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Trial of Cannabis for Essential Tremor

Primary Purpose

Essential Tremor

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBD/THC
Placebo oral capsule
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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)

Sites / Locations

  • University of California San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CBD/THC

Placebo

Arm Description

Treatment arm consisting of Tetrahydrocannabinol (5mg/capsule) and Cannabidiol (100mg/capsule).

Matched placebo capsule with no active ingredients.

Outcomes

Primary Outcome Measures

Digital Spirography
The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors.

Secondary Outcome Measures

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).
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'.
Number of Participants Reporting Adverse Events Based on Common Terminology Criteria
Side effects survey
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.
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.
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.

Full Information

First Posted
January 9, 2019
Last Updated
October 9, 2022
Sponsor
University of California, San Diego
Collaborators
International Essential Tremor Foundation, Tilray, Center for Medicinal Cannabis Research
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1. Study Identification

Unique Protocol Identification Number
NCT03805750
Brief Title
Trial of Cannabis for Essential Tremor
Official Title
A Double-Blind, Cross-Over, Placebo- Controlled Efficacy and Tolerability Study of Oral Cannabidiol (CBD) and Tetrahydrocannabinol (THC) for Essential Tremor (ET).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
International Essential Tremor Foundation, Tilray, Center for Medicinal Cannabis Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBD/THC
Arm Type
Experimental
Arm Description
Treatment arm consisting of Tetrahydrocannabinol (5mg/capsule) and Cannabidiol (100mg/capsule).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo capsule with no active ingredients.
Intervention Type
Drug
Intervention Name(s)
CBD/THC
Other Intervention Name(s)
marijuana, cannabis, cannabidiol, tetrahydrocannabinol
Intervention Description
Oral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC).
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Matched Placebo
Primary Outcome Measure Information:
Title
Digital Spirography
Description
The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors.
Time Frame
Day 22 (100 minutes post-dose)
Secondary Outcome Measure Information:
Title
Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS)
Description
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).
Time Frame
Baseline and Day 22
Title
Global Impression of Change
Description
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'.
Time Frame
Day 22
Title
Number of Participants Reporting Adverse Events Based on Common Terminology Criteria
Description
Side effects survey
Time Frame
Days 1, 3, 6, 22
Title
Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
This is a scale looking at risk assessment of suicidality. The presence of any positive responses will lead to further evaluation.
Time Frame
Day 22
Title
Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities
Description
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.
Time Frame
Day 22
Title
Accelerometry-based Assessment of Tremor Severity
Description
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.
Time Frame
Baseline and Day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatta Nahab, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://tremor.cmcr.ucsd.edu
Description
Study Information

Learn more about this trial

Trial of Cannabis for Essential Tremor

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