Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5U01NS043128-12 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and futility.
Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but no more than 8 months, will be randomized to one of two dosages of oral pioglitazone (15 mg and 45 mg) or matching placebo.
The study will measure disease progression by the change in total Unified Parkinson's Disease Rating Scale (UPDRS) score between the baseline visit and 44 weeks.
A Multi-Center, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early Parkinson's Disease (PD). The patient population has early stage PD (< 5 years from diagnosis), must be treated with 1 mg/day of rasagiline or 10 mg/day of selegiline for at least 8 weeks but not more than 8 months prior to enrollment.
The primary objective of this clinical trial is to assess the futility of pioglitazone on PD disease progression as measured by the change in total UPDRS score between the baseline visit and 44 weeks. The secondary objectives of the study are to collect additional efficacy and safety/tolerability data to be used in planning a subsequent Phase III trial of pioglitazone in early, treated PD. Measures of cognition, mood and blood- and urine-based biomarkers will also be explored. Subjects in this trial are randomly assigned in a 1:1:1 ratio to one of three study arms: 15 mg, 45 mg or placebo.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg pioglitazone | Experimental | 15 mg pioglitazone |
|
| 45 mg pioglitazone | Experimental | 45 mg pioglitazone |
|
| Matching Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to 44 Weeks | Change in total UPDRS score from baseline to 44 weeks (in subjects treated with rasagiline 1 mg/day or selegiline 10 mg/day). The Total UPDRS is the sum of parts I, II, and III. The possible range of the total UPDRS is from 0-176. Higher values indicate worse outcomes. The change is 44 weeks - baseline. | 44 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ambulatory Capacity From Baseline to 44 Weeks | This is the sum of the 5 UPDRS questions regarding ambulatory capacity: falling, freezing, walking, gait, postural stability. Ambulatory Capacity is calculated as the sum of items 13-15, 29, 30 of the Unified Parkinson's Disease Rating Scale (UPDRS). It ranges from 0-20. Higher scores are worse. Change is 44 weeks - baseline. | 44 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tanya Simuni, MD | Northwestern University | Study Director |
| Karl Kieburtz, MD MPH | University of Rochester | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Alabama at Birmingham | Birmingham | Alabama | 35294-0017 | United States | ||
| Barrow Neurological Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26116315 | Result | NINDS Exploratory Trials in Parkinson Disease (NET-PD) FS-ZONE Investigators. Pioglitazone in early Parkinson's disease: a phase 2, multicentre, double-blind, randomised trial. Lancet Neurol. 2015 Aug;14(8):795-803. doi: 10.1016/S1474-4422(15)00144-1. Epub 2015 Jun 23. | |
| 25227476 | Derived | Carta AR, Simuni T. Thiazolidinediones under preclinical and early clinical development for the treatment of Parkinson's disease. Expert Opin Investig Drugs. 2015 Feb;24(2):219-27. doi: 10.1517/13543784.2015.963195. Epub 2014 Sep 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 15 mg Pioglitazone | 15 mg pioglitazone Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo 44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| placebo | Drug | Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule. |
|
| Change in Schwab and England Scale From Baseline to 44 Weeks | The modified Schwab and England Activities of Daily Living is a single question ranging from 0-100% with anchors for each 10% interval. Higher scores are better (100% completely independent- 0% vegetative). | 44 weeks |
| Change in Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 44 Weeks | The Parkinson's Disease Questionnaire (PDQ-39) is a short, 39 item measure of quality of life in subjects with Parkinson's disease. The questionnaire covers 8 aspects of quality of life: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort. The total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life. | 44 weeks |
| Change in the Mattis Dementia Rating Scale (DRS-2)From Baseline to 44 Weeks | The Mattis dementia rating scale is a psychometric instrument designed to assess the extent and nature of dementia. Mattis Dementia Rating scale (DRS-2) raw score is the sum of 5 raw sub-scores (attention has possible 37 points, initiation/perseveration has possible 37 points, construction has possible 6 points, conceptualization has possible 39 points, memory has possible 25 points). Total range is 0-144. Higher scores are better. | 44 weeks |
| Change in the 15-item Geriatric Depression Scale (GDS-15)From Baseline to 44 Weeks | The Geriatric Depression Scale - 15 is a short 15 yes or no question instrument for assessing depression in the elderly. It has been found to be particularly useful in assessing depression in Parkinson's Disease. A score of 0 to 5 is normal. A score greater than 5 suggests depression. | 44 weeks |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| The Parkinson's & Movement Disorder Institute | Fountain Valley | California | 92708 | United States |
| University of Southern California | Los Angeles | California | 90083 | United States |
| University of California San Fransisco | San Francisco | California | 94143-0114 | United States |
| Univeristy of Colorado Denver | Aurora | Colorado | 80045 | United States |
| University of Florida | Gainsville | Florida | 32610 | United States |
| University of Florida, Jacksonville | Jacksonville | Florida | 32209 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30329 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | 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 Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| LSU Health Science Center Shreveport | Shreveport | Louisiana | 71103 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287-0875 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-5316 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| Struthers Parkinson's Center | Golden Valley | Minnesota | 55427 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203-2098 | United States |
| North Shore - LIJ Health System | Manhasset | New York | 11030 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239-3098 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29401 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9036 | United States |
| University of Vermont | Burlington | Vermont | 05405 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| FG001 | 45 mg Pioglitazone | 45 mg pioglitazone Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo 44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks. |
| FG002 | Matching Placebo | Placebo placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 15 mg Pioglitazone | 15 mg pioglitazone Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo 44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks. |
| BG001 | 45 mg Pioglitazone | 45 mg pioglitazone Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo 44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks. |
| BG002 | Matching Placebo | Placebo placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Years of education | Mean | Standard Deviation | years |
| |||||||||||||||
| Right-handed | Number | participants |
| ||||||||||||||||
| Duration of PD symptoms (years) | Mean | Standard Deviation | years |
| |||||||||||||||
| Time since PD diagnosis (years) | Mean | Standard Deviation | years |
| |||||||||||||||
| Total Unified Parkinson's Disease Rating Scale (UPDRS) | The Total UPDRS is the sum of parts I, II, and III. The possible range of the total UPDRS is from 0-176. Higher values indicate worse outcomes. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| UPDRS mental | The UPDRS mental score is the sum of the questions in part I. The possible range of the UPDRS mental is from 0-16. Higher values indicate worse outcomes. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| UPDRS motor | The UPDRS motor score is the sum of the questions in part III. The possible range of the UPDRS motor is from 0-108. Higher values indicate worse outcomes. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| UPDRS ADL | The UPDRS ADL score is the sum of the questions in part II (activities of daily living). The possible range of the UPDRS ADL is from 0-52. Higher values indicate worse outcomes. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Ambulatory capacity | Ambulatory Capacity is calculated as the sum of items 13-15, 29, 30 of the Unified Parkinson's Disease Rating Scale (UPDRS). It ranges from 0-20. Higher scores are worse. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Schwab and England Activities of Daily Living scale (SEADL) | The modified Schwab and England Activities of Daily Living is a single question ranging from 0-100% with anchors for each 10% interval. Higher scores are better (100% completely independent- 0% vegetative). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Parkinson's Disease Questionnaire 39 (PDQ-39) Summary Index | The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality. The total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Geriatric Depression Scale (GDS) | Short version. 15 questions. A score of 0 to 5 is normal. A score greater than 5 suggests depression. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Mattis-Dementia Rating scale | Mattis Dementia Rating scale (DRS-2) raw score is the sum of 5 raw sub-scores (attention has possible 37 points, initiation/perseveration has possible 37 points, construction has possible 6 points, conceptualization has possible 39 points, memory has possible 25 points). Total range is 0-144. Higher scores are better. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| rasagiline/selegiline use | Proportion of patients on stable regimen of either 1 mg/day rasagiline or 10 mg/day selegiline at baseline. | Number | participants |
|
| 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 | Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to 44 Weeks | Change in total UPDRS score from baseline to 44 weeks (in subjects treated with rasagiline 1 mg/day or selegiline 10 mg/day). The Total UPDRS is the sum of parts I, II, and III. The possible range of the total UPDRS is from 0-176. Higher values indicate worse outcomes. The change is 44 weeks - baseline. | Posted | Mean | Standard Error | units on a scale | 44 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in Ambulatory Capacity From Baseline to 44 Weeks | This is the sum of the 5 UPDRS questions regarding ambulatory capacity: falling, freezing, walking, gait, postural stability. Ambulatory Capacity is calculated as the sum of items 13-15, 29, 30 of the Unified Parkinson's Disease Rating Scale (UPDRS). It ranges from 0-20. Higher scores are worse. Change is 44 weeks - baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | 44 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Schwab and England Scale From Baseline to 44 Weeks | The modified Schwab and England Activities of Daily Living is a single question ranging from 0-100% with anchors for each 10% interval. Higher scores are better (100% completely independent- 0% vegetative). | Posted | Mean | 95% Confidence Interval | units on a scale | 44 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 44 Weeks | The Parkinson's Disease Questionnaire (PDQ-39) is a short, 39 item measure of quality of life in subjects with Parkinson's disease. The questionnaire covers 8 aspects of quality of life: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort. The total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life. | Posted | Mean | 95% Confidence Interval | units on a scale | 44 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in the Mattis Dementia Rating Scale (DRS-2)From Baseline to 44 Weeks | The Mattis dementia rating scale is a psychometric instrument designed to assess the extent and nature of dementia. Mattis Dementia Rating scale (DRS-2) raw score is the sum of 5 raw sub-scores (attention has possible 37 points, initiation/perseveration has possible 37 points, construction has possible 6 points, conceptualization has possible 39 points, memory has possible 25 points). Total range is 0-144. Higher scores are better. | Posted | Mean | 95% Confidence Interval | units on a scale | 44 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in the 15-item Geriatric Depression Scale (GDS-15)From Baseline to 44 Weeks | The Geriatric Depression Scale - 15 is a short 15 yes or no question instrument for assessing depression in the elderly. It has been found to be particularly useful in assessing depression in Parkinson's Disease. A score of 0 to 5 is normal. A score greater than 5 suggests depression. | Posted | Mean | 95% Confidence Interval | units on a scale | 44 weeks |
|
All events during study period (defined as from signing consent to conclusion of study participation 44 weeks).
Adverse event data was elicited by asking an open ended question "What unusual symptoms or medical problems have you experienced since the last visit?"
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 | 15 mg Pioglitazone | 15 mg pioglitazone Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo 44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks. | 6 | 72 | 63 | 72 | ||
| EG001 | 45 mg Pioglitazone | 45 mg pioglitazone Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo 44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks. | 9 | 67 | 51 | 67 | ||
| EG002 | Matching Placebo | Placebo placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule. | 3 | 71 | 59 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tanya Simuni, MD | Northwestern University | TSimuni@nm.org |
| 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 |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Females |
|
| Racial/Ethnic Minority |
|
| No |
|
| selegiline use |
|
| OG002 | Matching Placebo | Placebo placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule. |
|
|
| Matching Placebo |
Placebo placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule. |
|
|
| OG002 | Matching Placebo | Placebo placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule. |
|
|
| OG002 | Matching Placebo | Placebo placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule. |
|
|
| OG002 | Matching Placebo | Placebo placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule. |
|
|