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

You CAN'T join if...

  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.

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94115 United States
  • SC3 Research - Reseda accepting new patients
    Reseda California 91335 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NeuroDerm Ltd.
Links
To contact US site near you should go to:
ID
NCT04006210
Phase
Phase 3
Study Type
Interventional
Last Updated