This study is in progress, not accepting new patients

Efficacy, Safety and Tolerability Study of ND0612 vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations

a study on Parkinson's Disease

Summary

Eligibility
for people ages 30-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Study of the Efficacy, Safety, and Tolerability of Continuous SC ND0612 Infusion vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations

Details

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.

Keywords

Parkinson's Disease, Parkinson Disease, Levodopa, Carbidopa, ND0612 Solution for SC infusion, Carbidopa and Levodopa 25mg/100mg

Eligibility

You can join if…

Open to people ages 30-80

  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 extended release LD/DDI, 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

  • University of California San Francisco
    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