A Clinical Trial Investigating the Efficacy, Safety and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless).
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 300
Summary
- Conditions
- Parkinson's Disease
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Blinded Site Rater, Blinded CRAs, active drugs and matching placebo are identical in their appearance.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 80 years
- Gender
- Both males and females
Description
This is a phase III multi-center, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease experiencing...
This is a phase III multi-center, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease experiencing motor fluctuations. This study is comprised of 6 periods: a Screening Period; an open-label oral IR-LD/CD Adjustment Period. an open-label ND0612 Conversion Period. a randomized, double-blind, double-dummy, active-controlled Maintenance Period. an optional open-label Treatment Extension; and a Safety Follow-up Period.
Tracking Information
- NCT #
- NCT04006210
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Alberto J Espay, MD, MSc University of Cincinnati OH, USA Principal Investigator: Olivier Rascol, MD, PhD Toulouse University Hospital, France
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