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Phase 3 N=529 Randomized Double-blind Treatment

Fixed-Dose Trial in Early Parkinson's Disease (PD)

Parkinson Disease

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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