Phase 3
N=529
Fixed-Dose Trial in Early Parkinson's Disease (PD)
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT04201093 ↗Enrolled (actual)
529
Serious AEs
4.7%
Results posted
Jul 2025
Primary outcome: Primary: Change From Baseline in the MDS-UPDRS Parts II and III Combined Score — 1.8; -9.7; -10.2 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tavapadon (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the MDS-UPDRS Parts II and III Combined Score |
-1.2; -4.4; -4.7; -2.2; -6.9; -6.7 | <0.0001 sig |
| SECONDARY Change From Baseline in the MDS-UPDRS Part II Score |
0.9; -1.6; -1.7 | <0.0001 sig |
| SECONDARY Percentage of Responders With a Score of "Much Improved" or "Very Much Improved" on PGIC |
18; 60; 52 | <0.0001 sig |
| SECONDARY Change From Baseline in the MDS-UPDRS Parts II and III Combined Score |
-1.2; -4.4; -4.7; -2.2; -6.9; -6.7 | <0.0001 sig |
| SECONDARY Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score |
-1.2; -3.9; -4.0; -2.6; -6.4; -6.2 | <0.0001 sig |
| SECONDARY Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score |
0.0; 0.6; 0.7; -0.4; 0.5; 0.4 | 0.4822 |
| SECONDARY Change From Baseline in the CGI-S Score |
0.0; -0.1; 0.0; 0.0; -0.1; -0.1 | <0.0001 sig |
| SECONDARY Change From Baseline in the CGI-I Score |
3.8; 3.4; 3.4; 3.8; 3.2; 3.3 | <0.0001 sig |
| SECONDARY Change From Baseline in the PGIC Score |
3.7; 3.5; 3.4; 3.8; 3.2; 3.2 | <0.0001 sig |
| SECONDARY Change From Baseline in the Epworth Sleepiness Scale (ESS) |
-0.2; -0.3; -0.5 | 0.6047 |
| SECONDARY Change From Baseline in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) |
-2.1; -2.2; -2.4 | 0.8516 |
| SECONDARY Columbia-Suicide Severity Rating Scale (C-SSRS) |
3; 3; 3; 0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
100; 142; 139 | — |
Summary
The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.
Eligibility Criteria
Key Inclusion Criteria
- Male and female participants aged 40 to 80 years, inclusive, at the time of signing the informed consent form (ICF)
- Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment
- Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
- Participants with a diagnosis of PD that is consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria
- Participants with modified Hoehn and Yahr stage 1, 1.5, or 2
- Participants with disease duration (from time of diagnosis) of less than ( =2 and Part III score >=10 at the Screening Visit and at the Baseline Visit
- Participants with early PD who, in the opinion of the investigator, require pharmacologic intervention for disease management
- Participants who are treatment naïve or have a history of prior incidental treatment with dopaminergic agents (including Levodopa [L-Dopa] and dopamine receptor agonist medications) for 90 days before the Baseline Visit and the dosage will remain stable for the duration of the trial (i.e, no change in the MAO-B inhibitor dose is permitted during the trial)
- Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial.
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 Columbia-Suicide Severity Rating Scale (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 v
Data sourced from ClinicalTrials.gov (NCT04201093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.