Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
- Conditions
- Parkinson's Disease
- Interventions
- Combination Product: Placebo for SC infusionDrug: Oral IR-LD/CDCombination Product: ND0612 Solution for SC infusionDrug: Placebo for Oral IR-LD/CD
- Registration Number
- NCT04006210
- Lead Sponsor
- NeuroDerm Ltd.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 381
- Male and female patients, aged ≥30 years.
- PD diagnosis consistent with the United Kingdom Brain Bank Criteria.
- Modified Hoehn & Yahr score ≤3 during "ON" state.
- 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.
- 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.
- Atypical or secondary parkinsonism.
- Severe disabling dyskinesias, based on Investigator's discretion.
- Previous neurosurgery for PD.
- Use of duodenal levodopa infusion (LCIG) or apomorphine infusion.
- Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
- Previous participation in ND0612 studies.
- History of significant skin conditions or disorders.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IR-LD/CD Group Placebo for SC infusion Placebo for ND0612 continuous SC infusion + Placebo IR-LD/CD (grey capsules) + Active IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks. Oral IR-LD/CD Adjustment Oral IR-LD/CD Active IR-LD/CD (white capsules). Open-label Treatment in Run-in 1 for 4-6 weeks. ND0612 Group Oral IR-LD/CD ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks. ND0612 Group Placebo for Oral IR-LD/CD ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks. ND0612 Conversion ND0612 Solution for SC infusion ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks. IR-LD/CD Group Placebo for Oral IR-LD/CD Placebo for ND0612 continuous SC infusion + Placebo IR-LD/CD (grey capsules) + Active IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks. IR-LD/CD Group Oral IR-LD/CD Placebo for ND0612 continuous SC infusion + Placebo IR-LD/CD (grey capsules) + Active IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks. ND0612 Group ND0612 Solution for SC infusion ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks. ND0612 Conversion Oral IR-LD/CD ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks. Open-Label Extension ND0612 Solution for SC infusion ND0612 continuous SC infusion + Standard of care LD/dopa-decarboxylase inhibitor. Open-label Treatment in Extension for up to 54 months.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The change in daily OFF time Baseline to the end of DBDD Maintenance Period (12 weeks) OFF time per patient diary
Trial Locations
- Locations (103)
Xenoscience
🇺🇸Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Cedar- Sinai Medical Center Department of Neurology
🇺🇸Los Angeles, California, United States
SC3 Research - Reseda
🇺🇸Reseda, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Rocky Mountain Movement Disorders Center
🇺🇸Englewood, Colorado, United States
Hartford Healthcare Chase Family Movement Disorders Center
🇺🇸Vernon, Connecticut, United States
Visionary Investigators Network
🇺🇸Aventura, Florida, United States
Parkinsons Disease and Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
University of Florida Norman Fixel Institute for Neurological Diseases
🇺🇸Gainesville, Florida, United States
Scroll for more (93 remaining)Xenoscience🇺🇸Phoenix, Arizona, United States