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).
Age: 30 - 80 years
Healthy Subjects: No
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: August 27, 2019
End Date: April 28, 2021
1. Male and female patients, aged ≥30 years.
2. PD diagnosis consistent with the UK Brain Bank Criteria.
3. Modiﬁed Hoehn & Yahr score ≤3 during ON.
4. Average of ≥2.5 hours of OFF time (≥2 hours OFF every day) during waking hours as conﬁrmed by patient diary over 3 days.
5. Taking ≥4 levodopa doses/day (≥3 doses/day of extended release LD/DDI, e.g.,Rytary®) at a total daily dose of ≥400mg.
1. Atypical or secondary parkinsonism.
2. Severe disabling dyskinesias, based on Investigator's discretion.
3. Previous neurosurgery for PD.
4. Use of duodenal levodopa infusion (LCIG)* or apomorphine infusion.
5. Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
6. Previous participation in ND0612 studies.
7. History of signiﬁcant skin conditions or disorders.
- Parkinson Disease