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Clinical Trials, and HPO
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Name (Synonyms) | Correlation | |
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drug2331 | Levodopa/Carbidopa (LD/CD) Wiki | 1.00 |
drug3249 | Placebo for Levodopa/Carbidopa (LD/CD) Wiki | 1.00 |
drug3246 | Placebo for ABBV-951 Wiki | 1.00 |
Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study measures the efficacy, safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) [LD/CD] in advanced PD participants to achieve reduction in motor fluctuations. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's Disease. The study has two treatment arms . In one arm, participants will be given ABBV-951 plus oral placebo (does not contain treatment drug). In the second arm, participants will be given placebo solution and LD/CD tablets. Adult participants with advanced PD will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 80 sites across the world. In one arm, participants will receive ABBV-951 solution as a continuous infusion under the skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules containing LD/CD tablets. The treatment duration is 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
Description: "On" time without dyskinesia plus "On" time with non-troublesome dyskinesia are based on the Parkinson's Disease (PD) Diary (normalized to a 16-hour waking day averaged over 3 consecutive days). Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 3 PD Diary days before randomization.
Measure: Change in "On" Time (Hours) Without Troublesome Dyskinesia Time: Baseline (Week 0) Up to Week 12Description: "Off" time is assessed by the PD Diary.
Measure: Change in "Off" Time (Hours) Time: Baseline (Week 0) Up to Week 12Description: Motor Experiences of Daily Living is assessed by Part II of Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The Part II MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 52.
Measure: Change in Motor Experiences of Daily Living Time: Baseline (Week 0) Up to Week 12Description: Sleep symptoms are assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2). The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep.
Measure: Change in Sleep Symptoms Time: Baseline (Week 0) Up to Week 12Description: PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.
Measure: Change in Quality of Life Assessed by PD Questionnaire-39 item (PDQ-39) Time: Baseline (Week 0) Up to Week 12Description: Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up.
Measure: Early Morning "Off" Status Time: At Week 12Description: EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of health related quality of life that can be used in a wide range of health conditions and treatments.
Measure: Change in Quality of Life Assessed by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Time: Baseline (Week 0) Up to Week 12Description: The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.
Measure: Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I Time: Baseline (Week 0) Up to Week 12Description: The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.
Measure: Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III Time: Baseline (Week 0) Up to Week 12Description: The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.
Measure: Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Part IV Time: Baseline (Week 0) Up to Week 12Description: The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.
Measure: Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Total Score of Parts I - III Time: Baseline (Week 0) Up to Week 12Description: PKG wearable device is an innovative mobile health technology that provides continuous, objective, ambulatory assessment of the symptoms of PD including tremor, bradykinesia, dyskinesia, and daytime somnolence.
Measure: Change in PD Symptoms as Assessed by the Parkinson's KinetiGraph/Personal KinetiGraph (PKG) Wearable Device Time: Baseline (Week 0) Up to Week 12Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports