Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| International Essential Tremor Foundation | OTHER |
| Tilray | INDUSTRY |
| Center for Medicinal Cannabis Research | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Essential tremor (ET) is the most common neurological movement disorder, affecting up to 1% of the population and up to 5% of individuals over the age of 65. ET is characterized by often disabling tremors that occur when an individual moves. The tremors most commonly affect the hands, head, voice, and legs in order of frequency, leading to impairment in activities of daily living and morbidity. No pharmacological agent has been developed for ET, though existing agents such as propranolol and primidone are used off-label to reduce tremor amplitude. Deep brain stimulation surgery is often reserved for only individuals with the most severe tremors. Patients with ET have long reported tremor benefits with the use of cannabis, though no controlled trials have been conducted. The investigators plan to conduct the first double-blind, placebo-control clinical trial of cannabis in an oral capsule. Various validated tremor rating methods will be used to quantify tremor severity, while looking at tolerability and safety.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBD/THC | Experimental | Treatment arm consisting of Tetrahydrocannabinol (5mg/capsule) and Cannabidiol (100mg/capsule). |
|
| Placebo | Placebo Comparator | Matched placebo capsule with no active ingredients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD/THC | Drug | Oral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Digital Spirography | The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors. | Day 22 (100 minutes post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS) | 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). | Baseline and Day 22 |
| Global Impression of Change |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fatta Nahab, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | United States |
Not provided
| Label | URL |
|---|---|
| Study Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a cross-over design where each subject receives both a placebo and treatment arm in blinded random order.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CBD/THC First Then Placebo | After randomization, each patient will receive study medication in two study periods. Each study period includes 1-week titration, 2-week treatment, and 1-week tapering. There is a 3-week washout period between the two study periods. During the titration period, patients will have a starting dose of 1 capsule (placebo or 5mg THC/100mg CBD) per day; 2 capsules per day on day 3; 3 capsules per day on day 6. If the patient or investigator feel that the higher study drug dose of 3 caps per day is causing troublesome side effects, the dosage may be lowered to 2 caps per day. Patients will continue on this target dose during the 2-week treatment and then gradually taper from medication over one week. Patients will crossover to the alternate treatment after a 3-week washout period. |
| FG001 | Placebo First Then CBD/THC | After randomization, each patient will receive study medication in two study periods. Each study period includes 1-week titration, 2-week treatment, and 1-week tapering. There is a 3-week washout period between the two study periods. During the titration period, patients will have a starting dose of 1 capsule (placebo or 5mg THC/100mg CBD) per day; 2 capsules per day on day 3; 3 capsules per day on day 6. If the patient or investigator feel that the higher study drug dose of 3 caps per day is causing troublesome side effects, the dosage may be lowered to 2 caps per day. Patients will continue on this target dose during the 2-week treatment and then gradually taper from medication over one week. Patients will crossover to the alternate treatment after a 3-week washout period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention - 4 Weeks |
| |||||||||||||
| Second Intervention - 4 Weeks |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | After randomization, each patient will receive study medication in two study periods. Each study period includes 1-week titration, 2-week treatment, and 1-week tapering. There is a 3-week washout period between the two study periods. During the titration period, patients will have a starting dose of 1 capsule (placebo or 5mg THC/100mg CBD) per day; 2 capsules per day on day 3; 3 capsules per day on day 6. If the patient or investigator feel that the higher study drug dose of 3 caps per day is causing troublesome side effects, the dosage may be lowered to 2 caps per day. Patients will continue on this target dose during the 2-week treatment and then gradually taper from medication over one week. Patients will crossover to the alternate treatment after a 3-week washout period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Digital Spirography | The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors. | Posted | Mean | Standard Deviation | millimeters of tremor amplitude | Day 22 (100 minutes post-dose) |
