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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002950-22 | EudraCT Number |
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The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tavapadon | Experimental | Participants will receive tavapadon tablet titrated up to 15 milligram (mg) once daily (QD) orally for 27 weeks. |
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| Placebo | Placebo Comparator | Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tavapadon | Drug | Participants will be randomized to receive tavapadon 5 mg QD to 15 mg QD tablet once daily orally for 27 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score | The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (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. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the MDS-UPDRS Part II Score | The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (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. A negative change from baseline represents an improvement in motor function. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supra nuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or post stroke parkinsonism).
Participants with a history of nonresponse or insufficient response to L-Dopa at therapeutic dosages.
Participants with a history or current diagnosis of a clinically significant impulse control disorder (Disruptive, Impulse Control, and Conduct Disorder per DSM-5).
Participants with the presence of or history of brain tumor, hospitalization for severe head trauma, epilepsy (as defined by the International League Against Epilepsy), or seizures.
Participants with a history of psychosis or hallucinations within the previous 12 months.
Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide.
Participants with substance abuse or dependence disorder, including alcohol, benzodiazepines, and opioids, but excluding nicotine, within the past 6 months (180 days).
Participants with dementia or cognitive impairment that, in the judgement of the investigator, would exclude the participant from understanding the ICF or participating in the trial.
Participants with any condition that could possibly affect drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding).
Participants who have a positive result for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibodies at screening.
Participants with a history of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical intervention; second- or third-degree atrioventricular block; sick sinus syndrome; severe or unstable angina; or congestive heart failure within the last 12 months. A recent (less than or equal to [<=] 12 months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control.
Participants with a history of neuroleptic malignant syndrome.
Participants who are currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration).
Participants with a positive urine drug screen for illicit drugs are excluded and may not be retested or rescreened. Participants with a positive urine drug screen resulting from use of marijuana (any Tetrahydrocannabinol [THC]-containing product), prescription, or over-the-counter medications or products that, in the investigator's documented opinion, do not signal a clinical condition that would impact the safety of the participant or interpretation of the trial results may continue evaluation for the trial following consultation and approval by the medical monitor.
Participants with a Montreal Cognitive Assessment (MoCA) score <26.
Participants with clinically significant orthostatic hypotension (eg, syncope).
Participants with a 12-lead ECG demonstrating a QTcF interval >450 msec.
Participants with moderate or severe renal impairment (creatinine clearance as estimated by Cockcroft-Gault formula <30 mL/min or on dialysis).
Participants with any of the following abnormalities in clinical laboratory tests at the Screening Visit, as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fresno, California | Fresno | California | 93710 | United States | ||
| Boca Raton, Florida |
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In this Phase 3, Double-Blind study, a total of 304 participants with Parkinson's Disease (PD) were randomized in a 1:1 ratio to either Placebo, or tavapadon 5 mg to 15 mg once daily (QD) for 27 Weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks. |
| FG001 | Tavapadon | Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks. |
| 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 | Jul 6, 2023 | Sep 19, 2025 |
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| Placebo | Drug | Participants will receive placebo matching to tavapadon QD orally for 27 weeks. |
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| Week 26 |
| Percentage of Responders With "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (PGIC) | The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" was assessed. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome. | Week 26 |
| Change From Baseline in the MDS-UPDRS Parts II and III Combined Score | The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (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. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184. | Week 5, 8, 11, 14, 18, 22, 26, and 27 |
| Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score | The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (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. A negative change from baseline represents an improvement in motor function. Parts 1, 2, and 3 combined is the sum of Part 1, Part 2, and Part 3 scores at each assessment time for each participant. The combined score assesses 44 items with score range: 0-236. | Week 5, 8, 11, 14, 18, 22, 26, and 27 |
| Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score | The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (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. A negative change from baseline represents an improvement in motor function. | Week 5, 8, 11, 14, 18, 22, 26, and 27 |
| Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score | The Global Impression - Severity of Illness (CGI-S) Score is a clinician's impression of a participant's severity of illness on a 7-point scale. Scores ranged from 1-7 on a scale of 1 (normal) to 7 (among the most extremely ill participants). Higher values represent a worse outcome. | Week 5, 8, 11, 14, 18, 22, 26, and 27 |
| Clinical Global Impression - Improvement (CGI-I) Score | The Clinical Global Impression - Improvement (CGI-I) Score is a clinician's impression of how much the participant's illness has improved or worsened relative to the baseline on a 7-point scale. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome. | Week 5, 8, 11, 14, 18, 22, 26, and 27 |
| Change From Baseline in the PGIC Score | The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" was assessed. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome. | Week 5, 8, 11, 14, 18, 22, 26, and 27 |
| Change From Baseline in the Epworth Sleepiness Scale (ESS) | The ESS is an 8-question, participant questionnaire that is intended to measure daytime sleepiness. It assesses the likelihood of dozing off or falling asleep in the following common situations: sitting and reading, sitting inactive in a public place as a passenger in a car for an hour or more without stopping for a break, lying down to rest when circumstances permit, sitting and talking to someone, sitting quietly after a meal without alcohol, and in a car while stopped for a few minutes in traffic or at a light. Each situation is rated on a 4-point (0-3) scale with scores ranging from 0 (would never nod off) to 3 (high chance of nodding off). Higher values represent a worse outcome. A negative change from baseline represents an improvement in daytime sleepiness. The total ESS score range was 0 - 24. | Week 26 |
| Change From Baseline in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) | QUIP-RS is a questionnaire for impulse-compulsive disorders in Parkinson's disease rating scale to assess impulse control disorders (ICD). The QUIP-RS has 4 primary questions that pertain to commonly reported thoughts, urges/ desires, and behaviors associated with ICDs, each of which is applied to 4 ICDs (compulsive gambling, buying, eating, sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). The QUIP-RS uses a 5-point Likert scale (score 0-4 [0 means "never" and 4 means "very often"] for each question) to gauge the frequency of behaviors. Scores for each ICD and related disorder range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112. A higher score indicating greater severity of symptoms. A negative change from baseline represents an improvement in ICDs. | Week 26 |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation (SI) categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide. | Week 27 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | From first dose of study drug until 190 days following last dose of study drug. |
| Boca Raton |
| Florida |
| 33487 |
| United States |
| Maitland, Florida | Maitland | Florida | 32751 | United States |
| Ocala, Florida | Ocala | Florida | 34470 | United States |
| Winter Park, Florida | Winter Park | Florida | 32792 | United States |
| Boston Neuro Research Center | North Dartmouth | Massachusetts | 02747 | United States |
| Albany, New York | Albany | New York | 12208 | United States |
| Syracuse, New York | Syracuse | New York | 13210 | United States |
| Cincinnati, Ohio | Cincinnati | Ohio | 45212 | United States |
| Cleveland, Ohio | Cleveland | Ohio | 44195 | United States |
| Memphis, Tennessee | Memphis | Tennessee | 38157 | United States |
| Cypress, Texas | Cypress | Texas | 77429 | 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 |
| Richmond, Virginia | Richmond | Virginia | 23229 | United States |
| Richmond, Virginia | Richmond | Virginia | 23233 | United States |
| Kirkland, Washington | Kirkland | Washington | 98034 | United States |
| Macquarie Park, New South Wales | Sydney | New South Wales | 2109 | Australia |
| Marseille, France | Marseille | France | 13385 | France |
| Nantes CEDEX 1 | Nantes | Nantes | 44093 | France |
| Toulouse Cedex 9 | Toulouse | Toulouse | 31059 | France |
| Bochum | Bochum | Bochum | 44791 | Germany |
| Gera | Gera | Gera | 07551 | Germany |
| Muenchen | München | Muenchen | 81377 | Germany |
| Berlin | Berlin | State of Berlin | 12163 | Germany |
| Budapest | Budapest | Budapest | 1135 | Hungary |
| Pecs | Pécs | Hungary | 7623 | Hungary |
| Tatabanya | Tatabánya | 2800 | Hungary |
| Cassino | Cassino | Cassino | 03043 | Italy |
| Milano | Milan | Milano | 20132 | Italy |
| Rome | Rome | Rome | 00133 | Italy |
| Rozzano Milano | Rozzano | 20089 | Italy |
| Torino | Torino | 10126 | Italy |
| Cracow | Krakow | Cracow | 31-505 | Poland |
| Katowice | Katowice | Katowice | 40-097 | Poland |
| Siemianowice Slaskie | Siemianowice Śląskie | Siemianowice Slaskie | 41-100 | Poland |
| Centrum Medyczne NEUROMED | Bydgoszcz | 85-163 | Poland |
| Centrum Medyczne Hope Clinic Sebastian Szklener | Lublin | 20-701 | Poland |
| Belgrade | Belgrade | Belgrade | 11000 | Serbia |
| Dongdaemun-gu, Seoul | Seoul | Dongdaemun-gu | 02447 | South Korea |
| Haeundae-gu, Busan | Busan | Haeundae-gu | 48108 | South Korea |
| Songpa-gu, Seoul | Seoul | Songpa-gu | 05505 | South Korea |
| Barcelona | Barcelona | Barcelona | 08035 | Spain |
| Móstoles, Madrid | Madrid | Madrid | 28938 | Spain |
| Zhongzheng, Taipei | Zhongzheng | Taipei | 100225 | Taiwan |
| Zhongzheng, Taipei | Zhongzheng | Taipei | 112062 | Taiwan |
| Ratchathewi, Bangkok | Ratchathewi | Bangkok | 10400 | Thailand |
| Khlong Luang, Pathum Thani | Khlong Luang | Changwat Pathum Thani | 12120 | Thailand |
| Nai Muang, Ubon Ratchathani | Nai Muang | Changwat Ubon Ratchathani | 34000 | Thailand |
| Kiev | Kiev | Kyiv City | 04114 | Ukraine |
| Lviv | Lviv | Lviv Oblast | 79010 | Ukraine |
| Vinnitsa | Vinnitsa | Vinnitsa | 21050 | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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ITT Population includes all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks. |
