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出境医 / 临床实验 / 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).

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).

Study Description
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)
Estimated Enrollment : 380 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 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 : August 27, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : October 30, 2023
Arms and Interventions
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
Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]

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

Contacts
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Contact: Eran Tavor 927-545640943 erant@neuroderm.com
Contact: Hila Eitan 972-54-5500769 hila@neuroderm.com

Locations
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