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).

ID#: NCT04006210

Age: 30 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: August 27, 2019

End Date: April 28, 2021

Contact Information:
Eran Tavor
Hila Eitan
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 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

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 extended release LD/DDI, e.g.,Rytary®) at a total daily dose of ≥400mg.

Exclusion Criteria:

1. Atypical or secondary parkinsonism.

2. Severe disabling dyskinesias, based on Investigator's discretion.

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.