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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03582137
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : January 21, 2019
Sponsor:
Collaborator:
Colorado Department of Public Health and Environment
Information provided by (Responsible Party):
University of Colorado, Denver

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).

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Cannabidiol Other: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's Disease
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBD Cannabis extract oral solution
Cannabidiol (CBD) Cannabis extract oral solution
Drug: Cannabidiol
Subjects randomized to this arm will receive Cannabidiol Cannabis extract oral solution
Other Name: CBD

Placebo Comparator: placebo
Placebo oral solution
Other: Placebo
Subjects randomized to this arm will receive Placebo




Primary Outcome Measures :
  1. Change in Movement Disorders Society-Unified Parkinson's disease rating scale (MDS-UPDRS) Part III (motor examination) scores [ Time Frame: From baseline to the end of 2.5 mg/kg/day of CBD, through 3 weeks ]
    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. Higher values represent a worse outcome.


Secondary Outcome Measures :
  1. Change in Frequency of study-related adverse events [ Time Frame: Every 3-5 days at each dose level, assessed up to 3 weeks ]
    Adverse events (AEs) are collected at each dose level. AEs collection include Serious Adverse Events (SAE), withdrawal symptoms and common AEs. SAE is antoward medical occurrence that results in death, or life-threatening, or inpatient hospitalization or prolongation of existing hospitalization or significant disability or incapacity or in a congenital anomaly/birth defect. Withdrawal and common AEs include headache, anxiety, nausea/vomiting, tremor, chills, decreased concentration, increased concentration, agitation, irritability, sleep disturbances, mood changes, somnolence, fatigue, anorexia, appetite changes, weight loss or gain, diarrhea, convulsion, abdominal pain, weakness, fever and other unexpected AEs. All of the these AEs will be recorded and counted.

  2. Change in Liver function monitoring --Liver function test [ Time Frame: Baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks. ]
    Liver function tests will be performed and evaluated at each clinic visit from baseline through 3 weeks.. The change may be the values of the liver function test, including aspartate aminotransferase (AST), Alanine transaminase (ALT), Gamma-glutamyl transferase (GGT), Alkaline phosphatase (Alk Phos), Total Bilirubin (TB).

  3. Change in Liver monitoring -- liver function impairment related adverse events [ Time Frame: Baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks. ]
    Liver function impairment will be evaluated and then related to adverse events and documented at each clinic visit. The change may be the frequency and severity of liver function impairment related AEs, including nausea/vomiting, diarrhea, abdominal pain, fatigue, weakness, chills, appetite changes, weight loss or gain, fever, etc.

  4. Change in Vital signs-Blood pressure (systolic and diastolic) [ Time Frame: Baseline; at the end of 2.5 mg/kg/day, through 3 weeks ]
    Blood pressure (systolic and diastolic) measurements will be assessed through 3 weeks. The change may be the value of systolic and diastolic blood pressure.

  5. Change in Vital signs-heart rate [ Time Frame: Baseline; at the end of 2.5 mg/kg/day, through 3 weeks ]
    The change may be Heart rate (beat/minute).

  6. Change in Vital signs--respiratory rate [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be respiratory rate per minute

  7. Change in Vital signs--weight [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be weight in kilograms or lbs.

  8. Change in Vital signs--temperature [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be temperature in Celsius or Fahrenheit degree

  9. Change in Physical exam [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be complete physical exam findings, including allergic immunologic, cardiovascular, constitutional symptoms, ENT, endocrine, eyes, gastrointestinal, genitourinary, hematologic, integumentary, musculoskeletal, neurological, psychiatric, respiratory and other symptoms clinical significant findings.

  10. Change in neurological exam [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be general neurological exam clinical significant findings, including cranial nerves, motor strength, sensation, reflexes, gait, and other movements.

  11. Change in Electrocardiograms [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be EKG parameters, including abnormal waveforms of P, Q,R,S, T, and U.

