NeuroDerm starts phase III trial of NDO612L in Parkinson’s disease

ND0612L is a low-dose continuous subcutaneously administered levodopa/carbidopa liquid formulation.  Parkinson’s disease is a progressive neurodegenerative illness characterized by reduced dopamine levels in the brain.

The multicenter, double-blind, placebo-controlled international study, iNDiGO, will randomize 150 subjects to receive either a continuous infusion of ND0612L or placebo replaced every 24 hours for 16 weeks.

The trial is designed to compare ND0612L therapy to oral standard-of-care apart from placebo.

The primary endpoint is the change from baseline to week 16 in the mean percentage of OFF time during waking hours as measured by patients’ home diary assessments.

NeuroDerm reduced the number of patients targeted for enrollment to 150 from 200-240 depending on observed and expected treatment effect.

In the earlier phase II trial, adjunct ND0612L therapy was demonstrated to maintain high trough LD plasma levels and to reduce OFF time by two hours compared to the control arm, oral standard-of-care with placebo.

The iNDiGO trial is expected to complete in 2017. ND0612L is further being developed for future delivery via a small patch pump that is expected to provide a new level of therapy convenience.

NeuroDerm CEO Oded Lieberman said: “The initiation of the iNDiGO trial marks another important milestone in the development of ND0612L as part of our Parkinson’s disease treatment pipeline.

“We believe that ND0612L holds tremendous potential in providing PD patients with a simple, continuous levodopa delivery treatment option that does not require surgery.”

Image: Parkinson’s disease is a progressive neurodegenerative illness characterized by reduced dopamine levels in the brain. Photo: courtesy of dream designs at FreeDigitalPhotos.net.