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)
Sponsor:
Brief Summary:
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
LD/CD.
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
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.
Locations
- 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
