Trial of Cannabis for Essential Tremor

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

Sponsors

Lead Sponsor: University of California, San Diego

Collaborator: International Essential Tremor Foundation
Tilray
Center for Medicinal Cannabis Research

Source University of California, San Diego
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.

Overall Status Recruiting
Start Date January 22, 2019
Completion Date December 2020
Primary Completion Date September 2020
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Digital spirography Day 22
Secondary Outcome
Measure Time Frame
Tremor Research Group Essential Tremor Rating Scale (TETRAS) Day 22
Global Impression of Change Day 22
Common Terminology Criteria for Adverse Events Days 1, 3, 6, 22
Columbia-Suicide Severity Rating Scale (C-SSRS) Day 22
EKG Day 22
Accelerometry Day 22
Enrollment 16
Condition
Intervention

Intervention Type: Drug

Intervention Name: CBD/THC

Description: Oral formulation of CBD and THC.

Arm Group Label: CBD/THC

Intervention Type: Drug

Intervention Name: Placebo oral capsule

Description: Placebo

Arm Group Label: Placebo

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)

Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Fatta Nahab, MD Principal Investigator UCSD
Overall Contact

Last Name: Len Lazaro

Phone: 858-822-3708

Email: [email protected]

Location
Facility: Status: Contact: Investigator: University of California San Diego Len Lazaro 858-822-3708 [email protected] Fatta Nahab, MD Principal Investigator
Location Countries

United States

Verification Date

May 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of California, San Diego

Investigator Full Name: Fatta B Nahab

Investigator Title: Associate Professor of Neurosciences

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: CBD/THC

Type: Experimental

Description: Treatment arm

Label: Placebo

Type: Placebo Comparator

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov