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Trial of Cannabis for Essential Tremor

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ClinicalTrials.gov Identifier: NCT03805750
Recruitment Status : Completed
First Posted : January 16, 2019
Results First Posted : October 13, 2022
Last Update Posted : October 13, 2022
Sponsor:
Collaborators:
International Essential Tremor Foundation
Tilray
Center for Medicinal Cannabis Research
Information provided by (Responsible Party):
Fatta B Nahab, 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.

Condition or disease Intervention/treatment Phase
Essential Tremor Drug: CBD/THC Drug: Placebo oral capsule Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Cross-Over, Placebo- Controlled Efficacy and Tolerability Study of Oral Cannabidiol (CBD) and Tetrahydrocannabinol (THC) for Essential Tremor (ET).
Actual Study Start Date : January 22, 2019
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : November 30, 2020


Arm Intervention/treatment
Experimental: CBD/THC
Treatment arm consisting of Tetrahydrocannabinol (5mg/capsule) and Cannabidiol (100mg/capsule).
Drug: CBD/THC
Oral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC).
Other Names:
  • marijuana
  • cannabis
  • cannabidiol
  • tetrahydrocannabinol

Placebo Comparator: Placebo
Matched placebo capsule with no active ingredients.
Drug: Placebo oral capsule
Matched Placebo




Primary Outcome Measures :
  1. Digital Spirography [ Time Frame: Day 22 (100 minutes post-dose) ]
    The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors.


Secondary Outcome Measures :
  1. Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS) [ Time Frame: Baseline and Day 22 ]
    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).

  2. Global Impression of Change [ Time Frame: Day 22 ]
    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'.

  3. Number of Participants Reporting Adverse Events Based on Common Terminology Criteria [ Time Frame: Days 1, 3, 6, 22 ]
    Side effects survey

  4. Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Day 22 ]
    This is a scale looking at risk assessment of suicidality. The presence of any positive responses will lead to further evaluation.

  5. Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities [ Time Frame: Day 22 ]
    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.

  6. Accelerometry-based Assessment of Tremor Severity [ Time Frame: Baseline and Day 22 ]
    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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805750


Locations
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United States, California
University of California San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
International Essential Tremor Foundation
Tilray
Center for Medicinal Cannabis Research
Investigators
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Principal Investigator: Fatta Nahab, MD UCSD
  Study Documents (Full-Text)

Documents provided by Fatta B Nahab, University of California, San Diego:
Additional Information:
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Responsible Party: Fatta B Nahab, Associate Professor of Neurosciences, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03805750    
Other Study ID Numbers: 180414
First Posted: January 16, 2019    Key Record Dates
Results First Posted: October 13, 2022
Last Update Posted: October 13, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Dronabinol
Cannabidiol
Anticonvulsants
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists