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
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Drug: CBD/THC Drug: Placebo oral capsule||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Treatment arm consisting of Tetrahydrocannabinol (5mg/capsule) and Cannabidiol (100mg/capsule).
Oral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC).
Placebo Comparator: Placebo
Matched placebo capsule with no active ingredients.
Drug: Placebo oral capsule
- Digital Spirography [ Time Frame: Day 22 (100 minutes post-dose) ]The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors.
- 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).
- 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'.
- Number of Participants Reporting Adverse Events Based on Common Terminology Criteria [ Time Frame: Days 1, 3, 6, 22 ]Side effects survey
- 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.
- 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.
- 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.
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
|United States, California|
|University of California San Diego|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Fatta Nahab, MD||UCSD|