|
|
Over the course of the study period (77 days).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBD/THC | Treatment arm CBD/THC: Oral formulation of CBD and THC. | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ringing in ears | Ear and labyrinth disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| F.B. Nahab MD | University of California San Diego | 858-822-6683 | fnahab@health.ucsd.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2013 | Oct 9, 2022 | Prot_SAP_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C587251 | nabiximols |
| D002185 | Cannabidiol |
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo oral capsule | Drug | Matched Placebo |
|
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'. |
| Day 22 |
| Number of Participants Reporting Adverse Events Based on Common Terminology Criteria | Side effects survey | Days 1, 3, 6, 22 |
| Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS) | This is a scale looking at risk assessment of suicidality. The presence of any positive responses will lead to further evaluation. | Day 22 |
| Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities | 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. | Day 22 |
| Accelerometry-based Assessment of Tremor Severity | 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. | Baseline and Day 22 |
| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS) | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 22 |
|
|
|
| Secondary | Global Impression of Change | 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'. | Posted | Mean | Full Range | score on a scale | Day 22 |
|
|
|
| Secondary | Number of Participants Reporting Adverse Events Based on Common Terminology Criteria | Side effects survey | Posted | Count of Participants | Participants | Days 1, 3, 6, 22 |
|
|
|
| Secondary | Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS) | This is a scale looking at risk assessment of suicidality. The presence of any positive responses will lead to further evaluation. | Posted | Count of Participants | Participants | Day 22 |
|
|
|
| Secondary | Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities | 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. | Posted | Count of Participants | Participants | Day 22 |
|
|
|
|
| Secondary | Accelerometry-based Assessment of Tremor Severity | 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. | Participants in both treatment arms will undergone tremor measurement using accelerometry as a surrogate of tremor severity. | Posted | Mean | Standard Deviation | Proportion of baseline spectral power | Baseline and Day 22 |
|
|
|
| 7 |
| 0 |
| 7 |
| 7 |
| 7 |
| EG001 | Placebo | Placebo oral capsule: Placebo | 0 | 7 | 0 | 7 | 6 | 7 |
| Numbness/tingling | Nervous system disorders | Systematic Assessment |
|
| Dyspnea on exertion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Watery eyes | Eye disorders | Systematic Assessment |
|
| Runny nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Decreased concentration | Nervous system disorders | Systematic Assessment |
|
| Sleepiness | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
|
| Increased sleepiness | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Memory problems | Nervous system disorders | Systematic Assessment |
|
| Imbalance | Nervous system disorders | Systematic Assessment |
|
| Mild headache | Nervous system disorders | Systematic Assessment |
|
| Grogginess/cognitive slowing | Nervous system disorders | Systematic Assessment |
|
| Tiredness | Nervous system disorders | Systematic Assessment |
|
| Thumb pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Lightheadedness | Cardiac disorders | Systematic Assessment |
|
| Feeling high/intoxication | Nervous system disorders | Systematic Assessment |
|
| Decreased libido | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Euphoria | Psychiatric disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Feeling relaxed | General disorders | Systematic Assessment |
|
| Increased thirst | Gastrointestinal disorders | Systematic Assessment |
|
| Felt buzzed | Nervous system disorders | Systematic Assessment |
|
| Quivering voice | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Visual slowing | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
| Dyspnea on exertion |
|
| Watery eyes |
|
| Runny nose |
|
| Decreased concentration |
|
| Sleepiness |
|
| Insomnia |
|
| Increased sleepiness |
|
| Dizziness |
|
| Memory problems |
|
| Imbalance |
|
| Mild headache |
|
| Groggy |
|
| Tired |
|
| Thumb pain |
|
| Anxiety |
|
| Headache |
|
| Lightheaded |
|
| Felt high |
|
| Decreased libido |
|
| Diarrhea |
|
| Dry mouth |
|
| Euphoria |
|
| Fatigue |
|
| Feels relaxed |
|
| Increased thirst |
|
| Felt buzzed |
|
| Quivering voice |
|
| Visual slowing |
|