A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease

NCT03582137 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 17-2318
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The major purpose of this study is to assess the efficacy of CBD on motor symptoms of Parkinson's Disease (PD), and secondarily to study the safety and tolerability of CBD and other efficacy, particularly regarding tremor in PD. The study has been powered to detect a clinically significant reduction in Movement Disorder Society (MDS) Unified Parkinson's Disease Rating Scale (UPDRS) Part III motor scores. This is a 1:1 parallel, double-blind, randomized controlled trial (RCT) with 60 participants. The investigators will be recruiting up to 75 participants; the goal is to have 60 participants (30 in CBD group and 30 in placebo group) complete the study. The study drug is obtained from the National Institute on Drug Abuse (NIDA).

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Motor symptoms; Tremor; tolerability; safety; cognition; anxiety; psychosis; mood; dyskinesia; sleep; cannabidiol; cannabis; efficacy; non-motor symptoms; quality of life; seborrhea

Outcome Measures

Primary Outcomes (1)

• Change in Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) Scores

  Movement Disorders Society-Unified Parkinson's disease rating scale(MDS UPDRS) Part III assesses the motor signs of PD. There are 33 scores based on 18 items, several with right, left or other body distribution scores.Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. The possible change may be the scores of the total 33 scores. Scores ranges 0 -132. Higher values represent a worse outcome.

  From baseline to the end of 2.5 mg/kg/day of CBD, through 3 weeks

Secondary Outcomes (60)

• The Number of Participants Wtih Treatment-related Adverse Events

  Every 3-5 days at each dose level, assessed up to 3 weeks

• Change in Liver Function Monitoring --Liver Function Test

  Baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks.

• The Number of Participants Wtih Liver Function Impairment Related Adverse Events

  Baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks.

• Change in Blood Pressure (Systolic)

  Baseline; at the end of 2.5 mg/kg/day, through 3 weeks

• Change in Vital Signs-heart Rate

  Baseline; at the end of 2.5 mg/kg/day, through 3 weeks

Study Arms (2)

CBD Cannabis extract oral solution

EXPERIMENTAL

Cannabidiol (CBD) Cannabis extract oral solution

Drug: Cannabidiol

placebo

PLACEBO COMPARATOR

Placebo oral solution

Other: Placebo

Interventions

Cannabidiol DRUG

Subjects randomized to this arm will receive Cannabidiol Cannabis extract oral solution

Also known as: CBD

CBD Cannabis extract oral solution

Placebo OTHER

Subjects randomized to this arm will receive Placebo

placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants 40 - 85 years of age.
• Willing and able to give informed consent (including through use of a legally authorized representative (LAR), if necessary).
• Idiopathic PD, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
• ON motor MDS UPDRS \>20.
• Anti-parkinsonian medication is fixed for at least one month prior to the day the participant starts study drug treatment.
• If MoCA\<22 participant must have a designated caregiver that agrees to ensure study protocols followed. This includes accompanying patient to study visits and being available for study phone calls.
• Must have a driver or available transportation (including provided Uber vouchers) to drive them to and from study visits and for other transportation needs during the treatment period.
• Has a significant other (someone who knows the participant well) that is appropriate for doing the NPI assessment, and agrees to do so
• Agrees to not take more than 1 gram per day of acetaminophen, due to a possible interaction with study drug that could increase risk of hepatotoxicity.

You may not qualify if:

• Known or suspected allergy to cannabinoids or excipients used in the study drug formulation.
• Cannabis is detectable at the screening visit by blood testing or at the baseline visit by urine testing. If cannabis is detected at either the screening or baseline visit, then the participant is a screen fail and may return \>14 days later for a repeat screening visit. If cannabis is again detected at either the screening or baseline visit, then the participant is excluded and not allowed to rescreen.
• History of drug or alcohol dependence; defined by prior inpatient stay(s) for this or that patient states s/he has a history of this.
• Use of dopamine blockers within 180 days and amphetamine, cocaine, and MAO-A inhibitors within 90 days of baseline.
• Currently taking tolcapone, valproic acid, felbamate, niacin (nicotinic acid) at ≥2000 mg/day or nicotinamide (nicotinic acid amide or nicotinamide) at ≥3000 mg/day, isoniazid and ketoconazole due to risk of liver injury and clobazam and ketoconazole because of risk of toxic interactions with the study drug. These medications need to be stopped 90 days before the baseline visit.
• Unstable medical condition.
• Any of the following laboratory test results at screening:
• Hemoglobin \< 10 g/dL WBC \<3.0 x 109/L Neutrophils \<1.5 x 109/L Lymphocytes \< 0.5 x 109/L Platelets \<100 x 109/L Hemoglobin A1C \> 9%
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 times the upper limit of normal. Persons with stable liver disease of known etiology can be included, unless total bilirubin or prothrombin time/INR is abnormal.
• Is pregnant or lactating, or has a positive pregnancy test result pre-dose.
• If a sexually active female, is not surgically sterile or at least two years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least four weeks after the completion of study treatment, using one of the following: barrier methods (diaphragm or partner using condoms plus use of spermicidal jelly or foam, preferably double-barrier methods); oral or implanted hormonal contraceptive; intrauterine device (IUD); or vasectomized male partner.
• Planned elective surgery during study participation.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado Department of Public Health and Environment: collaborator

Study Sites (1)

University of Colorado hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Weber I, Zagona-Prizio C, Sivesind TE, Adelman M, Szeto MD, Liu Y, Sillau SH, Bainbridge J, Klawitter J, Sempio C, Dunnick CA, Leehey MA, Dellavalle RP. Oral Cannabidiol for Seborrheic Dermatitis in Patients With Parkinson Disease: Randomized Clinical Trial. JMIR Dermatol. 2024 Mar 11;7:e49965. doi: 10.2196/49965.

  PMID: 38466972 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Tremor; Anxiety Disorders; Psychotic Disorders; Dyskinesias; Marijuana Abuse; Dermatitis, Seborrheic

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Maureen Leehey, MD
• Organization: University of Colorado

maureen.leehey@cuanschutz.edu

3037248288

Study Officials

• Maureen Leehey

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: July 10, 2018
• Study Start: September 5, 2018
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: July 23, 2024
• Results First Posted: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 20 months after the trial is electronically published.
• Access Criteria: by request from qualified investigators who provide a valid research question; as approved by Principal Investigator

Locations

US (1)