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| ID | Type | Description | Link |
|---|---|---|---|
| U01NS080818-01A1 | U.S. NIH Grant/Contract | View source | |
| U01NS080840-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
| The Parkinson Study Group | NETWORK |
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The purpose of the study is to determine whether treatment with isradipine is effective in slowing the progression of Parkinson disease disability.
The study will enroll 336 participants in this multi-center study at approximately 56 sites across the US and Canada. In this study, we are comparing 10 mg of Isradipine to Placebo for treatment of newly diagnosed PD patients. Isradipine has been approved by the Food and Drug Administration (FDA) to treat high blood pressure but is considered investigational in this study, as it has not been approved for use in patients with PD.Isradipine can affect the function of specialized channels that are present in the types of brain cells that are affected in PD patient. These cells are usually responsible for making dopamine, which is depleted in patients with PD. Isradipine may block the damage caused by the flow of certain chemicals through these channels. Laboratory data has showed that Isradipine may prevent the development of Parkinson-like symptoms in animal studies. Isradipine has been evaluated in some patients with PD. The first study with isradipine controlled release (CR) in patients with early PD and normal blood pressure found that the drug was reasonably well tolerated and safe. The controlled release formulation of isradipine is not available for use and therefore this study is using the immediate release formulation. Eligible participants will be followed for up to 36 months and will be expected to complete 12 in-person visits and 4 telephone visits. The study visits will include clinical assessment of motor, neuropsychiatric and cognitive testing as well as collection of blood and urine samples. Study drug will taken twice daily, in the morning and in the evening with or without food. Prior to taking study drug, study participants will be required to take their blood pressure with a home blood pressure device provided to them for use in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isradipine | Active Comparator | Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months. |
|
| Placebo (for Isradipine) | Placebo Comparator | Oral capsule taken twice daily for 36 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isradipine | Drug | Oral capsules Isradipine IR, up to 10 mg, taken twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in Total Unified Parkinson Disease Rating Scale (UPDRS) Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the total (Part I-III) UPDRS score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -30 to 80, larger value shows more disability from PD. | Baseline to 36 months of treatment |
| Adjusted Mean Change in Adjusted UPDRS Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the adjusted UPDRS Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of adjusted UPDRS ranges from -100 to 150, larger value shows more disability from PD. | Baseline to 36 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in LED | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the LED(levodopa equivalent dose) in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED ranges from -100 to 3000, larger value shows more disability from PD. | Baseline to 36 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in UPDRS PIGD Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS PIGD Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS PIGD Score ranges from -1 to 3, larger value shows worsening of conditions. | Baseline to 36 months of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanya Simuni, MD | Northwestern University | Principal Investigator |
| Robert Holloway, MD MPH | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Banner Sun Health Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36865634 | Derived | Di Luca DG, Macklin EA, Hodgeman K, Lopez G, Pothier L, Callahan KF, Lowell J, Chan J, Videnovic A, Lungu C, Lang AE, Litvan I, Schwarzschild MA, Simuni T. Enrollment of Participants From Marginalized Racial and Ethnic Groups: A Comparative Assessment of the STEADY-PD III and SURE-PD3 Trials. Neurol Clin Pract. 2023 Feb;13(1):e200113. doi: 10.1212/CPJ.0000000000200113. Epub 2023 Jan 18. | |
| 33460320 | Derived | Venuto CS, Yang L, Javidnia M, Oakes D, James Surmeier D, Simuni T. Isradipine plasma pharmacokinetics and exposure-response in early Parkinson's disease. Ann Clin Transl Neurol. 2021 Mar;8(3):603-612. doi: 10.1002/acn3.51300. Epub 2021 Jan 18. |
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413 patients were assessed for eligibility. 12 patients declined to participate and 65 patients were excluded (9 exclusionary medications, 2 other medical psychiatric or surgical, 5 disease too advanced, 6 diagnosis uncertain, 23 didn't meet other inclusion criteria, 20 other). 336 patients were enrolled and underwent randomization
Patients were recruited from 57 Parkinson Study Group sites in North America from November 2014 through November 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Isradipine | Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day. |
| FG001 | Placebo (for Isradipine) | Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2016 | Nov 25, 2019 |
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| Placebo (for Isradipine) |
| Drug |
Sugar Pill manufactured to look like Isradipine but has no active ingredients |
|
| Adjusted Mean Change in LED Cumulative | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the LED(levodopa equivalent dose) cumulative in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED cumulative ranges from 0 to 1200000, larger value shows more disability from PD. | Baseline to 36 months of treatment |
| Adjusted Mean Change in UPDRS Part IV | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part IV in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part IV ranges from -10 to 10, larger value shows more disability from PD. | Baseline to 36 months of treatment |
| Adjusted Mean Change in MDS-UPDRS nmEDL | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS nmEDL(Non-Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MDS-UPDRS nmEDL ranges from -6 to 10, larger value shows more disability from PD. | Baseline to 36 months of treatment |
| Adjusted Mean Change in MDS-UPDRS mEDL | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS mEDL(Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MDS-UPDRS mEDL ranges from -8 to 35, larger value shows more disability from PD. | Baseline to 36 months of treatment |
| Adjusted Mean Change in UPDRS Score to 1 Year | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS nmEDL(Non-Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 12 month visit. The change of UPDRS ranges from -22 to 23, larger value shows more disability from PD. | Baseline to 12 months of treatment |
| Adjusted Mean Change in UPDRS Part II | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part II (ADL Function) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part II ranges from -12 to 19, larger value shows more disability from PD. | Baseline to 36 months of treatment |
| Adjusted Mean Change in UPDRS Part III OFF | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part III OFF rating in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part III OFF ranges from -30 to 100, larger value shows more disability from PD. | Baseline to 36 months of treatment |
| Adjusted Mean Change in SE/ADL | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the SE/ADL in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -70 to 20, larger value shows improvement of PD. | Baseline to 36 months of treatment |
| Adjusted Mean Change in Modified Rankin Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Modified Rankin Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Modified Rankin Score ranges from -1 to 3, larger value shows worsening of conditions. | Baseline to 36 months of treatment |
| Adjusted Mean Change in MoCA Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MoCA Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MoCA Score ranges from -10 to 6, larger value shows improvement of conditions. | Baseline to 36 months of treatment |
| Adjusted Mean Change in PDQ39 Total Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the PDQ39 Total Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in PDQ39 Total Score ranges from -16 to 44, larger value shows worsening of conditions. | Baseline to 36 months of treatment |
| Adjusted Mean Change in Ambulatory Capacity | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Ambulatory Capacity in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Ambulatory Capacity ranges from -4 to 12, larger value shows worsening of conditions. | Baseline to 36 months of treatment |
| Adjusted Mean Change in BDI Total Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the BDI Total Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in BDI Total Score ranges from -9 to 22, larger value shows worsening of conditions. | Baseline to 36 months of treatment |
| Risk of Need for Antiparkinsonian Therapy | Number of participants with need for Antiparkinsonian Therapy. | Baseline to 36 months of treatment |
| Risk of Need for Dyskinesia | Number of participants with need for Dyskinesia Therapy. | Baseline to 36 months of treatment |
| Risk of Need for Fluctuations | Number of participants with need for Fluctuations Therapy. | Baseline to 36 months of treatment |
| Adjusted Mean Change in UPDRS Tremor Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Tremor Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Tremor Score ranges from -1 to 2, larger value shows worsening of conditions. | Baseline to 36 months of treatment |
| Adjusted Mean Change in H/Y Stage | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the H/Y Stage in the active treatment arm versus placebo between the baseline and 36 month visit. The change in H/Y Stage ranges from -1 to 3, larger value shows worsening of conditions. | Baseline to 36 months of treatment |
| Adjusted Mean Change in Levodopa | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Levodopa in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED ranges from -200 to 2000, larger value shows more disability from PD. | Baseline to 36 months of treatment |
