Phase 2
N=7
Trial of Cannabis for Essential Tremor
Essential Tremor
Bottom Line
View on ClinicalTrials.gov: NCT03805750 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Digital Spirography — 1.04; 1.00 millimeters of tremor amplitude
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CBD/THC (Drug); Placebo oral capsule (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Digital Spirography |
1.04; 1.00 | — |
| SECONDARY Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS) |
-8.07; -10.3 | — |
| SECONDARY Global Impression of Change |
3; 4; 3; 4 | — |
| SECONDARY Number of Participants Reporting Adverse Events Based on Common Terminology Criteria |
7; 6; 4; 4; 4; 4 | — |
| SECONDARY Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS) |
0; 0 | — |
| SECONDARY Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities |
0; 0 | 0.52 |
| SECONDARY Accelerometry-based Assessment of Tremor Severity |
0.012; 0.007 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03805750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.