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Tavapadon in early Parkinson's disease
NCT04223193Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2020
- Primary completion
- Oct 2024
- Countries
- 13
- Sponsor
- AbbVie Inc.
- Modality
- Small Molecules
- Drugs
- tavapadon
- Conditions
- Parkinson's disease (PD)
01
Overview
Phase 3, randomised, double-blind trial in Parkinson's disease (PD) comparing Tavapadon with Placebo (2 arms). Primary endpoint: Movement Disorder Society - Unified Parkinson's Disease Rating Scale Parts II and III Combined at 26 weeks. Started Jan 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Tavapadon
Tavapadon tablet titrated up to 15 mg QD orally for 27 weeks
Placebo
Placebo matching to tavapadon tablet QD orally for 27 weeks
03
Who it enrols
Adults aged 40-80 with early Parkinson's disease (modified Hoehn and Yahr stage 1-2, disease duration <3 years, MDS-UPDRS Part II ≥2 and Part III ≥10, MoCA ≥26), treatment naive or minimal prior dopaminergic exposure, requiring pharmacologic intervention, without atypical parkinsonism, impulse control disorders, psychosis, significant cognitive impairment, or major cardiovascular/hepatic/renal disease
04
Endpoints
Primary
Movement Disorder Society - Unified Parkinson's Disease Rating Scale Parts II and III Combined
Secondary
Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part II
Participant Global Impression of Change - Responders
Movement Disorder Society - Unified Parkinson's Disease Rating Scale Parts II and III Combined
Movement Disorder Society - Unified Parkinson's Disease Rating Scale Parts I, II and III Combined
Movement Disorder Society - Unified Parkinson's Disease Rating Scale Parts I, II and III Individual
Clinical Global Impression - Severity of Illness
Clinical Global Impression - Improvement
Participant Global Impression of Change
05
Results
Primary endpoints met
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