| Adjusted Mean Change in Levodopa Cumulative | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Levodopa Cumulative in the active treatment arm versus placebo between the baseline and 36 month visit. The change of Levodopa cumulative ranges from 0 to 800000, larger value shows more disability from PD. | Baseline to 36 months of treatment |
| Adjusted Mean Change in Systolic BP, Seated | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Systolic BP, Seated in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Systolic BP, Seated ranges from -65 to 50. larger value shows worsening of conditions. | Baseline to 36 months of treatment |
| Adjusted Mean Change in Diastolic BP, Seated | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Diastolic BP, Seated in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Diastolic BP, Seated ranges from -35 to 25. larger value shows worsening of conditions. | Baseline to 36 months of treatment |
| Sun City |
| Arizona |
| 85315 |
| United States |
| The Parkinsons & Movement Disorder Institute | Fountain Valley | California | 92708 | United States |
| University of California | Irvine | California | 92697 | United States |
| University of California San Diego | San Diego | California | 92093 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Rocky Mountain Movement Disorders Center | Englewood | Colorado | 80113 | United States |
| Institute of Neurodegenerative Disorders | New Haven | Connecticut | 06510 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30329 | United States |
| Pacific Health Research & Education Institute | Honolulu | Hawaii | 96819 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| LSU Health Science Center | Shreveport | Louisiana | 71103 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston University Medical Center | Boston | Massachusetts | 02118 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| Struthers Parkinson's Center | Golden Valley | Minnesota | 55427 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| University of Nevada School of Medicine | Las Vegas | Nevada | 89102 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Atlantic Neuroscience Institute | Summit | New Jersey | 07901 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| Health Quest Kingston | Kingston | New York | 12401 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Weill Medical College of Cornell University | New York | New York | 20021 | United States |
| University of Rochester | Rochester | New York | 14618 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43221 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29401 | United States |
| University of Texas Health Science Center | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Sentara Neurology Specialists | Virginia Beach | Virginia | 23456 | United States |
| Booth Gardner Parkinson's Care Center | Kirkland | Washington | 98034 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | t6g 2g3 | Canada |
| Ottawa Hospital Civic Site | Ottawa | Ontario | K1Y 4E9 | Canada |
| The Centre for Addiction and Mental Health | Toronto | Ontario | m3b 2s7 | Canada |
| Toronto Western Hospital, University Health Network | Toronto | Ontario | M5T 2S8 | Canada |
| CHUM - Hopital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| Centre Hospitalier Affilie | Québec | Quebec | G1J 1Z4 | Canada |
| 32227247 | Derived | Parkinson Study Group STEADY-PD III Investigators. Isradipine Versus Placebo in Early Parkinson Disease: A Randomized Trial. Ann Intern Med. 2020 May 5;172(9):591-598. doi: 10.7326/M19-2534. Epub 2020 Mar 31. |
| 30741695 | Derived | McFarthing K, Simuni T. Clinical Trial Highlights: Phase III Study in Spotlight. J Parkinsons Dis. 2019;9(1):3-4. doi: 10.3233/JPD-190002. No abstract available. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Isradipine | Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months. Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily |
| BG001 | Placebo (for Isradipine) | Oral capsule taken twice daily for 36 months. Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Enrolled patients were from 54 Parkinson Study Group sites in North America. 7 locate in Canada and 47 locate in United States. | Number | participants |
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| Disease Duration | Months from diagnosis. | Mean | Standard Deviation | months |
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| Family History of PD | First degree relatives only | Count of Participants | Participants |
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| Handedness | Count of Participants | Participants |
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| On Symptomatic Therapy (Amantadine) | Count of Participants | Participants |
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| On Symptomatic Therapy (Anticholinergics) | Count of Participants | Participants |
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| UPDRS Total Score | Baseline total Unified Parkinson Disease Rating Scale (UPDRS) score ranges from 0 to 52. Larger value stands for more disability from PD. | One participant had missing baseline UPDRS | Mean | Standard Deviation | units on a scale |
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| Mental Scale | Baseline UPDRS Mental (UPDRS Part I: Mentation, Behavior, and Mood) score ranges from 0 to 7. Larger value stands for more disability from PD. | One participant had missing baseline UPDRS | Mean | Standard Deviation | units on a scale |
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| ADL Scale | Baseline UPDRS ADL (Part II) score ranges from 0 to 16. Larger value stands for more disability from PD. UPDRS Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food. | One participant had missing baseline UPDRS | Mean | Standard Deviation | units on a scale |
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| Motor Scale | Baseline UPDRS Motor (Part III) score ranges from 0 to 42. Larger value stands for more disability from PD. UPDRS part III: clinician-scored monitored motor evaluation | One participant had missing baseline UPDRS | Mean | Standard Deviation | units on a scale |
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| UPSDRS PIGD Score | Baseline UPDRS PIGD score ranges from 0 to 1. Larger value stands for more disability from PD. | One participant had missing baseline UPDRS PIGD Score | Mean | Standard Deviation | units on a scale |
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| UPDRS Tremor Score | Baseline UPDRS Tremor score ranges from 0 to 1.63. Larger value stands for more disability from PD. | One participant had missing baseline UPDRS Tremor Score | Mean | Standard Deviation | units on a scale |
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| H/Y Stage | Hoehn and Yahr staging of severity of Parkinson's disease. Baseline H/Y stage ranges from 1 to 3. Larger value stands for more disability from PD. | Mean | Standard Deviation | units on a scale |
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| SE/ADL | Schwab and England ADL scale. Baseline SE/ADL ranges from 40 to 100. Smaller value stands for more disability from PD. | Mean | Standard Deviation | units on a scale |
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| Modified Rankin Score | The modified Rankin Scale (mRS) measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Baseline Modified Rankin score ranges from 0 to 2. Larger value stands for more disability from PD. | Mean | Standard Deviation | units on a scale |
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| MoCA Score | Montreal Cognitive Assessment (MoCA) is one-page 30-point test to detect cognitive impairment. Baseline MoCA score ranges from 23 to 30. Higher scores indicate better cognition. | Mean | Standard Deviation | units on a scale |
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| BDI Total Score | Baseline Beck Depression Inventory (BDI) score ranges from 0 to 23. Higher scores indicate greater symptom severity. | Mean | Standard Deviation | units on a scale |
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| PDQ39 Total Score | Parkinson's Disease Questionnaire-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the past month. Baseline PDQ 39 score ranges from 0 to 52. Lower score shows better quality of life. | Mean | Standard Deviation | units on a scale |
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| Systolic BP, Seated | Mean | Standard Deviation | mmHg |
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| Diastolic BP, Seated | Mean | Standard Deviation | mmHg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adjusted Mean Change in Total Unified Parkinson Disease Rating Scale (UPDRS) Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the total (Part I-III) UPDRS score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -30 to 80, larger value shows more disability from PD. | Intention-to-treat (ITT) population | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 36 months of treatment |
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| Primary | Adjusted Mean Change in Adjusted UPDRS Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the adjusted UPDRS Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of adjusted UPDRS ranges from -100 to 150, larger value shows more disability from PD. | Intention-to-treat (ITT) population | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 36 months of treatment |
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| Secondary | Adjusted Mean Change in LED | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the LED(levodopa equivalent dose) in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED ranges from -100 to 3000, larger value shows more disability from PD. | Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline LED measurement. So LED had 1 more observation than primary outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | mg | Baseline to 36 months of treatment |
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| Secondary | Adjusted Mean Change in LED Cumulative | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the LED(levodopa equivalent dose) cumulative in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED cumulative ranges from 0 to 1200000, larger value shows more disability from PD. | Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline LED Cumulative measurement. So LED Cumulative had 1 more observation than primary outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | mg | Baseline to 36 months of treatment |
