A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO)

INTERVENTION: Product Name: levodopa/carbidopa solution Product Code: ND0612 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Levodopa CAS Number: 59‐92‐7 Other descriptive name: Levodopa Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60‐ INN or Proposed INN: Carbidopa CAS Number: 38821‐49‐7 Other descriptive name: CARBIDOPA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 7.5‐ Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Subcutaneous use CONDITION: Subjects with Parkinson’s Disease with motor fluctuations ; MedDRA version: 19.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To determine the effect of ND0612 on daily “OFF” time using a subject completed home diary. Primary end point(s): The primary endpoint is the change from Baseline to Week 16 in the mean percentage of “OFF” time; during waking hours, based on patient's home diary assessments on 3 consecutive days before the visit.; The “OFF” time will also be presented as hours normalized to 16 waking hours. Secondary Objective: To determine the effect of ND0612 on daily “ON” time without troublesome dyskinesia (defined as the sum of "ON" time without dyskinesia and “ON” time with non‐troublesome dyskinesia) using a subject completed home diary. Timepoint(s) of evaluation of this end point: Week 16 visit SECONDARY OUTCOME: Secondary end point(s): The key secondary efficacy endpoint is the change from Baseline to Week 16 in the mean percentage of “ON” time without troublesome dyskinesia during waking hours, based on patient's home diary assessments on the 3 consecutive days before the visit. "ON" time without troublesome dyskinesia is defined as the sum of "ON" time without dyskinesia and “ON” time with non‐troublesome dyskinesia. Timepoint(s) of evaluation of this end point: Week 16 visit INCLUSION CRITERIA: 1. Male and female PD subjects of any race aged 30‐80 years 2. PD diagnosis consistent with the UK Brain Bank Criteria. 3. Modified Hoehn & Yahr scale in “ON” state =3 4. Subjects must experience motor fluctuations and experience an average of at least 2 hours daily in the “OFF” state 5. Taking at least 4 doses/day of IR LD/DDI (or at least 3 doses/day of Rytary) and taking, or having taken therapeutic doses of at least 2 other classes of anti‐PD medications. 6. Subjects must be on stable doses of all their anti‐PD medications for at least 28 days before Baseline (Day 1). 7. Subject and/or study partner must demonstrate ability to keep accurate diary entries of PD symptoms (“ON‐OFF” diaries) with at least 75% concordance with the study rater by the end of the diary training session at the end of the screening period. 8. Mini Mental State Examination (MMSE) score >26. 9. Female subjects must be surgically sterile (hysterectomy, bilateral