Essential TremorPhase 1/2NCT03805750
Trial of Cannabis for Essential Tremor
A Phase 1/2 study testing CBD/THC in people with Essential Tremor, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a pilot trial to evaluate the safety and efficacy of a combined oral formulation of THC and CBD in patients with Essential Tremor. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- CBD/THC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2019to 30 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ET by a Movement Disorder Neurologist
- Stable dose of tremor medication for a period of at least 6 weeks prior to screening
- Tremor in the arms
- Tremor(s) is/are moderately severe (amplitude of at least 1cm)
Who cannot join
- Significant non-ET related abnormal findings on neurological exam
- Tremor at rest, or other features suggestive of Parkinson disease
- Diagnosis of dementia
- Pregnant or nursing
- Childbearing potential and unable or unwilling to use contraception during course of the trial
- On medications known to interact with the study drug
Show all 19Show fewer
- Current or prior history of alcohol or substance abuse
- Recent exposure to primidone (within the past 21 days) or benzodiazepines (such as Valium, Ativan or Klonopin), ketoconazole, ritonavir, clarithromycin, rifampin, carbamazepine, St. Johns Wort, digoxin or other medications known to affect your liver enzymes (within the past 7 days).
- Unwilling to abstain from consuming grapefruits, grapefruit juice or grapefruit containing products.
- Taking medications such as warfarin, cyclosporine, and amphotericin B that are highly protein-bound
- Do not wish to take a cannabis-derived agent
- Allergy or sensitivity to sorbitol, xylitol, stevia or other natural sweeteners
- Allergy or sensitivity to cannabis
- Used cannabis or a cannabis-derived product (such as CBD oil) within the past 4 weeks or plan to use it during this research study.
- Diagnosis of a psychiatric disorder (e.g., mania, bipolar depressive disorder, schizophrenia, schizoaffective disorder, or other major psychiatric disorder)
- Current or prior history of suicidal thoughts and/or behavior
- Active medical problem affecting the immune system, liver, gastrointestinal tract, lungs, heart, endocrine system (such as diabetes and/or thyroid), and/or a blood clotting disorder
- Current infection
- Reduced kidney function (GFR <60)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92093
About this study
Official title: A Double-Blind, Cross-Over, Placebo- Controlled Efficacy and Tolerability Study of Oral Cannabidiol (CBD) and Tetrahydrocannabinol (THC) for Essential Tremor (ET).
This is a pilot trial to evaluate the safety and efficacy of a combined oral formulation of THC and CBD in patients with Essential Tremor.
Read the detailed description
Essential tremor (ET) is the most common neurological movement disorder, affecting up to 1% of the population and up to 5% of individuals over the age of 65. ET is characterized by often disabling tremors that occur when an individual moves. The tremors most commonly affect the hands, head, voice, and legs in order of frequency, leading to impairment in activities of daily living and morbidity. No pharmacological agent has been developed for ET, though existing agents such as propranolol and primidone are used off-label to reduce tremor amplitude. Deep brain stimulation surgery is often reserved for only individuals with the most severe tremors. Patients with ET have long reported tremor benefits with the use of cannabis, though no controlled trials have been conducted. The investigators plan to conduct the first double-blind, placebo-control clinical trial of cannabis in an oral capsule. Various validated tremor rating methods will be used to quantify tremor severity, while looking at tolerability and safety.
- Conditions
- Essential Tremor
- Being tested
- CBD/THC, Placebo oral capsule
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD/THCDrug
Also called marijuana, cannabis, cannabidiol, tetrahydrocannabinol
Oral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC).
Placebo oral capsuleDrug
Matched Placebo
| Study group | Role | What they receive |
|---|---|---|
| CBD/THC | Experimental | Treatment arm consisting of Tetrahydrocannabinol (5mg/capsule) and Cannabidiol (100mg/capsule). Receives: Drug: CBD/THC |
| Placebo | Placebo comparator | Matched placebo capsule with no active ingredients. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Spirography
The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors.
Measured: Day 22 (100 minutes post-dose)
Secondary outcomes (6)
Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS)
The performance sub scale of the TETRAS will be used to measure tremor severity. The scale ranges from 0 to 60 points (0 being no tremor).
Measured: Baseline and Day 22
Global Impression of Change
The Global impression of change will be calculated based on both physician and patient report. The scale ranges from a score of 1 (very much improved) to 7 (very much worse) with a score of 4 indicating 'no change'.
Measured: Day 22
Number of Participants Reporting Adverse Events Based on Common Terminology Criteria
Side effects survey
Measured: Days 1, 3, 6, 22
Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
This is a scale looking at risk assessment of suicidality. The presence of any positive responses will lead to further evaluation.
Measured: Day 22
Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities
Electrocardiographic changes from baseline measures will trigger further evaluation. EKG's will be rated as normal/abnormal relative to the baseline EKG reading, and abnormal findings will be rated as clinically significant/not clinically significant.
Measured: Day 22
Accelerometry-based Assessment of Tremor Severity
The spectral power density measure of accelerometry data to measure will serve as a measure of tremor severity, comparing tremor amplitude from this digital biomarker at the time of the primary outcome to the same measure at baseline.
Measured: Baseline and Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start22 Jan 2019
- Primary completion1 Sep 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- International Essential Tremor Foundation, Tilray, Center for Medicinal Cannabis Research
- Responsible party
- Principal investigator, Fatta B Nahab, University of California, San Diego
- Investigators
- Fatta Nahab, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805750
- Sponsor's protocol ID
- 180414
- Status last verified
- Oct 2022
- First submitted
- 9 Jan 2019
- Last updated
- 13 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Cross-Over, Placebo- Controlled Efficacy and Tolerability Study of Oral Cannabidiol (CBD) and Tetrahydrocannabinol (THC) for Essential Tremor (ET).
- ClinicalTrials.gov ID
- NCT03805750
- Acronym / sponsor ID
- 180414
- Conditions
- Essential Tremor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- International Essential Tremor Foundation, Tilray, Center for Medicinal Cannabis Research
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Posted 13 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot trial to evaluate the safety and efficacy of a combined oral formulation of THC and CBD in patients with Essential Tremor.
Detailed description
Essential tremor (ET) is the most common neurological movement disorder, affecting up to 1% of the population and up to 5% of individuals over the age of 65. ET is characterized by often disabling tremors that occur when an individual moves. The tremors most commonly affect the hands, head, voice, and legs in order of frequency, leading to impairment in activities of daily living and morbidity. No pharmacological agent has been developed for ET, though existing agents such as propranolol and primidone are used off-label to reduce tremor amplitude. Deep brain stimulation surgery is often reserved for only individuals with the most severe tremors. Patients with ET have long reported tremor benefits with the use of cannabis, though no controlled trials have been conducted. The investigators plan to conduct the first double-blind, placebo-control clinical trial of cannabis in an oral capsule. Various validated tremor rating methods will be used to quantify tremor severity, while looking at tolerability and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBD/THC | Experimental | Drug: CBD/THCTreatment arm consisting of Tetrahydrocannabinol (5mg/capsule) and Cannabidiol (100mg/capsule). |
| Placebo | Placebo comparator | Drug: Placebo oral capsuleMatched placebo capsule with no active ingredients. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of ET by a Movement Disorder Neurologist
- Stable dose of tremor medication for a period of at least 6 weeks prior to screening
- Tremor in the arms
- Tremor(s) is/are moderately severe (amplitude of at least 1cm)
Key exclusion criteria (19 listed)
- Significant non-ET related abnormal findings on neurological exam
- Tremor at rest, or other features suggestive of Parkinson disease
- Diagnosis of dementia
- Pregnant or nursing
- Childbearing potential and unable or unwilling to use contraception during course of the trial
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 |
|---|---|---|
| CBD/THCAlso: marijuana, cannabis, cannabidiol, tetrahydrocannabinolOral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC). | Drug | CBD/THC |
| Placebo oral capsuleMatched Placebo | Drug | Placebo |
Primary outcome
Digital Spirography
Time frame: Day 22 (100 minutes post-dose)
The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors.
6 secondary outcomes
Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS)
Time frame: Baseline and Day 22
Global Impression of Change
Time frame: Day 22
Number of Participants Reporting Adverse Events Based on Common Terminology Criteria
Time frame: Days 1, 3, 6, 22
Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 22
Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities
Time frame: Day 22
Accelerometry-based Assessment of Tremor Severity
Time frame: Baseline and Day 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study InformationLink provided by the sponsor.
- 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.
Fatta Nahab, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CBD/THC in people with Essential Tremor, run by University of California, San Diego 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 4 inclusion and 19 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 13 Oct 2022. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 13 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Digital Spirography (time frame: Day 22 (100 minutes post-dose)). 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 13 Oct 2022.