NCT03805750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

January 22, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 13, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

January 9, 2019

Results QC Date

February 15, 2022

Last Update Submit

October 9, 2022

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

  • Digital Spirography

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

    Day 22 (100 minutes post-dose)

Secondary Outcomes (6)

  • Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS)

    Baseline and Day 22

  • Global Impression of Change

    Day 22

  • Number of Participants Reporting Adverse Events Based on Common Terminology Criteria

    Days 1, 3, 6, 22

  • Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS)

    Day 22

  • Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities

    Day 22

  • +1 more secondary outcomes

Study Arms (2)

CBD/THC

EXPERIMENTAL

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

Drug: CBD/THC

Placebo

PLACEBO COMPARATOR

Matched placebo capsule with no active ingredients.

Drug: Placebo oral capsule

Interventions

CBD/THCDRUG

Oral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC).

Also known as: marijuana, cannabis, cannabidiol, tetrahydrocannabinol
CBD/THC
Placebo oral capsuleDRUG

Matched Placebo

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

Related Links

MeSH Terms

Conditions

Essential Tremor

Interventions

nabiximolsCannabidiolDronabinol

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
F.B. Nahab MD
Organization
University of California San Diego
fnahab@health.ucsd.edu
858-822-6683

Study Officials

  • Fatta Nahab, MD

    UCSD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurosciences

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 16, 2019

Study Start

January 22, 2019

Primary Completion

September 1, 2020

Study Completion

November 30, 2020

Last Updated

October 13, 2022

Results First Posted

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)