Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms

Официальное название

Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate Safety and Tolerability of Cannabidiol (Kanbis®) for the Treatment of Parkinson's Disease Symptoms

Обзор

Parkinson disease (PD) is a chronic, progressive neurodegenerative disorder characterized by clinical motor and non-motor symptoms. Knowing the potential benefits has led to the use of cannabis as an alternative therapy.

Подробное описание

To evaluate safety and tolerability of CBD-based drug product at different doses

Вмешательства

• Препарат Cannabidiol 100 mg/ml
  The following dose regime for the 4 treatment arms will be used: DOSE TITRATION PERIOD: First 5 days: 0.3 mL/day (1 dose) Subsequent 5 days: 0.6 mL/day (2 doses of 0.3 mL/dose) Subsequent 5 days: 0.8 mL/day (2 doses of 0.4 mL/dose) Last 5 days: 1 mL/day (2 doses of 0.4 mL/dose) PERIOD OF ACTIVE TREATMENT Continue with the last dose set by the titration schedule (for 12 weeks). PERIOD OF TREATMENT INTERRUPTION Medication is gradually discontinued every 7 days until complete termination. The fir
• Препарат cannabidiol 300 mg/ml
  The following dose regime for the 4 treatment arms will be used: DOSE TITRATION PERIOD: First 5 days: 0.3 mL/day (1 dose) Subsequent 5 days: 0.6 mL/day (2 doses of 0.3 mL/dose) Subsequent 5 days: 0.8 mL/day (2 doses of 0.4 mL/dose) Last 5 days: 1 mL/day (2 doses of 0.4 mL/dose) PERIOD OF ACTIVE TREATMENT Continue with the last dose set by the titration schedule (for 12 weeks). PERIOD OF TREATMENT INTERRUPTION Medication is gradually discontinued every 7 days until complete termination. The fir
• Препарат Cannabidiol 400 mg/ml
  The following dose regime for the 4 treatment arms will be used: DOSE TITRATION PERIOD: First 5 days: 0.3 mL/day (1 dose) Subsequent 5 days: 0.6 mL/day (2 doses of 0.3 mL/dose) Subsequent 5 days: 0.8 mL/day (2 doses of 0.4 mL/dose) Last 5 days: 1 mL/day (2 doses of 0.4 mL/dose) PERIOD OF ACTIVE TREATMENT Continue with the last dose set by the titration schedule (for 12 weeks). PERIOD OF TREATMENT INTERRUPTION Medication is gradually discontinued every 7 days until complete termination. The fir
• Препарат Placebo
  The following dose regime for the 4 treatment arms will be used: DOSE TITRATION PERIOD: First 5 days: 0.3 mL/day (1 dose) Subsequent 5 days: 0.6 mL/day (2 doses of 0.3 mL/dose) Subsequent 5 days: 0.8 mL/day (2 doses of 0.4 mL/dose) Last 5 days: 1 mL/day (2 doses of 0.4 mL/dose) PERIOD OF ACTIVE TREATMENT Continue with the last dose set by the titration schedule (for 12 weeks). PERIOD OF TREATMENT INTERRUPTION Medication is gradually discontinued every 7 days until complete termination. The fir

Первичные конечные точки

• Number of patients with advers events related to treatment acording to CTCAE v5.0 [Срок оценки: up to 21 weeks]

Вторичные конечные точки (10)

• Changes in differents motors scales in Parkinson desease [Срок оценки: up to 15 weeks]
• Changes in the off periods in Parkinson desease [Срок оценки: up to 15 weeks]
• Changes in the patients Clinical Global Impression in Parkinson desease [Срок оценки: up to 21 weeks]
• Changes in the quality-of-life in Parkinson desease [Срок оценки: up to 15 weeks]
• Changes in differents no motors symproms in Parkinson desease [Срок оценки: up to 15 weeks]
• Changes in depression in Parkinson desease [Срок оценки: up to 15 weeks]
• Changes in sleep in Parkinson disease [Срок оценки: up to 15 weeks]
• Changes in Cognitive Assessment in Parkinson desease [Срок оценки: up to 15 weeks]
• Changes in apathy in Parkinson desease [Срок оценки: up to 15 weeks]
• Changes in pain in Parkinson desease [Срок оценки: up to 15 weeks]

Критерии участия

Критерии включения

• Participants between 40 and 80 years old.
• Participants diagnosed with PD according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson\'s disease (72), and to the Brain Bank Criteria for Parkinson\'s disease, with mild to moderate disease as measured by the modified Hoehn and Yahr scale. (Both clinical criteria are included since many of the study participants were diagnosed with previous criteria and others with current criteria, both of which are very similar and do not change or raise any doubt about the diagnosis of the disease).
• Participants who have not changed their anti-Parkinson's drugs (or dose) at least one month prior to study entry.
• Acceptance by the participant by signing the ICF.
• Subjects capable of giving consent to participate in the study

Критерии исключения

• Evidence of dementia, Mini-Mental State Exam score less than 24 or with previous diagnosis by cognitive assessment .
• Severe psychiatric pathology: severe depression, treatment-refractory psychosis. Evaluation by psychiatrist who confirms the pathology. History of hospitalization in a psychiatric center or mental health center is an exclusion criterion regardless of the time spent since hospitalization or the reason for which the patient was hospitalized.
• Known or suspected allergy to cannabinoids or inactive ingredients used in the formulation of the study drug.
• History of drug or alcohol dependence.
• Use of dopamine blockers within 180 days prior to study entry.
• Use of amphetamine inhibitors, cocaine and MAO-A inhibitors within 90 days prior to study entry.
• Patients who have received within 90 days prior to study entry the following drugs due to drug interactions: valproic acid, felbamate, niacin (nicotinic acid) at doses ≥2000mg/day or nicotinamide (nicotinic acid amide or nicotinamide) at doses ≥3000mg/day, isoniazid, ketoconazole and/or clobazam.
• Unstable medical condition detected by the following laboratory alterations: Hemoglobin\<10g/dL, Leukocytes\<4000 u/ml, Neutrophils\<1500 u/ml, Lymphocytes\<500u/ml, Platelets\<100000 u/ml, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\> 3 times the upper limit of normal.
• Moderate-severe liver disease. (Child Pugh B-C)
• Pregnant or breastfeeding.
• Women of reproductive age who do not agree to use at least one contraceptive method of proven efficacy (diaphragm or partner using condom, oral or implanted hormonal contraceptive; intrauterine device, stable partner with vasectomy), until at least four weeks after completion of study treatment. Pregnancy blood test will be performed before starting the study.
• Participants who have had a surgical procedure for PD, either deep brain stimulation or surgery for lesion.
• Patients de novo or with recent diagnosis of PD (less than 5 years).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Аргентина · 1 центр

• Hospital Español de Mendoza — Mendoza

Идентификаторы

NCT: NCT06629389 · CBD-EP-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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