  12. Change in Laboratory Values--hematology [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be the values of Hematology parameters, including RBC, WBC, HB, PLT, et al.

  13. Change in Laboratory Values--chemistry [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be values of Chemistry profile, including BUN, CR, Electrolyte, glucose, liver function, etc.

  14. Change in Montreal Cognitive Assessment (MoCA) [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction. The change may be the scores of MoCA, which is ranging from 0-30. Higher values represent a worse outcome.

  15. Change in Wechsler test for Adult reading [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be the scores of Wechsler test for Adult Reading.

  16. Change in Grooved Pegboard Test [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be the scores of Grooved Pegboard Test.

  17. Change in Symbol digit modalities test [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be the scores of Intellectual functioning estimate, Symbol digit modalities test.

  18. Change in Paced auditory serial addition test [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be the scores of Intellectual functioning estimate, Paced auditory serial addition test.

  19. Change in Controlled oral word association test [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be the scores of Intellectual functioning estimate, Controlled oral word association test.

  20. Change in Hopkins verbal learning test [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be the scores of Intellectual functioning estimate, Hopkins verbal learning test-revised.

  21. Change in Judgment of line orientation [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be the scores of Intellectual functioning estimate, Judgment of line orientation.

  22. Change in semantic verbal fluency [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    The change may be the scores of Semantic verbal fluency.

  23. Change in Anxiety Short Form response [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Comprised of 8 items which has five response options. The change may be the total scores of the 8 items. Higher values represent a worse outcome.

  24. Change in Neuropsychiatric Inventory (NPI) [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Valid and reliable scale to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients. The change may be the scores of NPI. Higher values represent a worse outcome.

  25. Change in Scales of Outcomes in Parkinson's disease (SCOPA) sleep [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Valid, reliable short scale for assessing nighttime sleep and daytime sleepiness in patients with PD. The change may be the sub-scores, including daytime and nighttime sleepiness scores. Higher values represent a worse outcome.

  26. Change in Stanford Sleepiness Scale [ Time Frame: Pre- and 3 hours post- dose at baseline visit ]
    Is a quick and easy way to assess how the participant is feeling. The change may be the scores of the scale 3 hours after dosing compared to pre-dosing. Higher values represent a worse outcome.

  27. Change in Depression short form [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Comprised of 8 items which item has five response options. The change may be the scores of the total 8 items. Higher values represent a worse outcome.

  28. Change in Emotional and behavioral dyscontrol short form [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Comprised of 8 items which item has 5 response options. The change may be the total scores of the 8 items. Higher values represent a worse outcome.

  29. Change in Fatigue severity scale [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Self-report 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity. The change may be the total scores of the 9 items, ranging from 9-63. Higher values represent worse outcome.

  30. Change in Pain Intensity 3a short form [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Assess how much a person hurts. The change may be the score of the short form. Higher values represent a worse outcome.

  31. Change in Pain Interference 4a short form [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Self-reported consequences of pain on relevant aspects of one's life. The change may be the scores of the short form. Higher values represent a worse outcome.

  32. Change in Impulsive-Compulsive disorders in Parkinson's disease rating scale (QUIP-RS) [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    To measure severity of symptoms and support a diagnosis of impulse control disorders and related disorders in PD. The change may be the total and sub scores of QUIP-RS (hobbyism-punding and dopamine dysregulation syndrome). The total QUIP-RS scores is 0-112, total ICD score is 0-64. Subscores Gambling 0-16, sex 0-16, buying 0-16, eating 0-16, hobbyism-punding 0-32, and PD Medication use 0-16. Higher values represent a worse outcome.

  33. Change in The Columbia-Suicide Severity rating scale (C-SSRS) [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Is a suicidal ideation rating scale. The change may be the answers to the questions of C-SSRS. There are ten categories and have binary responses (yes/no). Suicidal ideation score: the maximum suicidal ideation category (1-5 on the C-SSRS) present at the assessment. Assign a score of 0 if no ideation is present. Higher values represent a worse outcome.

