Trial of Cannabis for Essential Tremor

Essential Tremor Clinical Trial

Official title:

A Double-Blind, Cross-Over, Placebo- Controlled Efficacy and Tolerability Study of Oral Cannabidiol (CBD) and Tetrahydrocannabinol (THC) for Essential Tremor (ET).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805750
• Other study ID #: 180414
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 22, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: October 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 30, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Drug:
• CBD/THC
Oral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC).
• Placebo oral capsule
Matched Placebo

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Diego	Center for Medicinal Cannabis Research, International Essential Tremor Foundation, Tilray

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Digital Spirography	The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors.	Day 22 (100 minutes post-dose)
Secondary	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).	Baseline and Day 22
Secondary	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'.	Day 22
Secondary	Number of Participants Reporting Adverse Events Based on Common Terminology Criteria	Side effects survey	Days 1, 3, 6, 22
Secondary	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.	Day 22
Secondary	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.	Day 22
Secondary	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.	Baseline and Day 22

External Links

•   Study Information