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Tozadenant for Wearing-Off in Parkinson's Disease
NCT02453386Phase 3
Key facts
- Status
- Terminated
- Start
- Jul 2015
- Primary completion
- Jan 2018
- Countries
- 7
- Sponsor
- Biotie Therapies
- Modality
- Small Molecules
- Drugs
- tozadenant
- Conditions
- Parkinson's disease (PD)
01
Overview
Phase 3, randomised, double-blind trial of tozadenant in Parkinson's disease (PD) (3 arms), sponsored by Biotie Therapies. Primary endpoint: Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time. Started Jul 2015; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Tozadenant 60 mg BID
Tozadenant 60 mg BID + Placebo BID (total 4 tablets/day) + Levodopa
Tozadenant 120 mg BID
Tozadenant 60 mg (2 tablets) BID (total 4 tablets/day) + Levodopa
Placebo BID
Placebo (2 tablets) BID (total 4 tablets/day) + Levodopa
03
Who it enrols
Patients with idiopathic Parkinson's disease diagnosed for at least 3 years, on a stable regimen of levodopa for at least 12 months, and experiencing documented end-of-dose 'wearing-off'.
04
Endpoints
Primary
Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time
Secondary
Change in Good ON Time From Baseline to Week 24
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function
Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part III
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