This study is in progress, not accepting new patients

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

a study on Parkinson's Disease

Summary

Eligibility
for people ages 30 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

A Multicenter, 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 (BouNDless)

Details

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.

Keywords

Parkinson's Disease, Parkinson Disease, ND0612 Solution for SC infusion, Oral IR-LD/CD, Oral IR-LD/CD Adjustment, ND0612 Conversion, Open-Label Extension

Eligibility

You can join if…

Open to people ages 30 years and up

  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.

You CAN'T join if...

  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.

Locations

  • UCSF
    San Francisco California 94115 United States
  • SC3 Research - Reseda
    Reseda California 91335 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NeuroDerm Ltd.
ID
NCT04006210
Phase
Phase 3 Parkinson's Disease Research Study
Study Type
Interventional
Participants
About 381 people participating
Last Updated