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

NCT ID: NCT06629389

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-28
• Study Completion Date: 2026-11-30

Brief Summary

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.

Detailed Description

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

Conditions

Parkinson Disease

Keywords

parkinson disease; Cannabidiol; oil; cannabis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group CBD 100

The following dose regime for the 4 treatment arms will be used

Group Type: ACTIVE_COMPARATOR

Cannabidiol 100 mg/ml

Intervention Type: DRUG

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 first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.

Group CBD 300

The following dose regime for the 4 treatment arms will be used

Group Type: ACTIVE_COMPARATOR

cannabidiol 300 mg/ml

Intervention Type: DRUG

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 first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.

Group CBD 400

The following dose regime for the 4 treatment arms will be used

Group Type: ACTIVE_COMPARATOR

Cannabidiol 100 mg/ml

Intervention Type: DRUG

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 first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.

Cannabidiol 400 mg/ml

Intervention Type: DRUG

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 first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.

Group Placebo

The following dose regime for the 4 treatment arms will be used

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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 first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.

Interventions

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 first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.

Intervention Type: DRUG

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 first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.

Intervention Type: DRUG

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 first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.

Intervention Type: DRUG

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 first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.

Intervention Type: DRUG

Other Intervention Names

CBD; Cannabis

Eligibility Criteria

Inclusion Criteria

1. Participants between 40 and 80 years old.

2. 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).

3. Participants who have not changed their anti-Parkinson's drugs (or dose) at least one month prior to study entry.

4. Acceptance by the participant by signing the ICF.

5. Subjects capable of giving consent to participate in the study

Exclusion Criteria

1. Evidence of dementia, Mini-Mental State Exam score less than 24 or with previous diagnosis by cognitive assessment .

2. 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.

3. Known or suspected allergy to cannabinoids or inactive ingredients used in the formulation of the study drug.

4. History of drug or alcohol dependence.

5. Use of dopamine blockers within 180 days prior to study entry.

6. Use of amphetamine inhibitors, cocaine and MAO-A inhibitors within 90 days prior to study entry.

7. 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.

8. 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.

9. Moderate-severe liver disease. (Child Pugh B-C)

10. Pregnant or breastfeeding.

11. 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.

12. Participants who have had a surgical procedure for PD, either deep brain stimulation or surgery for lesion.

13. Patients de novo or with recent diagnosis of PD (less than 5 years).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorio Elea Phoenix S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina Sanchez Abraham, Neurologa

Role: PRINCIPAL_INVESTIGATOR

Hospital Español de Mendoza

Locations

Hospital Español de Mendoza

Mendoza, Mendoza Province, Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Maria Daniela Di Leo, MD

Role: CONTACT

Phone: 1144898300

Email: daniela.dileo@elea.com

Marcelo A Tinelli, MD

Role: CONTACT

Phone: 1144898300

Email: marcelo.tinelli@elea.com

Facility Contacts

Marina Sanchez Abraham, Neurologa

Role: primary

Marina Sanchez Abraham, Neurologa

Role: backup

Other Identifiers

CBD-EP-2

Identifier Type: -

Identifier Source: org_study_id