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| Secondary | Adjusted Mean Change in UPDRS Part IV | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part IV in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part IV ranges from -10 to 10, larger value shows more disability from PD. | Intention-to-treat (ITT) population. 46 patients had missing measures at the visit of 36 months. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 36 months of treatment |
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| Secondary | Adjusted Mean Change in MDS-UPDRS nmEDL | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS nmEDL(Non-Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MDS-UPDRS nmEDL ranges from -6 to 10, larger value shows more disability from PD. | Intention-to-treat (ITT) population. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 36 months of treatment |
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| Secondary | Adjusted Mean Change in MDS-UPDRS mEDL | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS mEDL(Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MDS-UPDRS mEDL ranges from -8 to 35, larger value shows more disability from PD. | Intention-to-treat (ITT) population | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 36 months of treatment |
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| Secondary | Adjusted Mean Change in UPDRS Score to 1 Year | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS nmEDL(Non-Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 12 month visit. The change of UPDRS ranges from -22 to 23, larger value shows more disability from PD. | Intention-to-treat (ITT) population. There were 169 patients in Isradipine group and 165 in placebo group who reached 1-year visit. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 12 months of treatment |
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| Secondary | Adjusted Mean Change in UPDRS Part II | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part II (ADL Function) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part II ranges from -12 to 19, larger value shows more disability from PD. | Intention-to-treat (ITT) population | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 36 months of treatment |
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| Secondary | Adjusted Mean Change in UPDRS Part III OFF | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part III OFF rating in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part III OFF ranges from -30 to 100, larger value shows more disability from PD. | Intention-to-treat (ITT) population. 58 patients had missing measures at the visit of 36 months. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 36 months of treatment |
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| Secondary | Adjusted Mean Change in SE/ADL | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the SE/ADL in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -70 to 20, larger value shows improvement of PD. | Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline SE/ADL measurement. So SE/ADL had 1 more observation than primary outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change in Modified Rankin Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Modified Rankin Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Modified Rankin Score ranges from -1 to 3, larger value shows worsening of conditions. | Intention-to-treat (ITT) population. One participant had missing baseline measurement for primary efficacy while had finished baseline Modified Rankin Score. So Modified Rankin Score had 1 more observation than primary outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change in MoCA Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MoCA Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MoCA Score ranges from -10 to 6, larger value shows improvement of conditions. | Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline MoCA Score. So MoCA Score had 1 observation more than primary outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change in PDQ39 Total Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the PDQ39 Total Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in PDQ39 Total Score ranges from -16 to 44, larger value shows worsening of conditions. | Intention-to-treat (ITT) population. 7 patients had missing PDQ39 scores at the visit of 36 months. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change in Ambulatory Capacity | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Ambulatory Capacity in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Ambulatory Capacity ranges from -4 to 12, larger value shows worsening of conditions. | Intention-to-treat (ITT) population | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change in BDI Total Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the BDI Total Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in BDI Total Score ranges from -9 to 22, larger value shows worsening of conditions. | Intention-to-treat (ITT) population. One participant in Placebo group had missing baseline UPDRS sections while had finished baseline BDI Score. And one participant in Isradipine group had missing BDI score at the visit of 36 months. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Risk of Need for Antiparkinsonian Therapy | Number of participants with need for Antiparkinsonian Therapy. | Include all 336 patients that were randomized, no matter whether or not completed the study. | Posted | Number | 95% Confidence Interval | participants | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Risk of Need for Dyskinesia | Number of participants with need for Dyskinesia Therapy. | Include all 336 patients that were randomized, no matter whether or not completed the study. | Posted | Number | 95% Confidence Interval | participants | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Risk of Need for Fluctuations | Number of participants with need for Fluctuations Therapy. | Include all 336 patients that were randomized, no matter whether or not completed the study. | Posted | Number | 95% Confidence Interval | participants | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change in UPDRS PIGD Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS PIGD Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS PIGD Score ranges from -1 to 3, larger value shows worsening of conditions. | Intention-to-treat (ITT) population | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change in UPDRS Tremor Score | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Tremor Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Tremor Score ranges from -1 to 2, larger value shows worsening of conditions. | Intention-to-treat (ITT) population | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change in H/Y Stage | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the H/Y Stage in the active treatment arm versus placebo between the baseline and 36 month visit. The change in H/Y Stage ranges from -1 to 3, larger value shows worsening of conditions. | Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline H/Y Stage. So H/Y Stage had 1 observation more than primary outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change in Levodopa | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Levodopa in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED ranges from -200 to 2000, larger value shows more disability from PD. | Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Levodopa. So Levodopa had 1 observation more than primary outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | mg | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change in Levodopa Cumulative | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Levodopa Cumulative in the active treatment arm versus placebo between the baseline and 36 month visit. The change of Levodopa cumulative ranges from 0 to 800000, larger value shows more disability from PD. | Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Levodopa Cumulative. So Levodopa Cumulative had 1 observation more than primary outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | mg | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change in Systolic BP, Seated | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Systolic BP, Seated in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Systolic BP, Seated ranges from -65 to 50. larger value shows worsening of conditions. | Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Systolic BP, Seated. So Systolic BP had 1 observation more than primary outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline to 36 months of treatment |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change in Diastolic BP, Seated | Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Diastolic BP, Seated in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Diastolic BP, Seated ranges from -35 to 25. larger value shows worsening of conditions. | Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Diastolic BP, Seated. So Diastolic BP had 1 observation more than primary outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline to 36 months of treatment |
|
|
Baseline to 36 months of treatment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Isradipine | Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months. Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily | 2 | 170 | 26 | 170 | 163 | 170 |
| EG001 | Placebo (for Isradipine) | Oral capsule taken twice daily for 36 months. Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients | 1 | 166 | 27 | 166 | 154 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| ARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | Systematic Assessment |
| ||
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| SEPSIS | Infections and infestations | Systematic Assessment |
| ||
| STRESS FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| SYNCOPE | Nervous system disorders | Systematic Assessment |
| ||
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | Systematic Assessment |
| ||
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| APHASIA | Nervous system disorders | Systematic Assessment |
| ||
| APPENDICEAL MUCOCOELE | Gastrointestinal disorders | Systematic Assessment |
| ||
| APPENDICITIS | Infections and infestations | Systematic Assessment |
| ||
| APPENDICITIS PERFORATED | Infections and infestations | Systematic Assessment |
| ||
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| B-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| BASAL GANGLIA HAEMORRHAGE | Nervous system disorders | Systematic Assessment |
| ||
| BRADYCARDIA | Cardiac disorders | Systematic Assessment |
| ||
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| BRONCHIOLITIS | Infections and infestations | Systematic Assessment |
| ||
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | Systematic Assessment |
| ||
| CHEST DISCOMFORT | General disorders | Systematic Assessment |
| ||
| CHOROID MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| DEHYDRATION | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| DYSPHAGIA | Gastrointestinal disorders | Systematic Assessment |
| ||
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| GASTROENTERITIS VIRAL | Infections and infestations | Systematic Assessment |
| ||
| HALLUCINATION, VISUAL | Psychiatric disorders | Systematic Assessment |
| ||
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| HYPERTENSIVE ENCEPHALOPATHY | Nervous system disorders | Systematic Assessment |
| ||
| INTRAVENTRICULAR HAEMORRHAGE | Nervous system disorders | Systematic Assessment |
| ||
| ISCHAEMIC STROKE | Nervous system disorders | Systematic Assessment |
| ||
| MENINGITIS | Infections and infestations | Systematic Assessment |
| ||
| MENORRHAGIA | Reproductive system and breast disorders | Systematic Assessment |
| ||
| METASTATIC SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
| ||
| NEPHROLITHIASIS | Renal and urinary disorders | Systematic Assessment |
| ||
| PANCREATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| PITUITARY TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| PNEUMONIA | Infections and infestations | Systematic Assessment |
| ||
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PYELONEPHRITIS ACUTE | Infections and infestations | Systematic Assessment |
| ||
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | Systematic Assessment |
| ||
| SPINA BIFIDA | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| SPINAL FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| STRESS CARDIOMYOPATHY | Cardiac disorders | Systematic Assessment |
| ||
| SUICIDAL IDEATION | Psychiatric disorders | Systematic Assessment |
| ||
| THROAT CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| URINARY RETENTION | Renal and urinary disorders | Systematic Assessment |
| ||
| URINARY TRACT INFECTION | Infections and infestations | Systematic Assessment |
| ||
| WRIST FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIZZINESS | Nervous system disorders | Systematic Assessment |
| ||
| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
| ||
| HEADACHE | Nervous system disorders | Systematic Assessment |
| ||
| OEDEMA | General disorders | Systematic Assessment |
| ||
| NASOPHARYNGITIS | Infections and infestations | Systematic Assessment |
| ||
| FATIGUE | General disorders | Systematic Assessment |
| ||
| CONSTIPATION | Gastrointestinal disorders | Systematic Assessment |
| ||
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| INSOMNIA | Psychiatric disorders | Systematic Assessment |
| ||
| ANXIETY | Psychiatric disorders | Systematic Assessment |
| ||
| DEPRESSION | Psychiatric disorders | Systematic Assessment |
| ||
| BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Systematic Assessment |
| ||
| FALL | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| SINUSITIS | Infections and infestations | Systematic Assessment |
| ||
| COUGH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| SOMNOLENCE | Nervous system disorders | Systematic Assessment |
| ||
| HYPOAESTHESIA | Nervous system disorders | Systematic Assessment |
| ||
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| SLEEP DISORDER | Psychiatric disorders | Systematic Assessment |
| ||
| BRONCHITIS | Infections and infestations | Systematic Assessment |
| ||
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | Systematic Assessment |
| ||
| HYPERTENSION | Vascular disorders | Systematic Assessment |
| ||
| DIARRHOEA | Gastrointestinal disorders | Systematic Assessment |
| ||
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| CATARACT | Eye disorders | Systematic Assessment |
| ||
| DYSPHAGIA | Gastrointestinal disorders | Systematic Assessment |
| ||
| POLLAKIURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| TREMOR | Nervous system disorders | Systematic Assessment |
| ||
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| RAPID EYE MOVEMENTS SLEEP ABNORMAL | Psychiatric disorders | Systematic Assessment |
| ||
| URINARY TRACT INFECTION | Infections and infestations | Systematic Assessment |
| ||
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RASH | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| DYSTONIA | Nervous system disorders | Systematic Assessment |
| ||
| TENDONITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| NEPHROLITHIASIS | Renal and urinary disorders | Systematic Assessment |
| ||
| MYALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| CHEST PAIN | General disorders | Systematic Assessment |
| ||
| ORTHOSTATIC HYPOTENSION | Vascular disorders | Systematic Assessment |
| ||
| INFLUENZA | Infections and infestations | Systematic Assessment |
| ||
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Systematic Assessment |
| ||
| MICTURITION URGENCY | Renal and urinary disorders | Systematic Assessment |
| ||
| DIVERTICULITIS | Infections and infestations | Systematic Assessment |
| ||
| LACERATION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| HYPOTENSION | Vascular disorders | Systematic Assessment |
| ||
| PARAESTHESIA | Nervous system disorders | Systematic Assessment |
| ||
| VISION BLURRED | Eye disorders | Systematic Assessment |
| ||
| ABNORMAL LOSS OF WEIGHT | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | Systematic Assessment |
| ||
| BLOOD CREATININE INCREASED | Investigations | Systematic Assessment |
| ||
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | Systematic Assessment |
| ||
| MUSCLE STRAIN | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| SCIATICA | Nervous system disorders | Systematic Assessment |
| ||
| VERTIGO | Ear and labyrinth disorders | Systematic Assessment |
| ||
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | Systematic Assessment |
| ||
| DYSPEPSIA | Gastrointestinal disorders | Systematic Assessment |
| ||
| INGUINAL HERNIA | Gastrointestinal disorders | Systematic Assessment |
| ||
| PALPITATIONS | Cardiac disorders | Systematic Assessment |
| ||
| RESTLESS LEGS SYNDROME | Nervous system disorders | Systematic Assessment |
| ||
| FLUSHING | Vascular disorders | Systematic Assessment |
| ||
| BRADYKINESIA | Nervous system disorders | Systematic Assessment |
| ||
| DRY EYE | Eye disorders | Systematic Assessment |
| ||
| HALLUCINATION | Psychiatric disorders | Systematic Assessment |
| ||
| PAIN | General disorders | Systematic Assessment |
| ||
| PLANTAR FASCIITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| PROTEINURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| VOMITING | Gastrointestinal disorders | Systematic Assessment |
| ||
| ABDOMINAL PAIN | Gastrointestinal disorders | Systematic Assessment |
| ||
| HOT FLUSH | Vascular disorders | Systematic Assessment |
| ||
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| TACHYCARDIA | Cardiac disorders | Systematic Assessment |
| ||
| ABDOMINAL DISTENSION | Gastrointestinal disorders | Systematic Assessment |
| ||
| ALOPECIA | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| AMNESIA | Nervous system disorders | Systematic Assessment |
| ||
| BURSITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| DECREASED APPETITE | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| NECK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| SYNCOPE | Nervous system disorders | Systematic Assessment |
| ||
| TOOTH ABSCESS | Infections and infestations | Systematic Assessment |
| ||
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| CONTUSION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| IRRITABILITY | General disorders | Systematic Assessment |
| ||
| PULMONARY MASS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY TRACT INFECTION | Infections and infestations | Systematic Assessment |
| ||
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| SUICIDAL IDEATION | Psychiatric disorders | Systematic Assessment |
| ||
| ABNORMAL DREAMS | Psychiatric disorders | Systematic Assessment |
| ||
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | Cardiac disorders | Systematic Assessment |
| ||
| COGNITIVE DISORDER | Nervous system disorders | Systematic Assessment |
| ||
| CONFUSIONAL STATE | Psychiatric disorders | Systematic Assessment |
| ||
| EYE INFECTION | Infections and infestations | Systematic Assessment |
| ||
| HERPES ZOSTER | Infections and infestations | Systematic Assessment |
| ||
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | Systematic Assessment |
| ||
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| URINARY INCONTINENCE | Renal and urinary disorders | Systematic Assessment |
| ||
| DEEP VEIN THROMBOSIS | Vascular disorders | Systematic Assessment |
| ||
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| LYMPHOPENIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| PNEUMONIA | Infections and infestations | Systematic Assessment |
| ||
| ANAEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| ASTHENIA | General disorders | Systematic Assessment |
| ||
| ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
| ||
| DRY MOUTH | Gastrointestinal disorders | Systematic Assessment |
| ||
| EAR DISCOMFORT | Ear and labyrinth disorders | Systematic Assessment |
| ||
| ERYTHEMA | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| HAEMATURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| MEMORY IMPAIRMENT | Nervous system disorders | Systematic Assessment |
| ||
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| SALIVARY HYPERSECRETION | Gastrointestinal disorders | Systematic Assessment |
| ||
| TOOTH INFECTION | Infections and infestations | Systematic Assessment |
| ||
| WRIST FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Oakes, PhD | University of Rochester Medical Center, Department of Biostatistics and Computational Biology | 5852752405 | david_oakes@urmc.rochester.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2017 | Nov 25, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017275 | Isradipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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