  34. Change in MDS-UPDRS [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Movement Disorder Society Unified Parkinson Disease Rating Scale. There are four parts, non-motor experiences of daily living, motor experiences of daily living, motor examination, and motor complications. The change may be the total scores of the four parts. Higher values represent a worse outcome.

  35. Change in Unified Dyskinesia Rating Scale [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    To evaluate involuntary movements often associated with treated PD. The change may be the total scores of the scale, including historical sub-score (0-60) and objective sub-score (0-44). The total score is historical sub score plus objective sub score, ranged from 0- 104. Higher values represent a worse outcome.

  36. Change in Smartphone-based timed UP&GO (TUG) [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    To evaluate balance and walking ability associated with advancing age, neurological or other disorders. The change may be the time duration of performing the tusk.

  37. Change in IRLS [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    International restless legs syndrome (IRLS) study group rating scale for restless legs syndrome. The change may be the scroes of the IRLS, ranged from 0-40. Higher values represent a worse outcome.

  38. Change in RBDSQ [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    REM sleep behavior disorder screening questionnaire (RBDSQ). The change may be the total scores of RBDSQ. Maximum total score 13 points. Higher values represent a worse outcome.

  39. Change in Overactive bladder symptom score [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    A validated self-administered questionnaire consisting of 7 questions on a 5-point Likert scale. The change may be the scores of the scale, ranged from 0-35. Higher values represent a worse outcome.

  40. Change in Parkinson's disease questionnaire (PDQ-39) [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    A reliable valid responsive acceptable and feasible tool for assessment of quality of life in PD, including 390multiple-choice items covering 8 dimensions: mobility (#1-10), activities of daily living (#11-16), emotional well-being (#17-22), stigma (#23-26), social support (#27-29), cognition (#30-33), communication (#34-36), and bodily discomfort (#37-39). 5-point ordinal scoring system: 0=never, 1= occasionally, 2=sometimes, 3=often, 4=always. The change may be the total scores of PDQ-39, ranged from 0-156. Higher values represent a worse outcome.

  41. Change in EuroQol-5 Dimension-5 level [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Consists of 2 pages-the EuroQol-5 Dimension-5 level (EQ-5D-5L) descriptive system and the EuroQol (EQ) Visual analogue scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The VAS records the patient's self-rated health on a vertical visual analogue-scale, where the endpoints are labelled the best health you can imagine and the worst health you can imagine. The change may be the scales of EQ-5D.

  42. Change in Proportion of participants that discontinue the study due to study drug intolerance [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Change in Proportion of participants that discontinue the study due to study drug intolerance. The change may be the number of patients dropped out.

  43. Change in Total scores on items 3.17 and 3.18 in MDS-UPDRS [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Rest tremor amplitude and constancy of rest tremor scores in MDS UPDRS. The change may be the sum scores of 3.17 and 3.18. Score ranged from 0-24. Higher values represent a worse outcome.

  44. Change in Item 2.10 in MDS UPDRS [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Patient's tremor experience. The change may be the scores of item 2.10. Score ranged from 0-4. Higher values represent a worse outcome.

  45. Change in Item 3.15 and 3.16 in MDS UPDRS [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Postural tremor of the hands and kinetic tremor of the hand. The change may be the sum scores of item 3.15 and 3.16. Score ranged from 0-16. Higher values represent a worse outcome.

  46. Change in Rigidity sub scores in MDS UPDRS [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Rigidity sub scores in MDS UPDRS. The change may be the sub scores of rigidity related item in MDS UPDRS (item 3.3). Score ranged from 0-20. Higher values represent a worse outcome.

  47. Change in Bradykinesia sub scores in MDS UPDRS [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Bradykinesia sub scores in MDS UPDRS. The change may be the sub scores of bradykinesia related itmes in MDS UPDRS, including items 3.4-3.8, and 3.14. The scores ranged from 0-44. Higher values represent a worse outcome.

