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Purpose

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

Condition

Eligibility

Eligible Ages
Between 30 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Rytary) at a total daily dose of ≥400mg.

Exclusion Criteria

  1. Atypical or secondary parkinsonism.
  2. Severe disabling dyskinesias.
  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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Blinded Site Rater, Blinded CRAs, active drugs and matching placebo are identical in their appearance.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A
ND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.
  • Combination Product: ND0612 Solution for SC infusion
    Levodopa Carbidopa solution administered SC via infusion pump
  • Drug: Carbidopa and Levodopa 25mg/100mg
    Encapsulated Carbidopa and Levodopa USP 25mg/100mg
  • Drug: Placebo for Carbidopa and Levodopa 25mg/100mg
    Encapsulated Placebo for Carbidopa and Levodopa USP 25mg/100mg
Active Comparator
Group B
Placebo for ND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.
  • Combination Product: Placebo for SC infusion
    Placebo solution administered SC via infusion pump
  • Drug: Carbidopa and Levodopa 25mg/100mg
    Encapsulated Carbidopa and Levodopa USP 25mg/100mg
  • Drug: Placebo for Carbidopa and Levodopa 25mg/100mg
    Encapsulated Placebo for Carbidopa and Levodopa USP 25mg/100mg

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky, Neurology and Movement Disorder
Lexington, Kentucky 40536-0284
Contact:
Renee Wagner
renee.wagner@uky.edu

More Details

NCT ID
NCT04006210
Status
Recruiting
Sponsor
NeuroDerm Ltd.

Study Contact

Yael Ullmann, BPharm
972-547610102
Ullmann.y@neuroderm.com

Detailed Description

This is a phase III multi-center, randomized, active-controlled, double-blind, double-dummy, parallel group 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.

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, double-blind, double-dummy, active-controlled Maintenance Period.

5. an optional open-label Treatment Extension; and

6. a Safety Follow-up Period.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.