Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients
NCT03162874 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157
Last updated 2020-03-17
Summary
This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)
Conditions
- Parkinson Disease
Interventions
- DRUG
-
Placebo oral capsule
BID
- DRUG
-
PXT002331 - dose 1
Oral
- DRUG
-
PXT002331 - dose 2
Oral
Sponsors & Collaborators
-
Prexton Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-04
- Primary Completion
- 2020-02-19
- Completion
- 2020-03-02
Countries
- Austria
- France
- Germany
- Italy
- Spain
- United Kingdom
Study Locations
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