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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

Phase 3
Active, not recruiting
Conditions
Parkinson's Disease
Interventions
Combination Product: Placebo for SC infusion
Drug: Oral IR-LD/CD
Combination Product: ND0612 Solution for SC infusion
Drug: 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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
IR-LD/CD GroupPlacebo for SC infusionPlacebo 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 AdjustmentOral IR-LD/CDActive IR-LD/CD (white capsules). Open-label Treatment in Run-in 1 for 4-6 weeks.
ND0612 GroupOral IR-LD/CDND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
ND0612 GroupPlacebo for Oral IR-LD/CDND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
ND0612 ConversionND0612 Solution for SC infusionND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks.
IR-LD/CD GroupPlacebo for Oral IR-LD/CDPlacebo 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 GroupOral IR-LD/CDPlacebo 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 GroupND0612 Solution for SC infusionND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
ND0612 ConversionOral IR-LD/CDND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks.
Open-Label ExtensionND0612 Solution for SC infusionND0612 continuous SC infusion + Standard of care LD/dopa-decarboxylase inhibitor. Open-label Treatment in Extension for up to 54 months.
Primary Outcome Measures
NameTimeMethod
The change in daily ON time without troublesome dyskinesiaBaseline 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
NameTimeMethod
The change in daily OFF timeBaseline 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

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Xenoscience
🇺🇸Phoenix, Arizona, United States

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