so that the investigators can have a face to face interaction with the potential subjects. Investigators will obtain written consent in all cases. Investigators will have them sign and fax or email/scan the signed consent form back to the study team.
- Once consent is obtained demographic information will be collected as well as a medical and medication history and several questions related specifically to the medical marijuana product and its perceived effectiveness.
- The data will be recorded in the REDCAP database. Part 2 of the study consists of pharmacokinetic evaluation of select subjects.
- Parents/ care providers/ patients when appropriate will undergo education regarding PK sample acquisition
- PK blood samples will be obtained and sent to the Children's Hospital of Philadelphia (CHOP) for determination of cannibidiol/ Tetrahydrocannabinol/ cannabinol (CBD/THC/CBN) concentrations
- PK and PD analysis will occur
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ease | – | Other: Registry, Other: PK microsampling of bloodSubjects using Ease as standard treatment. Registry and PK sampling |
| Dream | – | Other: Registry, Other: PK microsampling of bloodSubjects using Dream as standard treatment. Registry and PK sampling |
| Soothe | – | Other: Registry, Other: PK microsampling of bloodSubjects using Soothe as standard treatment. Registry and PK sampling |
| Shine | – | Other: Registry, Other: PK microsampling of bloodThose subjects using Shine as standard treatment. Registry and PK sampling |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients > 2 years old who are being treated with Dream, Shine, Ease or Soothe products manufactured by Ilera Healthcare for a state approved qualifying medical condition under the PA State Medical Marijuana Program.
Key inclusion criteria (3 listed)
- Individuals who consume either Dream, Shine, Soothe or Ease medical marijuana manufactured by Ilera Heath care in a state which has legalized medical marijuana for state specified serious medical conditions.
- Written informed consent and assent (if applicable)
- Patients greater than 2 years of age
Key exclusion criteria (3 listed)
- Consumption of marijuana products that are not obtained from a state licensed dispensary
- Non English speaking individuals
- Have consumed a CBD/THC containing product other than the product under study within the 7 days prior to the PK study
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 |
|---|---|---|
| RegistryCollect data on subjects | Other | Dream, Ease, Shine, Soothe |
| PK microsampling of bloodObtain 5 microsamples of blood from subjects via a fingerstick. | Other | Dream, Ease, Shine, Soothe |
Primary outcome
Change in symptoms
Time frame: 1 year
Relief of primary indication (perceived therapeutic benefit of product)as reported by parent or caregiver on a 1-10 Lichert scale with 1 being minimally effective and 10 being extremely effective
7 secondary outcomes
Description and incidence of patient or caregiver reported side effects
Time frame: 1 year
Changes in drug concentrations
Time frame: 2 years
Rate of bioavailabilty
Time frame: 2 years
Volume of distribution
Time frame: 2 years
Report area under the plasma concentration versus time curve (AUC)
Time frame: 2 years
Report half-life
Time frame: 2 years
Assess therapeutic range
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Feasibility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- 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.
Athena F Zuppa, MD MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS and Autism Spectrum Disorder, run by Children's Hospital of Philadelphia 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 30 Jul 2020. 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?
The study was stopped early (reason given: Feasibility). 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?
Change in symptoms (time frame: 1 year). 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 30 Jul 2020.