Trial of Cannabis for Essential Tremor
Paraules clau
Resum
Descripció
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.
Dates
| Darrera verificació: | 04/30/2020 |
| Primer enviat: | 01/08/2019 |
| Inscripció estimada enviada: | 01/10/2019 |
| Publicat per primera vegada: | 01/15/2019 |
| Última actualització enviada: | 05/26/2020 |
| Publicació de l'última actualització: | 05/28/2020 |
| Data d'inici de l'estudi real: | 01/21/2019 |
| Data estimada de finalització primària: | 08/31/2020 |
| Data estimada de finalització de l’estudi: | 11/30/2020 |
Condició o malaltia
Intervenció / tractament
Drug: CBD/THC
Drug: Placebo
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: CBD/THC Treatment arm | Drug: CBD/THC Oral formulation of CBD and THC. |
| Placebo Comparator: Placebo | Drug: Placebo Placebo |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 21 Years Per a 21 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | 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) |
Resultat
Mesures de resultats primaris
1. Digital spirography [Day 22]
Mesures de resultats secundaris
1. Tremor Research Group Essential Tremor Rating Scale (TETRAS) [Day 22]
2. Global Impression of Change [Day 22]
3. Common Terminology Criteria for Adverse Events [Days 1, 3, 6, 22]
4. Columbia-Suicide Severity Rating Scale (C-SSRS) [Day 22]
5. EKG [Day 22]
6. Accelerometry [Day 22]
