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Trial record 8 of 11 for:    nd0612

A 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).

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ClinicalTrials.gov Identifier: NCT04006210
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.

Tracking Information
First Submitted Date  ICMJE June 30, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE August 27, 2019
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2019)
The change from Baseline to the end of the double-blind assessment period in daily ON time without troublesome dyskinesia (sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia) per patient diary. [ Time Frame: Baseline to DBDD Maintenance Period (12 weeks) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2019)
The change from Baseline to the end of the double-blind assessment period in OFF time per patient diary. [ Time Frame: Baseline to DBDD Maintenance Period (12 weeks) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 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).
Official Title  ICMJE 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)
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

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Combination Product: ND0612 Solution for SC infusion
    Levodopa Carbidopa solution administered SC via infusion pump
  • 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
Study Arms  ICMJE
  • Experimental: Group A
    ND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.
    Interventions:
    • Combination Product: ND0612 Solution for SC infusion
    • Drug: Carbidopa and Levodopa 25mg/100mg
    • Drug: Placebo for Carbidopa and Levodopa 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.
    Interventions:
    • Combination Product: Placebo for SC infusion
    • Drug: Carbidopa and Levodopa 25mg/100mg
    • Drug: Placebo for Carbidopa and Levodopa 25mg/100mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2020)
380
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2019)
300
Estimated Study Completion Date  ICMJE October 30, 2023
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eran Tavor 927-545640943 erant@neuroderm.com
Contact: Hila Eitan 972-54-5500769 hila@neuroderm.com
Listed Location Countries  ICMJE Austria,   Belgium,   Czechia,   France,   Hungary,   Israel,   Italy,   Netherlands,   Poland,   Portugal,   Russian Federation,   Serbia,   Slovakia,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04006210
Other Study ID Numbers  ICMJE ND0612-317
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NeuroDerm Ltd.
Study Sponsor  ICMJE NeuroDerm Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alberto J Espay, MD, MSc University of Cincinnati OH, USA
Principal Investigator: Olivier Rascol, MD, PhD Toulouse University Hospital, France
PRS Account NeuroDerm Ltd.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP