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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 November 2023 |
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Main ID: |
NCT04006210 |
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Date of registration:
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30/06/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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) |
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Date of first enrolment:
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September 30, 2019 |
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Target sample size:
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381 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04006210 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Belgium
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Czechia
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France
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Hungary
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Israel
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Italy
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Netherlands
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Poland
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Portugal
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Russian Federation
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Serbia
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Slovakia
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Spain
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Alberto J Espay, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Cincinnati OH, USA |
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Name:
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Olivier Rascol, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Toulouse University Hospital, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male and female patients, aged =30 years.
2. PD diagnosis consistent with the United Kingdom Brain Bank Criteria.
3. Modi?ed 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 con?rmed 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 signi?cant skin conditions or disorders.
Age minimum:
30 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Oral IR-LD/CD
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Drug: Placebo for Oral IR-LD/CD
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Combination Product: ND0612 Solution for SC infusion
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Combination Product: Placebo for SC infusion
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Primary Outcome(s)
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The change in daily ON time without troublesome dyskinesia
[Time Frame: Baseline to the end of DBDD Maintenance Period (12 weeks)]
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Secondary Outcome(s)
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The change in daily OFF time
[Time Frame: Baseline to the end of DBDD Maintenance Period (12 weeks)]
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Secondary ID(s)
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ND0612-317
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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