Clinical trial NCT03805750: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Essential Tremor
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: International Essential Tremor Foundation
name: Tilray
name: Center for Medicinal Cannabis Research
First posted: 2019-01-16
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Digital Spirography
timeFrame: Day 22 (100 minutes post-dose)
Secondary outcomes:
measure: Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS)
timeFrame: Baseline and Day 22
measure: Global Impression of Change
timeFrame: Day 22
measure: Number of Participants Reporting Adverse Events Based on Common Terminology Criteria
timeFrame: Days 1, 3, 6, 22
measure: Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Day 22
measure: Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities
timeFrame: Day 22
measure: Accelerometry-based Assessment of Tremor Severity
timeFrame: Baseline and Day 22
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: UCSD
name: Fatta Nahab, MD
role: PRINCIPAL_INVESTIGATOR
References: