Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002951-40 | EudraCT Number |
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The purpose of this study is to assess the effect of tavapadon on the change from baseline in total daily hours of "on" time without troublesome dyskinesia in L-Dopa-treated participants with Parkinson's Disease (PD) who are experiencing motor fluctuations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tavapadon | Experimental | Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tavapadon | Drug | Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total "on" time without troublesome dyskinesia will be assessed and reported at endpoint. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary) | The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total daily "Off" time will be assessed and reported at endpoint. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pheonix, Arizona | Phoenix | Arizona | 85004 | United States | ||
| Little Rock, Arkansas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41860544 | Derived | Fernandez HH, Isaacson SH, Hauser RA, Agarwal P, Ondo W, Park A, Kremens D, Leoni M, Duvvuri S, Combs C, Koenig E, Chang I, Pastino G, Tringali S, Golonski N, Sanchez R, Harmer L, Boiser J, Zadikoff C, Mari Z. Tavapadon as Adjunctive Treatment for Parkinson Disease: The TEMPO-3 Randomized Clinical Trial. JAMA Neurol. 2026 May 1;83(5):442-451. doi: 10.1001/jamaneurol.2026.0577. |
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In this Phase 3, Double-Blind study, a total of 368 subjects with Parkinson's Disease(PD) were be randomized in a 1:1 ratio to receive Tavapadon (5 mg to 15 mg) or Placebo once daily (QD) for 27 Weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks. Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks. |
| FG001 | Tavapadon |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 6, 2023 | Feb 4, 2025 |
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| Placebo | Drug | Participants will receive placebo matching to tavapadon QD orally for 27 weeks. |
|
| Week 26 |
| Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total "on" time without troublesome dyskinesia will be assessed and reported at different time points. | Week 2, 5, 8, 11, 14, 18, 22, and 26 |
| Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary) | The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total daily "Off" time will be assessed and reported at different time points. | Week 2, 5, 8, 11, 14, 18, 22, and 26 |
| Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual Score | The MDS-UPDRS rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. | Week 26 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Fountain Valley, California | Fountain Valley | California | 92708 | United States |
| Fresno, California | Fresno | California | 93710 | United States |
| Long beach, California | Long Beach | California | 90806 | United States |
| Los Angeles, California | Los Angeles | California | 90048 | United States |
| Pasadena, California | Pasadena | California | 91105 | United States |
| Reseda, California | Reseda | California | 91335 | United States |
| Denver, Colorado | Denver | Colorado | 80210 | United States |
| Englewood, Colorado | Englewood | Colorado | 80113 | United States |
| Adventura, Florida | Adventura | Florida | 33180 | United States |
| Atlantis, Florida | Atlantis | Florida | 33462 | United States |
| Boca Raton, Florida | Boca Raton | Florida | 33486 | United States |
| Boca Raton, Florida | Boca Raton | Florida | 33487 | United States |
| Coral Springs, Florida | Coral Springs | Florida | 33067 | United States |
| Hallandale Beach, Florida | Hallandale | Florida | 33009 | United States |
| Maitland, Florida | Maitland | Florida | 32751 | United States |
| Ocala, Florida | Ocala | Florida | 34470 | United States |
| Port Charlotte, Florida | Port Charlotte | Florida | 33980 | United States |
| Port Orange, Florida | Port Orange | Florida | 32127 | United States |
| Tampa, Florida | Tampa | Florida | 33615 | United States |
| Winter Park, Florida | Winter Park | Florida | 32792 | United States |
| Augusta, Georgia | Augusta | Georgia | 30912 | United States |
| Chicago, Illinois | Chicago | Illinois | 60612 | United States |
| Elk Grove Village, Illinois | Elk Grove Village | Illinois | 60007 | United States |
| Kansas City, Kansas | Kansas City | Kansas | 66160 | United States |
| Lexington, Kentucky | Lexington | Kentucky | 40536 | United States |
| Scarborough, Maine | Scarborough | Maine | 04074 | United States |
| Boston, Massachusettes | Boston | Massachusetts | 02215 | United States |
| Boston Neuro Research Center | North Dartmouth | Massachusetts | 02747 | United States |
| Farmington Hills, Michigan | Farmington Hills | Michigan | 48334 | United States |
| West Bloomfield, Michigan | West Bloomfield | Michigan | 48322 | United States |
| Saint Louis, Missouri | St Louis | Missouri | 63110 | United States |
| Las Vegas, Nevada | Las Vegas | Nevada | 89106 | United States |
| Las Vegas, Nevada | Las Vegas | Nevada | 89118 | United States |
| Syracuse, New York | Syracuse | New York | 13210 | United States |
| Asheville, North Carolina | Asheville | North Carolina | 28806 | United States |
| Cincinnati, Ohio | Cincinnati | Ohio | 45212 | United States |
| Cleveland, Ohio | Cleveland | Ohio | 44195 | United States |
| Columbus, Ohio | Columbus | Ohio | 43221 | United States |
| Dayton, Ohio | Dayton | Ohio | 45459 | United States |
| Toledo, Ohio | Toledo | Ohio | 43614 | United States |
| Memphis, Tennessee | Memphis | Tennessee | 38157 | United States |
| Cypress, Texas | Cypress | Texas | 77429 | United States |
| Georgetown, Texas | Georgetown | Texas | 78628 | United States |
| Houston, Texas | Houston | Texas | 77030 | United States |
| Lubbock, Texas | Lubbock | Texas | 79410 | United States |
| Round Rock, Texas | Round Rock | Texas | 78681 | United States |
| Burlington, Vermont | Burlington | Vermont | 05401 | United States |
| Richmond, Virginia | Richmond | Virginia | 23229 | United States |
| Richmond, Virginia | Richmond | Virginia | 23233 | United States |
| Virginia Beach, Virginia | Virginia Beach | Virginia | 23456 | United States |
| Kirkland, Washington | Kirkland | Washington | 98034 | United States |
| Spokane, Washington | Spokane | Washington | 99202 | United States |
| Clayton VIC | Clayton | Clayton VIC | 3168 | Australia |
| Erina, New South Wales | Erina | New South Wales | 2250 | Australia |
| Kogarah, New South Wales | Kogarah | New South Wales | 2217 | Australia |
| Woolloongabba, Queensland | Woolloongabba | Queensland | 4102 | Australia |
| Parkville, Victoria | Parkville | Victoria | 3050 | Australia |
| Pleven, Bulgaria | Pleven | 5800 | Bulgaria |
| Pleven | Pleven | 5800 | Bulgaria |
| Multiprofile Hospital, Sofia | Sofia | 1113 | Bulgaria |
| Sofia | Sofia | 1142 | Bulgaria |
| Sofia | Sofia | 1407 | Bulgaria |
| DCC Neoclinic | Sofia | 1408 | Bulgaria |
| Sofia | Sofia | 1431 | Bulgaria |
| Ottawa, Ontario | Ottawa | Ontario | K1Y4E9 | Canada |
| Toronto, Ontario | Toronto | Ontario | M5T 2S8 | Canada |
| Chocen | Choceň | Chocen | 56501 | Czechia |
| Prague, Czech Republic | Prague | Czech Republic | 150 00 | Czechia |
| Prague, | Prague | 100 00 | Czechia |
| Prague, | Prague | 160 00 | Czechia |
| Rychnov nad Kněžnou | Rychnov nad Kněžnou | 516 01 | Czechia |
| Creteil, | Créteil | Creteil | 94010 | France |
| Boulevard Pinel, Bron | Bron | 69500 | France |
| Nantes CEDEX 1 | Nantes | 44093 | France |
| Nîmes cedex | Nîmes | 30029 | France |
| Strasbourg | Strasbourg | 67098 | France |
| Toulouse Cedex 9 | Toulouse | 31059 | France |
| Muenster | Münster | Muenster | 48149 | Germany |
| Bad Homburg | Bad Homburg | 61348 | Germany |
| Berlin | Berlin | 12163 | Germany |
| Bochum | Bochum | 44791 | Germany |
| Brandenburg, Germany | Brandenburg | 14547 | Germany |
| Duesseldorf, | Düsseldorf | 40225 | Germany |
| Gera | Gera | 07551 | Germany |
| Haag in Oberbayern | Haag in Oberbayern | 83527 | Germany |
| Klinikum rechts der Isar der TU München | Munich | 81675 | Germany |
| Muenchen | München | 81377 | Germany |
| Stadtroda | Stadtroda | 07646 | Germany |
| Gyor, | Győr | Gyor | 9024 | Hungary |
| Budapest | Budapest | 1135 | Hungary |
| Pecs | Pécs | 7623 | Hungary |
| Szeged | Szeged | 6725 | Hungary |
| Ashkelon | Ashkelon | 7830406 | Israel |
| Haifa | Haifa | 3109601 | Israel |
| Jerusalem | Jerusalem | 91120 | Israel |
| Petah Tiqva | Petah Tikva | 49100 | Israel |
| Shoham | Shoham | 6083531 | Israel |
| Tel Aviv | Tel Aviv | 6100000 | Israel |
| Ancona | Ancona | 60126 | Italy |
| Cassino | Cassino | 03043 | Italy |
| Milano | Milan | 20132 | Italy |
| Padova | Padova | 35128 | Italy |
| Pisa | Pisa | 56126 | Italy |
| Rome | Rome | 00133 | Italy |
| Rome | Rome | 00163 | Italy |
| Rome | Rome | 00179 | Italy |
| Rozzano Milano | Rozzano | 20089 | Italy |
| Torino | Torino | 10126 | Italy |
| Cracow | Krakow | Cracow | 31-505 | Poland |
| Krakow | Krakow | Krakow | 30-539 | Poland |
| Bydgoszcz, Kujawsko-Pomorskie | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-163 | Poland |
| Siemianowice Slaskie | Siemianowice Śląskie | Siemianowice Slaskie | 41-100 | Poland |
| Katowice | Katowice | 40-097 | Poland |
| Katowice | Katowice | 40-123 | Poland |
| Kraków | Krakow | 30-510 | Poland |
| Krakow | Krakow | 30-721 | Poland |
| Lublin | Lublin | 20-016 | Poland |
| Centrum Medyczne Hope Clinic Sebastian Szklener | Lublin | 20-701 | Poland |
| Warsaw | Warsaw | 01-868 | Poland |
| Singua | Warsaw | 02-777 | Poland |
| Lodz | Lodz | Łódź Voivodeship | 90-640 | Poland |
| Belgrade, Serbia | Belgrade | 11000 | Serbia |
| Belgrade, | Belgrade | 11000 | Serbia |
| Belgrade | Belgrade | 11000 | Serbia |
| Belgrade, Kragujevac | Belgrade | 11060 | Serbia |
| Elche | Elche | Alicante | 03203 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08041 | Spain |
| Barcelona | Barcelona | 08190 | Spain |
| San Sebastian | Donostia / San Sebastian | 20009 | Spain |
| Madrid | Madrid | 28006 | Spain |
| Madrid, Spain | Madrid | 28036 | Spain |
| Pamplona | Pamplona | 31008 | Spain |
| Sevilla | Seville | 41013 | Spain |
| Terrassa | Terrassa | 08222 | Spain |
| Valencia | Valencia | 46026 | Spain |
| Zaporiizhzhya | Zaporizhzhya | Zaporiizhzhya | 69600 | Ukraine |
| Zaporozhya | Zaporizhzhya | Zaporozhya | 69000 | Ukraine |
| Zaporozhya | Zaporizhzhya | Zaporozhya | 69035 | Ukraine |
| Dnipro | Dnipro | 49027 | Ukraine |
| Kharkiv | Kharkiv | 61058 | Ukraine |
| Kiev | Kiev | 04114 | Ukraine |
| Lviv | Lviv | 79010 | Ukraine |
| Vinnitsa | Vinnitsa | 21050 | Ukraine |
Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Includes all enrolled subjects that received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks. Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks. |
| BG001 | Tavapadon | Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks. Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks. |
| BG002 | 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: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| ON Time (hours) Without Troublesome Dyskinesia at Baseline | Population includes subjects who received at least one dose of study drug and had available data for analysis. | Mean | Standard Deviation | hours |
| ||||||||||||||
| OFF Time (hours) at Baseline | Population includes subjects who received at least one dose of study drug and had available data for analysis. | Mean | Standard Deviation | hours |
| ||||||||||||||
| Movement Disorder Society - Unified Parkinson's Disease Rating Score at Baseline (Parts I, II, III) | The MDS-UPDRS rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| 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 From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total "on" time without troublesome dyskinesia will be assessed and reported at endpoint. | Population includes subjects who received at least one dose of study drug and had available data for analysis. | Posted | Least Squares Mean | Standard Error | hours | Week 26 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary) | The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total daily "Off" time will be assessed and reported at endpoint. | Population includes subjects who received at least one dose of study drug and had available data for analysis. | Posted | Least Squares Mean | Standard Error | hours | Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total "on" time without troublesome dyskinesia will be assessed and reported at different time points. | Population includes subjects who received at least one dose of study drug and had available data for analysis. | Posted | Least Squares Mean | Standard Error | hours | Week 2, 5, 8, 11, 14, 18, 22, and 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary) | The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total daily "Off" time will be assessed and reported at different time points. | Population includes subjects who received at least one dose of study drug and had available data for analysis. | Posted | Least Squares Mean | Standard Error | hours | Week 2, 5, 8, 11, 14, 18, 22, and 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual Score | The MDS-UPDRS rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. | Population includes subjects who received at least one dose of study drug and had available data for analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 26 |
|
All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
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 | Placebo | Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks. Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks. | 0 | 255 | 14 | 255 | 90 | 255 |
| EG001 | Tavapadon | Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks. Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks. | 1 | 252 | 17 | 252 | 130 | 252 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CHRONIC | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| GLAUCOMA | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| BRONCHITIS BACTERIAL | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| EYE INFECTION | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| INFECTIVE ANEURYSM | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| LYME DISEASE | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| SUBACUTE ENDOCARDITIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC DISORDER | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| RHEUMATIC DISORDER | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| B-CELL SMALL LYMPHOCYTIC LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| PANCREATIC CARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| COLLOID BRAIN CYST | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| MIDDLE CEREBRAL ARTERY STROKE | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ON AND OFF PHENOMENON | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ANXIETY DISORDER | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| HALLUCINATION, VISUAL | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DYSKINESIA | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DYSTONIA | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| HALLUCINATION, VISUAL | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 11, 2024 | Feb 4, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D000080874 | Synucleinopathies |
Not provided
Not provided
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| Part II |
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| Part III |
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| Units | Counts |
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