| BG001 | Tavapadon | Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks. |
| 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 | ||||||||||
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| 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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| MDS-UPDRS Score at Baseline (Parts II and III Combined) | The MDS-UPDRS rating tool was used to follow longitudinal course of Parkinson's Disease and consisted of 4 parts.Part 1:Non-motor aspects of experiences of daily living[13 items,Score range(SR):0-52];Part 2:Motor aspects of experiences of daily living(13 items,SR:0-52);Part 3:Motor examination(18 items,SR:0-132);Part 4:Motor complications(6 items,SR:0-24.Not collected).Each item has 0-4 rating on scale from 0(normal)-4(severe).Higher values represent a worse outcome.Parts 2 and 3 combined is the sum of Part 2 and Part 3 scores at each assessment time for each participant(31 items,SR:0-184). | Mean | Standard Deviation | units on a scale |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score | The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (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. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184. | mITT Population includes subjects who receive at least 1 dose of study drug and have both a baseline and at least 1 postbaseline MDS-UPDRS assessment, and had available data for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 26 |
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| Secondary | Change From Baseline in the MDS-UPDRS Part II Score | The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (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. A negative change from baseline represents an improvement in motor function. | mITT Population includes subjects who receive at least 1 dose of study drug and have both a baseline and at least 1 postbaseline MDS-UPDRS assessment, and had available data for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 26 |
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| Secondary | Percentage of Responders With "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (PGIC) | The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" was assessed. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome. | mITT Population includes subjects who receive at least 1 dose of study drug and have both a baseline and at least 1 postbaseline PGIC assessment, and had available data for analysis. | Posted | Count of Participants | Participants | Week 26 |
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| Secondary | Change From Baseline in the MDS-UPDRS Parts II and III Combined Score | The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (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. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184. | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Week 5, 8, 11, 14, 18, 22, 26, and 27 |
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| Secondary | Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score | The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (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. A negative change from baseline represents an improvement in motor function. Parts 1, 2, and 3 combined is the sum of Part 1, Part 2, and Part 3 scores at each assessment time for each participant. The combined score assesses 44 items with score range: 0-236. | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Week 5, 8, 11, 14, 18, 22, 26, and 27 |
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| Secondary | Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score | The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (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. A negative change from baseline represents an improvement in motor function. | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Week 5, 8, 11, 14, 18, 22, 26, and 27 |
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| Secondary | Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score | The Global Impression - Severity of Illness (CGI-S) Score is a clinician's impression of a participant's severity of illness on a 7-point scale. Scores ranged from 1-7 on a scale of 1 (normal) to 7 (among the most extremely ill participants). Higher values represent a worse outcome. | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Week 5, 8, 11, 14, 18, 22, 26, and 27 |
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| Secondary | Clinical Global Impression - Improvement (CGI-I) Score | The Clinical Global Impression - Improvement (CGI-I) Score is a clinician's impression of how much the participant's illness has improved or worsened relative to the baseline on a 7-point scale. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome. | mITT Population | Posted | Least Squares Mean | Standard Error | units on a scale | Week 5, 8, 11, 14, 18, 22, 26, and 27 |
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| Secondary | Change From Baseline in the PGIC Score | The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" was assessed. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome. | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Week 5, 8, 11, 14, 18, 22, 26, and 27 |
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| Secondary | Change From Baseline in the Epworth Sleepiness Scale (ESS) | The ESS is an 8-question, participant questionnaire that is intended to measure daytime sleepiness. It assesses the likelihood of dozing off or falling asleep in the following common situations: sitting and reading, sitting inactive in a public place as a passenger in a car for an hour or more without stopping for a break, lying down to rest when circumstances permit, sitting and talking to someone, sitting quietly after a meal without alcohol, and in a car while stopped for a few minutes in traffic or at a light. Each situation is rated on a 4-point (0-3) scale with scores ranging from 0 (would never nod off) to 3 (high chance of nodding off). Higher values represent a worse outcome. A negative change from baseline represents an improvement in daytime sleepiness. The total ESS score range was 0 - 24. | FAS population includes all randomized participants who received at least 1 dose of study drug, and had available data for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 26 |
