a screening period, eligible subjects will be enrolled to an open-label oral IR LD/CD
adjustment period; then an open-label ND0612 conversion period; then after optimization
periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR
Subjects can continue to an optional open-label extension period for one year; To contact US
site near you should go to: www.BouNDless-Study.com
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 Rytary) at a total daily dose of ≥400mg.
1. Atypical or secondary parkinsonism.
2. Severe disabling dyskinesias.
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.
- The Research Center of Southern California, Carlsbad, California, United States, 92011
- Collaborative Neuroscience Network, Long Beach, California, United States, 90806
- SC3 Research – Reseda, Reseda, California, United States, 91335
- University of California San Francisco, San Francisco, California, United States, 94115