Trial · NCT03582137
Registered outcomes61
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 61
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) Scores | From baseline to the end of 2.5 mg/kg/day of CBD, through 3 weeks | 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. |
| Secondary | The Number of Participants Wtih Treatment-related Adverse Events | 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 an undesirable 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. |
| Secondary | 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. | Liver function tests will be performed and evaluated at each clinic visit from baseline through 3 weeks. The result is reported as the number of participants that had a clinically significant change in 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). |
| Secondary | 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. | 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. |
| Secondary | Change in Blood Pressure (Systolic) | Baseline; at the end of 2.5 mg/kg/day, through 3 weeks | Standing systolic blood pressure measurements will be assessed through 3 weeks. The change may be the value of systolic blood pressure. |
| Secondary | Change in Vital Signs-heart Rate | Baseline; at the end of 2.5 mg/kg/day, through 3 weeks | The change may be Heart rate (beat/minute) while standing. |
| Secondary | Change in Vital Signs--weight | 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. |
| Secondary | Change in Vital Signs--temperature (Fahrenheit Degree) | From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks | The change may be temperature in Fahrenheit degree |
| Secondary | Change in Physical Exam | From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks | The result is reported as the number of participants that had a clinically significant change in the 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. |
| Secondary | Change in Neurological Exam | From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks | The result is reported as the number of participants that had a clinically significant change in the general neurological exam clinical significant findings, including cranial nerves, motor strength, sensation, reflexes, gait, and other movements. |
| Secondary | Change in Electrocardiograms | From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks | The result is reported as the number of participants that had a clinically significant change in the EKG. |
| Secondary | Change in Laboratory Values--hematology | From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks | The result is reported as the number of participants that had a clinically significant change in the values of Hematology parameters, including RBC, WBC, HB, PLT, et al. |
| Secondary | Change in Laboratory Values--chemistry | From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks | The result is reported as the number of participants that had a clinically significant change in the values of the Chemistry profile, including BUN, CR, Electrolyte, glucose, liver function, etc. |
| Secondary | Change in Montreal Cognitive Assessment (MoCA) | 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. |
| Secondary | Change in Wechsler Test for Adult Reading | 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. Wechsler Test of Adult Reading (WTAR) - Word reading tests are an established method of establishing a premorbid estimate of verbal intellectual functioning, which will serve as an estimate of premorbid cognitive reserve. The WTAR comprises 50 words with irregular pronunciations that participants read aloud. The raw score can be transformed to an age-adjusted standard score, which is used to predict IQ (M = 100; SD = 15). Scores higher means better. |
| Secondary | Change in Grooved Pegboard Test | From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks | The change are the scores of Grooved Pegboard Test for the dominant affected hand. Manipulative dexterity, including finger speed, is assessed. Scoring is the time it took the participant to complete the task. Start the clock once the participant starts and stop it once the task has been completed. If after five minutes the participant has not completed the pegboard, stop the participant. The score the higher the worse. |
| Secondary | Change in Symbol Digit Modalities Test | 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 (SDMT). The SDMT is a measure of processing speed and working memory that has proven to be sensitive to cognitive impairment in MS that has both oral and written trials (only the oral trial will be administered given the anticipated difficulty patients will have with tremor). Participants are presented with a key at the top of a page pairing unique symbols with single digits. Participants are required to provide the correct digit with symbols that are presented on the rest of the page. The score is the number of correctly coded items from 0-110. The number of correct responses provided in 90 seconds on the oral trial is recorded. Scores range 0-110 items. The higher the score the better. |
| Secondary | Change in Paced Auditory Serial Addition Test | 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. Paced Auditory Serial Addition Test (PASAT) - The PASAT is a more complex measure of processing speed and working memory in which a series of digits is presented to participants at varying intervals (i.e., 2 seconds, 3 seconds). Participants must add each digit to the immediately preceding digit for the duration of each trial. The number of correct responses for each trial is recorded. The score for the PASAT is the total number correct out of 60 possible answers. The higher, the better. |
| Secondary | Change in Controlled Oral Word Association Test | 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 (COWAT). The COWAT is a measure of speeded verbal fluency and word retrieval in which participants are asked to say as many words as they can that begin with each of three letters for 60 seconds. The total number of words generated across all three trials is recorded. The higher, the better. |
| Secondary | Change in Hopkins Verbal Learning Test-total Learning | 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. Hopkins Verbal Learning Test-Revised (HVLT-R) - The HVLT-R is a measure of verbal learning and memory in which participants are asked to learn a 12-item word list over three trials (total immediate learning). When scoring, the three leaning trials are combined to calculate a total recall score. Score ranges 0-36. The higher, the better. The outcoe measure is reporting the change from baseline in the total leaning score across all three trials. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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