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| Secondary | Change From Baseline in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) | QUIP-RS is a questionnaire for impulse-compulsive disorders in Parkinson's disease rating scale to assess impulse control disorders (ICD). The QUIP-RS has 4 primary questions that pertain to commonly reported thoughts, urges/ desires, and behaviors associated with ICDs, each of which is applied to 4 ICDs (compulsive gambling, buying, eating, sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). The QUIP-RS uses a 5-point Likert scale (score 0-4 [0 means "never" and 4 means "very often"] for each question) to gauge the frequency of behaviors. Scores for each ICD and related disorder range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112. A higher score indicating greater severity of symptoms. A negative change from baseline represents an improvement in ICDs. | FAS population includes all randomized participants who received at least 1 dose of study drug, and had available data for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 26 |
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| Secondary | Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation (SI) categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide. | FAS population | Posted | Count of Participants | Participants | Week 27 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | FAS Population | Posted | Count of Participants | Participants | From first dose of study drug until 190 days following last dose of study drug. |
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All-cause mortality were reported from enrollment until 4 weeks after the end of study. 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 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 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 received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks. | 0 | 153 | 2 | 153 | 59 | 153 |
| EG001 | Tavapadon | Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks. | 0 | 151 | 7 | 151 | 99 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPERCHROMIC ANAEMIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| FALL | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | MedDRA 27.1 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | MedDRA 27.1 | Systematic Assessment |
| |
| HEAD INJURY | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | MedDRA 27.1 | Systematic Assessment |
| |
| JOINT INJURY | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | MedDRA 27.1 | Systematic Assessment |
| |
| PRESYNCOPE | NERVOUS SYSTEM DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| REVERSIBLE CEREBRAL VASOCONSTRICTION SYNDROME | NERVOUS SYSTEM DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| DEPRESSION | PSYCHIATRIC DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| HYPERHIDROSIS | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| HYPERTENSION | VASCULAR DISORDERS | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | GASTROINTESTINAL DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| DIARRHOEA | GASTROINTESTINAL DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| DRY MOUTH | GASTROINTESTINAL DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| DYSPEPSIA | GASTROINTESTINAL DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | GASTROINTESTINAL DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| NAUSEA | GASTROINTESTINAL DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| SALIVARY HYPERSECRETION | GASTROINTESTINAL DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| VOMITING | GASTROINTESTINAL DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| ASTHENIA | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | MedDRA 27.1 | Systematic Assessment |
| |
| FATIGUE | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | MedDRA 27.1 | Systematic Assessment |
| |
| BRONCHITIS | INFECTIONS AND INFESTATIONS | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | INFECTIONS AND INFESTATIONS | MedDRA 27.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | INFECTIONS AND INFESTATIONS | MedDRA 27.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | INFECTIONS AND INFESTATIONS | MedDRA 27.1 | Systematic Assessment |
| |
| FALL | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | MedDRA 27.1 | Systematic Assessment |
| |
| DECREASED APPETITE | METABOLISM AND NUTRITION DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| ARTHRALGIA | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| BACK PAIN | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| PAIN IN EXTREMITY | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| DIZZINESS | NERVOUS SYSTEM DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| DYSGEUSIA | NERVOUS SYSTEM DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| HEADACHE | NERVOUS SYSTEM DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| PARAESTHESIA | NERVOUS SYSTEM DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| PARKINSON'S DISEASE | NERVOUS SYSTEM DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| SOMNOLENCE | NERVOUS SYSTEM DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| TREMOR | NERVOUS SYSTEM DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| ABNORMAL DREAMS | PSYCHIATRIC DISORDERS | MedDRA 27.1 | Systematic Assessment |
| |
| ANXIETY | PSYCHIATRIC DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| INSOMNIA | PSYCHIATRIC DISORDERS | MedDRA 27.1 | Systematic Assessment |
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| HYPOTENSION | VASCULAR DISORDERS | MedDRA 27.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 23, 2024 | Sep 19, 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
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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