Actively Recruiting

Phase 2
Age: 40Years - 80Years
All Genders
NCT06629389

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

Led by Laboratorio Elea Phoenix S.A. · Updated on 2024-12-05

88

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants between 40 and 80 years old.
  • Diagnosed with Parkinson disease by clinical criteria with mild to moderate severity.
  • No changes to anti-Parkinson's medications for at least one month before study.
  • Willing and able to give informed consent.
  • Capable of understanding and agreeing to participate in the study.
Not Eligible

You will not qualify if you...

  • Evidence of dementia or Mini-Mental State Exam score below 24.
  • Severe psychiatric illness including severe depression or treatment-resistant psychosis.
  • History of hospitalization for mental health issues.
  • Known allergy to cannabinoids or any drug ingredients.
  • History of drug or alcohol dependence.
  • Use of dopamine blockers within 180 days before study.
  • Use of amphetamine inhibitors, cocaine, or MAO-A inhibitors within 90 days before study.
  • Recent use of specific interacting drugs including valproic acid, felbamate, niacin, nicotinamide, isoniazid, ketoconazole, or clobazam.
  • Unstable medical conditions indicated by low blood counts or high liver enzymes.
  • Moderate to severe liver disease (Child Pugh B-C).
  • Pregnant or breastfeeding women.
  • Women of childbearing potential not agreeing to effective contraception during and 4 weeks after study.
  • Previous surgical treatment for Parkinson disease.
  • New or recent diagnosis of Parkinson disease less than 5 years ago.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Español de Mendoza

Mendoza, Mendoza Province, Argentina, 5501

Actively Recruiting

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Research Team

M

Maria Daniela Di Leo, MD

CONTACT

M

Marcelo A Tinelli, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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