BouNDless
Research type
Research Study
Full 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)
IRAS ID
272434
Contact name
Talia Schloss
Contact email
Sponsor organisation
NeuroDerm Ltd.
Eudract number
2018-004156-37
Duration of Study in the UK
2 years, 4 months, 14 days
Research summary
Oral tablets that combine levodopa and carbidopa (LD/CD) have been used for more than 40 years to treat the symptoms of Parkinson's Disease (PD). In the early stages of LD treatment PD patients experience benefits that are sustained, even if an individual's dose is missed. However, with chronic treatment, the duration of benefit after a given dose of LD becomes progressively shorter. Patients begin to experience fluctuations in motor function alternating between “ON” state, when the treatment is providing benefit and “OFF”state, when the treatment has worn off.
ND0612, a solution of LD/CD that is administered continuously under the skin via an infusion pump ensures the constant delivery of LD to the plasma. This may lead to a reduction in the motor fluctuations compared to what can be achieved by oral LD/CD tablets. In this study, we will compare how well ND0612 works compared to oral tablets of LD/CD and how safe the study drug is. Since this is a controlled clinical trial, patients who are randomised to the control group will not receive the active ND0612 solution, rather they will receive the inactive (placebo) treatment.
This study will take place in approximately 120 hospitals across 20 countries around the world in approximately 350 PD patients. To be eligible participants must be over the age of 30 and meet the study specific requirements, this includes being capable of performing the required procedures alone or with the help of a study partner.
Participants will be expected to be on this study for approximately 40 weeks and for an additional year if they take part in the optional treatment extension period (total of 92 weeks).
REC name
London - Central Research Ethics Committee
REC reference
19/LO/1892
Date of REC Opinion
14 Jan 2020
REC opinion
Further Information Favourable Opinion