  48. Change in Axial sub scores in MDS UPDRS [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Axial sub scores in MDS UPDRS. The change may be the sub scores of axial related items in MDS UPDRS, including items 3.9, 3.13, 3.10, 3.11, and 3.12. The sub scores ranged from 0-20. Higher values represent a worse outcome.

  49. Change in Bulbar sub scores in MDS UPDRS [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Bulbar sub scores in MDS UPDRS (item 3.1 and 3.2). The change may be the sub scores of bulbar related items in MDS UPDRS, ranged from 0-8. Higher values represent a worse outcome.

  50. Change in Insomnia severity index [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The change may be the scores of ISI. Total scores is the sum of the all seven items. 0-7=no clinically significant insomnia. 8-14=subthreshold insomnia. 15-21=clinical insomnia (moderate severity). 22-28=clinical insomnia (severe). Higher values represent a worse outcome.

  51. Change in Modified dysfunctional beliefs and attitudes about sleep questionnaire [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Self reported questionnaire to identify and assess various sleep/insomnia-related cognition (e.g., beliefs, attitudes, expectations, appraisals, attributions). For each statement, the person rates his or her level of agreement/disagreement on a 100-mm visual analog scale anchored at one end by strongly disagree and at the other by strongly agree. The change may be the scores of the questionnaire.

  52. Change in Pittsburgh sleep quality index [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    To measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. The change may be the total scores, ranged from 0 to 42. The higher values represent a worse outcome.

  53. Change in Home sleep monitoring (polysomnograph, PSG) [ Time Frame: Home sleep monitoring will be measured only once, the day prior to 2.5 mg/kg/day assessment visit. ]
    Home sleep monitory with polysomnograph. The change may be the values of the PSG parameters compared to the value of normal population. The higher values represent a worse outcome.

  54. Change in Dermatology Quality of Life Index [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Dermatology quality of life index. The change may be the scores of the questionnaire. The scoring of each question is as follows: very much=3, a lot =2, a little=1, not at all=0, not relevant =0. Question 7, prevented work or studying =3. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

  55. Change in Dermatology photography evaluation [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Dermatology photography evaluation. The change may be the severity and distribution of skin disease.

  56. Change in Non-motor symptoms Scale for Parkinson's disease (NMSS) [ Time Frame: From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks ]
    Validated 30-item scale for the assessment of NMS in PD. Each symptom scored with respect to severity (0=none, 1=mild, 2=moderate, 3=severe), frequency (1=rarely, 2=often, 3=frequent, 4=very frequent). The change may be the total scores of NMSS, ranged from 0 to 360. The higher values represent a worse outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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<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.

Exclusion criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582137


Contacts
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Contact: Nicola Haakonsen 303-724-4644 Nicola.Haakonsen@ucdenver.edu
Contact: Ying Liu 303-724-8288 YING.3.LIU@UCDENVER.EDU

Locations
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United States, Colorado
University of Colorado hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Nicola Haakonsen    303-724-4644    nicola.haakonsen@ucdenver.edu   
Contact: Ying Liu    303-724-8288    ying.3.liu@ucdenver.edu   
Principal Investigator: Maureen Leehey, M.D.         
Sponsors and Collaborators
University of Colorado, Denver
Colorado Department of Public Health and Environment
Investigators
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Principal Investigator: Maureen Leehey University of Colorado School of Medicine

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03582137     History of Changes
Other Study ID Numbers: 17-2318
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
sleep
Parkinson's Disease
Motor symptoms
Tremor
tolerability
safety
cognition
anxiety
psychosis
mood
dyskinesia
cannabidiol
cannabis
efficacy
non-motor symptoms
quality of life
seborrhea

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pharmaceutical Solutions
Epidiolex
Anticonvulsants