Parkinson's Disease
Conditions
Brief summary
This is a multi-center, randomized, double-blind, double-dummy, 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.
Detailed description
This is a phase III multi-center, randomized, active-controlled, double-blind, double-dummy (DBDD), parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous (SC) ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease (PD) 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 DBDD active-controlled Maintenance Period; 5. an optional open-label Treatment Extension; and 6. a Safety Follow-up Period.
Interventions
COMBINATION_PRODUCTND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump
COMBINATION_PRODUCTPlacebo for SC infusion
Placebo solution administered SC via infusion pump
DRUGOral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
DRUGPlacebo for Oral IR-LD/CD
Encapsulated Placebo for LD/CD 100mg/25mg
Sponsors
NeuroDerm Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Blinded Site Rater, Blinded Clinical Research Associates (CRAs), active drugs and matching placebos are identical in their appearances.
Intervention model description
Oral IR-LD/CD Adjustment Period - Run-in 1 (1 arm) followed by ND0612 Conversion Period - Run-in 2 (1 arm) followed by DBDD Parallel Group Maintenance Period (2 arms) followed by optional Open-label Extension Period (1 arm)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female patients, aged ≥30 years. 2. PD diagnosis consistent with the United Kingdom Brain Bank Criteria. 3. Modified Hoehn & Yahr score ≤3 during ON state. 4. Average of ≥2.5 hours of OFF time (≥2 hours OFF time 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/dopa-decarboxylase inhibitor, 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in daily ON time without troublesome dyskinesia | Baseline to the end of DBDD Maintenance Period (12 weeks) | ON time without troublesome dyskinesia is the sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia per patient diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in daily OFF time | Baseline to the end of DBDD Maintenance Period (12 weeks) | OFF time per patient diary |
Countries
Austria, Belgium, Czechia, France, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Russia, Slovakia, Spain, Ukraine, United Kingdom, United States
Outcome results
None listed