Trial of Cannabis for Essential Tremor
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|ClinicalTrials.gov Identifier: NCT03805750|
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : December 21, 2020
|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|
Oral formulation of CBD and THC.
|Placebo Comparator: Placebo||
Drug: Placebo oral capsule
- Digital spirography [ Time Frame: Day 22 ]The tremor amplitude calculated using computerized spirography to measure kinetic tremors.
- Tremor Research Group Essential Tremor Rating Scale (TETRAS) [ Time Frame: 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'.
- Common Terminology Criteria for Adverse Events [ Time Frame: Days 1, 3, 6, 22 ]Side effects survey
- 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.
- EKG [ Time Frame: Day 22 ]Electrocardiographic changes from baseline measures will trigger further evaluation. EKG's will be rated as normal/abnormal, and clinically significant/not clinically significant.
- Accelerometry [ Time Frame: Day 22 ]The spectral power density will serve as a measures of tremor severity relative to baseline tremor power (no units).
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|