Phase 2
Completed N=61
A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease
Source: ClinicalTrials.gov NCT03582137 ↗Enrolled (actual)
61
Serious AEs
1.6%
Results posted
Jul 2024
Primary outcomePrimary: Change in Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) Scores — -4.5714; -2.7665 units on a scale — p=0.3785
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) Scores |
-4.5714; -2.7665 | 0.3785 |
| SECONDARY The Number of Participants Wtih Treatment-related Adverse Events |
26; 25 | — |
| SECONDARY Change in Liver Function Monitoring --Liver Function Test |
0; 0 | — |
| SECONDARY The Number of Participants Wtih Liver Function Impairment Related Adverse Events |
6; 3; 2; 4; 10; 6 | — |
| SECONDARY Change in Blood Pressure (Systolic) |
-5.4145; -0.9891 | 0.2712 |
| SECONDARY Change in Vital Signs-heart Rate |
0.9459; 0.6326 | 0.8974 |
| SECONDARY Change in Vital Signs--weight |
0.07389; -0.07658 | 0.4643 |
| SECONDARY Change in Vital Signs--temperature (Fahrenheit Degree) |
-0.3069; -0.1882 | 0.6245 |
| SECONDARY Change in Physical Exam |
0; 0 | — |
| SECONDARY Change in Neurological Exam |
0; 0 | — |
| SECONDARY Change in Electrocardiograms |
0; 0 | — |
| SECONDARY Change in Laboratory Values--hematology |
0; 0 | — |
| SECONDARY Change in Laboratory Values--chemistry |
0; 0 | — |
| SECONDARY Change in Montreal Cognitive Assessment (MoCA) |
-0.8341; -0.5000 | 0.5921 |
| SECONDARY Change in Wechsler Test for Adult Reading |
0.4421; -1.4931 | 0.1016 |
| SECONDARY Change in Grooved Pegboard Test |
5.3406; -14.3454 | 0.0661 |
| SECONDARY Change in Symbol Digit Modalities Test |
0.6143; 3.8357 | 0.0880 |
| SECONDARY Change in Paced Auditory Serial Addition Test |
6.9653; 11.9489 | 0.2827 |
| SECONDARY Change in Controlled Oral Word Association Test |
3.1675; 2.5916 | 0.7703 |
| SECONDARY Change in Hopkins Verbal Learning Test-total Learning |
-2.03; -1.30 | 0.1874 |
| SECONDARY Change From Baseline for the Delayed Recall Trials Score of HVLT-R |
-1.16; -0.28 | — |
| SECONDARY Change From Baseline in Hopkins Verbal Learning Test-Delayed Recognition Trial |
0.54; 0.55 | — |
| SECONDARY Change in Judgment of Line Orientation |
0.1367; -1.1626 | 0.1646 |
| SECONDARY Change in Semantic Verbal Fluency |
0.7153; 2.4672 | 0.1093 |
| SECONDARY Change in Anxiety Short Form Response |
-2.1001; -3.4533 | 0.1819 |
| SECONDARY Change in Neuropsychiatric Inventory (NPI) |
-0.3000; -1.2667 | 0.2282 |
| SECONDARY Change in Scales of Outcomes in Parkinson's Disease (SCOPA) Sleep-daytime Sleepiness |
-0.5280; -0.2667 | 0.6167 |
| SECONDARY Change in Depression Short Form |
-1.7300; -2.0367 | 0.8378 |
| SECONDARY Change in Emotional and Behavioral Dyscontrol Short Form |
-3.9870; -4.2733 | — |
| SECONDARY Change in Stanford Sleepiness Scale |
0.2903; -0.03333 | 0.2103 |
| SECONDARY Change in Pain Intensity 3a Short Form |
-3.1209; -2.6169 | 0.7197 |
| SECONDARY Change in Pain Interference 4a Short Form |
-0.1543; -2.7701 | 0.0686 |
| SECONDARY Change in Fatigue Severity Scale |
