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:
1. a Screening Period;
2. an open-label oral IR-LD/CD Adjustment Period.
3. an open-label ND0612 Conversion Period.
4. a randomized, double-blind, double-dummy, active-controlled Maintenance Period.
5. an optional open-label Treatment Extension; and
6. a Safety Follow-up Period.
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.