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Trial of Cannabis for Essential Tremor

Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
Statusİşə qəbul
Sponsorlar
University of California, San Diego
Əməkdaşlar
International Essential Tremor Foundation
Tilray
Center for Medicinal Cannabis Research

Açar sözlər

Mücərrəd

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.

Təsvir

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.

Tarixlər

Son Doğrulandı: 04/30/2020
İlk təqdim: 01/08/2019
Təxmini qeydiyyat təqdim edildi: 01/10/2019
İlk Göndərmə: 01/15/2019
Son Yeniləmə Göndərildi: 05/26/2020
Son Yeniləmə Göndərildi: 05/28/2020
Həqiqi Təhsilin Başlama Tarixi: 01/21/2019
Təxmini İlkin Tamamlanma Tarixi: 08/31/2020
Təxmini İşin Tamamlanma Tarixi: 11/30/2020

Vəziyyət və ya xəstəlik

Essential Tremor

Müdaxilə / müalicə

Drug: CBD/THC

Drug: Placebo

Faza

Faza 1/Faza 2

Qol Qrupları

QolMüdaxilə / müalicə
Experimental: CBD/THC
Treatment arm
Drug: CBD/THC
Oral formulation of CBD and THC.
Placebo Comparator: Placebo
Drug: Placebo
Placebo

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar 21 Years Üçün 21 Years
Təhsilə Uyğun CinslərAll
Sağlam Könüllüləri qəbul edirBəli
Kriteriyalar

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)

Nəticə

İlkin nəticə tədbirləri

1. Digital spirography [Day 22]

The tremor amplitude calculated using computerized spirography to measure kinetic tremors.

İkincili Nəticə Tədbirləri

1. Tremor Research Group Essential Tremor Rating Scale (TETRAS) [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).

2. Global Impression of Change [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'.

3. Common Terminology Criteria for Adverse Events [Days 1, 3, 6, 22]

Side effects survey

4. Columbia-Suicide Severity Rating Scale (C-SSRS) [Day 22]

This is a scale looking at risk assessment of suicidality. The presence of any positive responses will lead to further evaluation.

5. EKG [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.

6. Accelerometry [Day 22]

The spectral power density will serve as a measures of tremor severity relative to baseline tremor power (no units).

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Bir simptom və ya bir xəstəlik yazın və kömək edə biləcək otlar haqqında oxuyun, bir ot yazın və istifadə olunan xəstəliklərə və simptomlara baxın.
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