1.4224; -1.3667 | 0.2339 |
| SECONDARY Change in Movement Disorder Society Unified Parkinson Disease Rating Scale |
-6.2798; -7.2333 | 0.7557 |
| SECONDARY Change in Unified Dyskinesia Rating Scale |
1.4704; -1.4270 | — |
| SECONDARY Change in the Timed UP&GO (TUG) |
-0.5409; -0.5922 | 0.9150 |
| SECONDARY Change in IRLS |
-1.2366; -0.5667 | 0.6164 |
| SECONDARY Change in Rapid Eye Movement Sleep Behavior Disorder Screening Questionnaire (RBDSQ) |
-0.4692; -0.3333 | 0.7550 |
| SECONDARY Change in Overactive Bladder Symptom Score |
-0.09605; 0 | 0.9016 |
| SECONDARY Change in Parkinson's Disease Questionnaire (PDQ-39) |
-4.8005; -4.4788 | 0.9219 |
| SECONDARY Change in EuroQol-5 Dimension-5 Level |
0.05364; 0.02467 | 0.3178 |
| SECONDARY Difference in Proportion of Participants That Discontinue the Study Due to Study Drug Intolerance |
1; 0 | — |
| SECONDARY Change in Total Scores on Items 3.17 and 3.18 in MDS-UPDRS |
-1.1570; -0.1000 | — |
| SECONDARY Change in Item 2.10 in MDS UPDRS |
-0.2280; -0.100 | — |
| SECONDARY Change in Item 3.15 and 3.16 in MDS UPDRS |
-0.4291; -0.6667 | — |
| SECONDARY Change in Rigidity Sub Scores in MDS UPDRS |
-0.3742; -0.6030 | 0.7693 |
| SECONDARY Change in Bradykinesia Sub Scores in MDS UPDRS |
-1.6787; -0.8666 | 0.5285 |
| SECONDARY Change in Axial Sub Scores in MDS UPDRS |
-0.2919; -0.2667 | 0.9463 |
| SECONDARY Change in Bulbar Sub Scores in MDS UPDRS |
-0.3376; -0.03333 | 0.4362 |
| SECONDARY Change in Insomnia Severity Index |
-1.6982; -1.6333 | 0.9327 |
| SECONDARY Change in Pittsburgh Sleep Quality Index |
-0.8226; -1.5000 | — |
| SECONDARY Change in Dermatology Quality of Life Index |
-0.1763; 0.1000 | — |
| SECONDARY Change in the Number of Participants With Presence of Seborrheic Dermatitis From Baseline to Final Visit. |
2; 3 | 0.4401 |
| SECONDARY Change in Non-motor Symptoms Scale for Parkinson's Disease (NMSS) |
-5.8652; -5.0333 | 0.8085 |
| SECONDARY Change in Scales of Outcomes in Parkinson's Disease (SCOPA) - Daytime Sleep (DS) Problems. |
-0.5280; -0.2667 | — |
| SECONDARY Change in Scales of Outcomes in Parkinson's Disease (SCOPA) - Nighttime Sleep (NS) Problems. |
-1.2066; -1.2333 | 0.9674 |
| SECONDARY Change in Modified Dysfunctional Beliefs and Attitudes About Sleep Questionnaire (DBAS-16) |
-2.70; -4.57 | — |
| SECONDARY Change in Wake After Sleep Onset |
-48.89; -1.97 | 0.1128 |
| SECONDARY Difference of Plasma Interleukin 6 Level Between PD and Healthy Control Population |
2.99; 1.59 | — |
| SECONDARY Change in Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale (QUIP-RS) - Total Scores |
-0.24; 0.43 | — |
| SECONDARY Change in The Columbia-Suicide Severity Rating Scale (C-SSRS) |
0; 0 | — |
Eligibility Criteria
Inclusion criteria
- 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 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 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.
Data sourced from ClinicalTrials.gov (NCT03582137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.