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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)

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ClinicalTrials.gov Identifier: NCT04006210
Recruitment Status : Active, not recruiting
First Posted : July 5, 2019
Last Update Posted : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Combination Product: ND0612 Solution for SC infusion Combination Product: Placebo for SC infusion Drug: Oral IR-LD/CD Drug: Placebo for Oral IR-LD/CD Phase 3

Detailed 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:

  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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Oral IR-LD/CD Adjustment Period - Run-in 1 (1 arm) followed by ND0612 Conversion Period - Run-in 2 (1 arm) followed by DBDD Parallel Group Maintenance Period (2 arms) followed by optional Open-label Extension Period (1 arm)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinded Site Rater, Blinded Clinical Research Associates (CRAs), active drugs and matching placebos are identical in their appearances.
Primary Purpose: Treatment
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)
Actual Study Start Date : September 30, 2019
Actual Primary Completion Date : November 1, 2022
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ND0612 Group
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
 Combination Product: ND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump

Drug: Oral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
Other Name: IR-LD/CD

Drug: Placebo for Oral IR-LD/CD
Encapsulated Placebo for LD/CD 100mg/25mg
Other Name: Placebo for IR-LD/CD
Active Comparator: IR-LD/CD Group
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.
 Combination Product: Placebo for SC infusion
Placebo solution administered SC via infusion pump

Drug: Oral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
Other Name: IR-LD/CD

Drug: Placebo for Oral IR-LD/CD
Encapsulated Placebo for LD/CD 100mg/25mg
Other Name: Placebo for IR-LD/CD
Oral IR-LD/CD Adjustment
Active IR-LD/CD (white capsules). Open-label Treatment in Run-in 1 for 4-6 weeks.
 Drug: Oral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
Other Name: IR-LD/CD
ND0612 Conversion
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks.
 Combination Product: ND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump

Drug: Oral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
Other Name: IR-LD/CD
Open-Label Extension
ND0612 continuous SC infusion + Standard of care LD/dopa-decarboxylase inhibitor. Open-label Treatment in Extension for up to 54 months.
 Combination Product: ND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump


Outcome Measures
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Primary Outcome Measures :
  1. The change in daily ON time without troublesome dyskinesia [ Time Frame: Baseline to the end of DBDD Maintenance Period (12 weeks) ]
    ON time without troublesome dyskinesia is the sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia per patient diary


Secondary Outcome Measures :
  1. The change in daily OFF time [ Time Frame: Baseline to the end of DBDD Maintenance Period (12 weeks) ]
    OFF time per patient diary


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006210


Locations
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Sponsors and Collaborators
NeuroDerm Ltd.
Investigators
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Principal Investigator: Alberto J Espay, MD, MSc University of Cincinnati OH, USA
Principal Investigator: Olivier Rascol, MD, PhD Toulouse University Hospital, France
More Information
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Additional Information:

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Responsible Party: NeuroDerm Ltd.
ClinicalTrials.gov Identifier: NCT04006210    
Other Study ID Numbers: ND0612-317
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: November 7, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases