ND0612-317: 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)

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. 1. a Screening Period;

  2. 2. an open-label oral IR-LD/CD Adjustment Period.

  3. 3. an open-label ND0612 Conversion Period.

  4. 4. a randomized, double-blind, double-dummy, active-controlled Maintenance Period.

  5. 5. an optional open-label Treatment Extension; and

  6. 6. a Safety Follow-up Period.

Inclusion Criteria:

  1. 1. Male and female patients, aged ≥30 years.

  2. 2. PD diagnosis consistent with the UK Brain Bank Criteria.

  3. 3. Modified Hoehn & Yahr score ≤3 during ON.

  4. 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. 5. Taking ≥4 levodopa doses/day (≥3 doses/day of Rytary) at a total daily dose of ≥400mg.

Exclusion Criteria:

  1. 1.Atypical or secondary parkinsonism.

  2. 2. Severe disabling dyskinesias.

  3. 3. Previous neurosurgery for PD.

  4. 4. Use of duodenal levodopa infusion (LCIG)* or apomorphine infusion.

  5. 5. Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.

  6. 6. Previous participation in ND0612 studies.

  7. 7. History of significant skin conditions or disorders.