Date: 2011-03-09
Type of information:
phase: 2
Announcement: enrollment of the first patients
Company: NeuroDerm (Israel)
Product: ND0611 Dermal Patch
Action mechanism: ND0611, a proprietary carbidopa liquid formula administered via a dermal patch, is designed to increase the bioavailability and efficacy of orally- administered levodopa and thus improve treatment of Parkinson’s disease. In pre-clinical studies, plasma concentrations of orally-administered levodopa showed markedly less fluctuation, higher area-under-the-curve values, and higher trough concentrations after continuous administration of ND0611 together with standard levodopa products (Sinemet®, Stalevo® and Sinemet® CR).
Disease: Parkinson’s disease
Therapeutic area: Neurodegenerative diseases - CNS diseases
Country:
Trial details: This double-blind, randomized, six-way crossover Phase I/II trial is designed to evaluate ND0611’s safety, tolerability, levodopa bioavailability, and preliminary clinical efficacy when administered with the three most commonly-used levodopa therapies (immediate-release Sinemet®, Sinemet®-CR, and Stalevo®) in 24 advanced Parkinson’s disease patients.
Latest
news: NeuroDerm has announced the enrollment of the first group of patients in its Phase I/II clinical trial of ND0611, a new patch for the treatment of Parkinson’s disease. A phase I trial in young, healthy volunteers demonstrated that ND0611, co-administered with Sinemet®, was safe and tolerable. It also showed that ND0611 increased levodopa clearance half-life, the duration of levodopa concentration in excess of a typical threshold for anti-Parkinsonian effect (1000ng/ml in plasma), and the area-under-the-concentration-time-curve of levodopa.
This double-blind, randomized, six-way crossover Phase I/II trial is supported by a grant of $1M by The Michael J. Fox Foundation for Parkinson’s Research as part of the Foundation’s prestigious Clinical Intervention Awards 2010 program. The company expects to complete this study by the end of 2011.
