NCT06629389

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2 parkinson-disease

Timeline
5mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Nov 2024Nov 2026

First Submitted

Initial submission to the registry

September 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

December 5, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 30, 2024

Last Update Submit

December 3, 2024

Conditions

Parkinson Disease

Keywords

parkinson diseaseCannabidioloilcannabis

Outcome Measures

Primary Outcomes (1)

  • Number of patients with advers events related to treatment acording to CTCAE v5.0

    Frequency of adverse events by a global comparison of all dose or placebo groups Range: 1 to 5 Higher values represent a worse disease state

    up to 21 weeks

Secondary Outcomes (10)

  • Changes in differents motors scales in Parkinson desease

    up to 15 weeks

  • Changes in the off periods in Parkinson desease

    up to 15 weeks

  • Changes in the patients Clinical Global Impression in Parkinson desease

    up to 21 weeks

  • Changes in the quality-of-life in Parkinson desease

    up to 15 weeks

  • Changes in differents no motors symproms in Parkinson desease

    up to 15 weeks

  • +5 more secondary outcomes

Study Arms (4)

Group CBD 100

ACTIVE COMPARATOR

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

Drug: Cannabidiol 100 mg/ml

Group CBD 300

ACTIVE COMPARATOR

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

Drug: cannabidiol 300 mg/ml

Group CBD 400

ACTIVE COMPARATOR

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

Drug: Cannabidiol 100 mg/mlDrug: Cannabidiol 400 mg/ml

Group Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cannabidiol 100 mg/mlDRUG

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.

Also known as: CBD, Cannabis
Group CBD 100Group CBD 400
cannabidiol 300 mg/mlDRUG

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
Cannabidiol 400 mg/mlDRUG

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
PlaceboDRUG

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

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Español de Mendoza

Mendoza, Mendoza Province, 5501, Argentina

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseMarijuana Abuse

Interventions

Cannabidiolnabiximols

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Marina Sanchez Abraham, Neurologa

    Hospital Español de Mendoza

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Daniela Di Leo, MD

CONTACT

1144898300daniela.dileo@elea.com

Marcelo A Tinelli, MD

CONTACT

1144898300marcelo.tinelli@elea.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, placebo-controlled
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2024

First Posted

October 8, 2024

Study Start

November 28, 2024

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

December 5, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)