NeuroDerm has started enrolling Parkinson’s disease (PD) patients in iNDiGO, a Phase 3 clinical trial evaluating the effectiveness of ND0612L, the company’s levodopa/carbidopa (LD/CD) subcutaneous liquid formulation.
Levodopa and dopamine agonists, the first line of defense against Parkinson’s disease, are drugs commonly used to improve and control the symptoms of tremor, muscular rigidity, and slow, imprecise movement.
Over time, however, Parkinson’s patients start to develop motor fluctuations, the result of variations in patients’ response to levodopa. Motor fluctuations oscillate between “off” times, a state of decreased mobility, and “on” times, or periods when the medication is working and symptoms are controlled.
ND0612L is being developed to treat moderate stage Parkinson’s patients who can no longer effectively control their motor complications with oral levodopa. ND0612L can be continuously administered as a fixed dose over 24 hours. ND0612L maintains steady plasma levodopa concentrations, which should improve Parkinson’s patients’ motor and non-motor complications, including dyskinesia and “off” periods.
iNDiGO (NCT02782481) is a 16-week multicenter, randomized, double-blind, placebo-controlled clinical trial that will compare the effectiveness, safety and tolerability of ND0612L combined with oral standard of care or a placebo in Parkinson’s patients who have motor fluctuations despite optimized standard-of-care therapy.
Patients will be randomly assigned either to ND0612L or a placebo that will be replaced every 24 hours. The primary endpoint of iNDiGO is the change from baseline to week 16 in the mean percentage of “OFF” time based on patients’ home diary assessments.
The original trial design anticipated enrolling 200-240 patients, but NeuroDerm reduced this number to 150 patients after sample size calculations using the expected treatment effect and variability as well as those observed in a previous Phase 2 clinical trial.
In that Phase 2 trial, patients with moderate to severe Parkinson’s disease who received adjunct ND0612L therapy exhibited clinically significant reduction in fluctuations of plasma levodopa concentrations compared to patients receiving a placebo. Patients receiving ND0612L also experienced a corresponding in-clinic two-hour reduction over placebo in “off” time, improved sleep, better quality of life and global clinical improvement without an increase in troublesome dyskinesia.
The iNDiGO trial is expected to end in 2017.
“The initiation of the iNDiGO trial marks another important milestone in the development of ND0612L as part of our Parkinson’s disease treatment pipeline,” NeuroDerm CEO Oded S. Lieberman, PhD, said in a press release. “The current reduction in the number of patients to be enrolled in our iNDiGO trial, following streamlining this past November of our clinical development program from two Phase 3 trials to one trial, should further simplify and facilitate our clinical development program for ND0612L.”
“We believe that ND0612L holds tremendous potential in providing PD patients with a simple, continuous levodopa delivery treatment option that does not require surgery. ND0612L is further being developed for future delivery through a small patch pump that should offer a new level of therapy convenience. We are committed to making this promising candidate available to patients as quickly as possible and are pleased to have this trial underway,” Lieberman said.