skip to Main Content

A Multicenter, 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 (BouNDless)


Brief Summary:

This is a multi-center, randomized, double blind, active controlled clinical Study. Following
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:


Inclusion Criteria:

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.

Exclusion Criteria:

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
Back To Top