The BouNDless study is a multi-center (4 locations), randomized, active-controlled, double-blind, double-dummy, parallel-group design. After screening, subjects will start on an open label immediate release (IR) LD/CD adjustment period, followed by a ND0612 open-label adjustment period. Once optimised, patients will be randomised to receive either ND0612 or matching placebo, both accompanied by IR LD/CD. There is an option to move to an open-label extension study (NCT02726386) lasting for a further year.
Neuroderm plans to recruit patients with moderate to advanced PD, between the ages of 30 and 80. They must have a good response to levodopa, with a modified Hoehn & Yahr score of ≤3 when ON. There must be at least 2 hours of OFF time per day. The patient must be taking ≥4 levodopa doses/day (≥3 doses/day of Rytary) at a total daily dose of ≥400mg.
The primary outcome measure is the change in daily ON time without troublesome dyskinesia (sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia) using a patient diary over 12 weeks.
The secondary outcome measure is the change in OFF time using a patient diary, also over 12 weeks.
Together with Abbvie’s ABBV-951, ND0612 will offer an alternative to intra-jejunal gels, potentially with more control of dosage to obtain optimal symptom relief. This mode of delivery of LD/CD is likely to be much more acceptable to patients, hopefully at a lower overall cost. The disadvantage of ND0612 is a limit of levodopa dose that can be delivered via the pump over 24 hours which will require use of add on oral medications by most patients.