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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04006210
Recruitment Status : Active, not recruiting
First Posted : July 5, 2019
Last Update Posted : May 25, 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, 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


Condition or disease Intervention/treatment Phase
Parkinson's Disease Combination Product: ND0612 Solution for SC infusion Combination Product: Placebo for SC infusion Drug: Carbidopa and Levodopa 25mg/100mg Drug: Placebo for Carbidopa and Levodopa 25mg/100mg Phase 3

Detailed Description:

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinded Site Rater, Blinded CRAs, active drugs and matching placebo are identical in their appearance.
Primary Purpose: Treatment
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
Actual Study Start Date : September 30, 2019
Actual Primary Completion Date : November 1, 2022
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
ND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.
 Combination Product: ND0612 Solution for SC infusion
Levodopa Carbidopa solution administered SC via infusion pump

Drug: Carbidopa and Levodopa 25mg/100mg
Encapsulated Carbidopa and Levodopa USP 25mg/100mg

Drug: Placebo for Carbidopa and Levodopa 25mg/100mg
Encapsulated Placebo for Carbidopa and Levodopa USP 25mg/100mg
Active Comparator: Group B
Placebo for ND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.
 Combination Product: Placebo for SC infusion
Placebo solution administered SC via infusion pump

Drug: Carbidopa and Levodopa 25mg/100mg
Encapsulated Carbidopa and Levodopa USP 25mg/100mg

Drug: Placebo for Carbidopa and Levodopa 25mg/100mg
Encapsulated Placebo for Carbidopa and Levodopa USP 25mg/100mg


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 to 80 Years   (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 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.

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: May 25, 2023
Last Verified: May 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
Levodopa
 Carbidopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors