A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)

AbbVie72 sites in 7 countries529 target enrollmentDecember 13, 2019

ConditionsParkinson Disease

InterventionsTavapadon Placebo

DrugsTavapadon Placebo

Overview

Phase: Phase 3
Intervention: Tavapadon
Conditions: Parkinson Disease
Sponsor: AbbVie
Enrollment: 529
Locations: 72
Primary Endpoint: Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 13, 2019

End Date

June 28, 2024

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

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 (\<) 3 years and disease progression in the 3 years before signing the ICF
•Participants with an MDS-UPDRS Part II score \>=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 \<3 months in total but not within 2 months of the Baseline Visit. Prior and concurrent use of monoamine oxidase B (MAO-B) inhibitors is permitted if use was initiated \>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.

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.

Arms & Interventions

Tavapadon 5 mg

Participants will receive tavapadon tablet titrated up to 5 milligram (mg) once daily (QD) orally for 27 weeks.

Intervention: Tavapadon

Tavapadon 15 mg

Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.

Intervention: Tavapadon

Placebo

Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in the MDS-UPDRS Parts II and III Combined Score

Time Frame: Week 26

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.

Secondary Outcomes

Change From Baseline in the MDS-UPDRS Part II Score(Week 26)
Percentage of Responders With a Score of "Much Improved" or "Very Much Improved" on PGIC(Week 26)
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score(Week 5, 8, 11, 14, 18, 22, 26, and 27)
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score(Week 5, 8, 11, 14, 18, 22, 26, and 27)
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score(Week 5, 8, 11, 14, 18, 22, 26, and 27)
Change From Baseline in the CGI-S Score(Week 5, 8, 11, 14, 18, 22, 26, and 27)
Change From Baseline in the CGI-I Score(Week 5, 8, 11, 14, 18, 22, 26, and 27)
Change From Baseline in the Epworth Sleepiness Scale (ESS)(Week 26)
Change From Baseline in the PGIC Score(Week 5, 8, 11, 14, 18, 22, 26, and 27)
Change From Baseline in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)(Week 26)
Columbia-Suicide Severity Rating Scale (C-SSRS)(Week 27)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From first dose of study drug until 190 days following last dose of study drug.)