Parkinson DiseasePhase 2CBD-EP-2NCT06629389
Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms
A Phase 2 study testing Cannabidiol 100 mg/ml, cannabidiol 300 mg/ml and Cannabidiol 400 mg/ml in people with Parkinson Disease, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cannabidiol 100 mg/ml, cannabidiol 300 mg/ml and Cannabidiol 400 mg/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteArgentina
- Study dates
- 28 Nov 2024to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Español de Mendoza
Mendoza, Mendoza Province, 5501
Marina Sanchez Abraham, Neurologa, 0261 449-0300, marinasanchezabraham@gmail.com
Marina Sanchez Abraham, Neurologa
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate Safety and Tolerability of Cannabidiol (Kanbis®) for the Treatment of Parkinson&#39;s Disease Symptoms
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.
Read the detailed description
To evaluate safety and tolerability of CBD-based drug product at different doses
- Conditions
- Parkinson Disease
- Being tested
- Cannabidiol 100 mg/ml, cannabidiol 300 mg/ml, Cannabidiol 400 mg/ml, Placebo
- Keywords
- parkinson disease, Cannabidiol, oil, cannabis
- Medical subject headings
- Parkinson Disease, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol 100 mg/mlDrug
Also called CBD, Cannabis
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 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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group CBD 100 | Active comparator | The following dose regime for the 4 treatment arms will be used Receives: Drug: Cannabidiol 100 mg/ml |
| Group CBD 300 | Active comparator | The following dose regime for the 4 treatment arms will be used Receives: Drug: cannabidiol 300 mg/ml |
| Group CBD 400 | Active comparator | The following dose regime for the 4 treatment arms will be used Receives: Drug: Cannabidiol 100 mg/ml; Drug: Cannabidiol 400 mg/ml |
| Group Placebo | Placebo comparator | The following dose regime for the 4 treatment arms will be used Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 21 weeks
Secondary outcomes (10)
Changes in differents motors scales in Parkinson desease
changes in the Unified Parkinson's Disease Rating Scale scale (MDS-UPDRS) part I (mental section), part II (daily activities), part III, (motor section), and part IV (treatment complications).
Overall range (Part I+II+III+IV): 0 to 260 Higher values represent a worse disease state
Measured: up to 15 weeks
Changes in the off periods in Parkinson desease
- variations in the off periods using the patient's personal diary
Measured: up to 15 weeks
Changes in the patients Clinical Global Impression in Parkinson desease
- changes in the patients Clinical Global Impression as measured by the Clinical Global Impression-Severity Scale (CGI-S).
Range: 0 to 7 Higher values represent a worse disease state
Measured: up to 21 weeks
Changes in the quality-of-life in Parkinson desease
- changes in the quality-of-life scale with the Parkinson's Disease Questionnaire (PDQ39).
Range: 0 to 100 Higher values represent a worse disease state
Measured: up to 15 weeks
Changes in differents no motors symproms in Parkinson desease
- changes in non-motor symptoms by means of Non-Motor Symptom Scale (NMSS) and Non-Motor Symptoms Questionnaire (NMSQ).
Measured: up to 15 weeks
Changes in depression in Parkinson desease
- changes in depression with the Beck Depression Inventory Scale (BDI-II). Overall range: 0 to 63. Higher values represent a worse disease state
Measured: up to 15 weeks
Changes in sleep in Parkinson disease
- changes in the sleep scale for Parkinson Desease with Epworth Scale. Overall range: 0 to 24. Higher values represent a worse disease state
Measured: up to 15 weeks
Changes in Cognitive Assessment in Parkinson desease
To assess the Montreal Cognitive Assessment (MoCA) scale Maximum score 30 Score greater than 26 is considered normal
Measured: up to 15 weeks
Changes in apathy in Parkinson desease
- changes in apathy measured by the Apathy Evaluation Scale (AES). Total score ranges: 18 to 72 Higher scores indicating more apathy
Measured: up to 15 weeks
Changes in pain in Parkinson desease
- DP pain-related changes measured by the King's Parkinson's Disease Pain Scale (KPSS).
Range: 0 to 168 Higher values represent a worse disease state
Measured: up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start28 Nov 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorio Elea Phoenix S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marina Sanchez Abraham, Neurologa, Principal investigator, Hospital Español de Mendoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629389
- Sponsor's protocol ID
- CBD-EP-2
- Acronym
- CBD-EP-2
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate Safety and Tolerability of Cannabidiol (Kanbis®) for the Treatment of Parkinson&#39;s Disease Symptoms
- ClinicalTrials.gov ID
- NCT06629389
- Acronym / sponsor ID
- CBD-EP-2 / CBD-EP-2
- Conditions
- Parkinson Disease
- Keywords
- parkinson disease, Cannabidiol, oil, cannabis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Laboratorio Elea Phoenix S.A.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Group CBD 100 | Active comparator | Drug: Cannabidiol 100 mg/mlThe following dose regime for the 4 treatment arms will be used |
| Group CBD 300 | Active comparator | Drug: cannabidiol 300 mg/mlThe following dose regime for the 4 treatment arms will be used |
| Group CBD 400 | Active comparator | Drug: Cannabidiol 100 mg/ml, Drug: Cannabidiol 400 mg/mlThe following dose regime for the 4 treatment arms will be used |
| Group Placebo | Placebo comparator | Drug: PlaceboThe following dose regime for the 4 treatment arms will be used |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol 100 mg/mlAlso: CBD, CannabisThe 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. | Drug | Group CBD 100, Group CBD 400 |
| cannabidiol 300 mg/mlThe 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. | Drug | Group CBD 300 |
| Cannabidiol 400 mg/mlThe 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. | Drug | Group CBD 400 |
| PlaceboThe 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. | Drug | Group Placebo |
Primary outcome
Number of patients with advers events related to treatment acording to CTCAE v5.0
Time frame: up to 21 weeks
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
10 secondary outcomes
Changes in differents motors scales in Parkinson desease
Time frame: up to 15 weeks
Changes in the off periods in Parkinson desease
Time frame: up to 15 weeks
Changes in the patients Clinical Global Impression in Parkinson desease
Time frame: up to 21 weeks
Changes in the quality-of-life in Parkinson desease
Time frame: up to 15 weeks
Changes in differents no motors symproms in Parkinson desease
Time frame: up to 15 weeks
Changes in depression in Parkinson desease
Time frame: up to 15 weeks
Changes in sleep in Parkinson disease
Time frame: up to 15 weeks
Changes in Cognitive Assessment in Parkinson desease
Time frame: up to 15 weeks
Changes in apathy in Parkinson desease
Time frame: up to 15 weeks
Changes in pain in Parkinson desease
Time frame: up to 15 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marina Sanchez Abraham, Neurologa principal investigator
Hospital Español de Mendoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol 100 mg/ml, cannabidiol 300 mg/ml and Cannabidiol 400 mg/ml in people with Parkinson Disease, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Daniela Di Leo, MD (1144898300, daniela.dileo@elea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with advers events related to treatment acording to CTCAE v5.0 (time frame: up to 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.