Trial of Cannabis for Essential Tremor
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|ClinicalTrials.gov Identifier: NCT03805750|
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : June 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Drug: CBD/THC Drug: Placebo oral capsule||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 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|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
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).
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
|Contact: Len Lazarofirstname.lastname@example.org|
|United States, California|
|University of California San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Len Lazaro 858-822-3708 email@example.com|
|Principal Investigator: Fatta Nahab, MD|
|Principal Investigator:||Fatta Nahab, MD||UCSD|