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The trial is taking place at:
M

Michigan State University | Department of Neurology

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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 (BouNDless)

N

NeuroDerm

Status and phase

Active, not recruiting
Phase 3

Conditions

Parkinson's Disease

Treatments

Combination Product: ND0612 Solution for SC infusion
Drug: Placebo for Oral IR-LD/CD
Drug: Oral IR-LD/CD
Combination Product: Placebo for SC infusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT04006210
ND0612-317

Details and patient eligibility

About

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.

Full 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:

a Screening Period; an open-label oral IR-LD/CD Adjustment Period; an open-label ND0612 Conversion Period; a randomized DBDD active-controlled Maintenance Period; an optional open-label Treatment Extension; and a Safety Follow-up Period.

Enrollment

381 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

381 participants in 5 patient groups

ND0612 Group
Experimental group
Description:
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
Treatment:
Drug: Oral IR-LD/CD
Drug: Placebo for Oral IR-LD/CD
Combination Product: ND0612 Solution for SC infusion
IR-LD/CD Group
Active Comparator group
Description:
Placebo for ND0612 continuous SC infusion + Placebo IR-LD/CD (grey capsules) + Active IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
Treatment:
Combination Product: Placebo for SC infusion
Drug: Oral IR-LD/CD
Drug: Placebo for Oral IR-LD/CD
Oral IR-LD/CD Adjustment
Other group
Description:
Active IR-LD/CD (white capsules). Open-label Treatment in Run-in 1 for 4-6 weeks.
Treatment:
Drug: Oral IR-LD/CD
ND0612 Conversion
Other group
Description:
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks.
Treatment:
Drug: Oral IR-LD/CD
Combination Product: ND0612 Solution for SC infusion
Open-Label Extension
Other group
Description:
ND0612 continuous SC infusion + Standard of care LD/dopa-decarboxylase inhibitor. Open-label Treatment in Extension for up to 54 months.
Treatment:
Combination Product: ND0612 Solution for SC infusion

Trial contacts and locations

103

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Data sourced from clinicaltrials.gov

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