Date: 2011-11-09
Type of information:
phase: 1-2
Announcement: results
Company: NeuroDerm (Israel)
Product: ND0611 Dermal Patch
Action mechanism: ND0611 is based on a proprietary formulation that enables the continuous administration of carbidopa in a practical manner via a subcutaneous dermal patch. Carbidopa, conventionally co-administered with levodopa orally to prevent its breakdown, suffers from low bioavailability in itself. Continuous subcutaneous delivery of carbidopa should thus improve the bioavailability of oral levodopa, permit more continuous levels of levodopa to be maintained in the brain, improve the management of motor fluctuations in Parkinson\'s disease patients and result in a more efficacious usage of levodopa in Parkinson\'s disease therapy.
Disease: Parkinson's disease
Therapeutic area: Neurodegenerative diseases - CNS diseases
Country:
Trial details: This placebo controlled, randomized, double-blind, six-way crossover trial enrolled 24 patients with advanced Parkinson's disease. All patients were administered the three most commonly-used levodopa therapies (immediate-release Sinemet®, Sinemet®-CR, and Stalevo®) in 100mg dosage four times per day; in addition they received either ND0611 or placebo.
Latest
news: NeuroDerm has announced the results of a Phase I/II safety and pharmacokinetic trial of ND0611, administered as an adjunct therapy to Sinemet®, Sinemet® CR or Stalevo®, in patients with advanced Parkinson's disease. Results of this study support the continued development of ND0611 for the treatment of Parkinson's disease.
This double-blind, randomized, six-way crossover study met all of its primary and secondary endpoints. The analysis showed that ND0611, when compared with placebo, showed meaningful, highly statistically significant improvement in all of the pharmacokinetic (PK) endpoints when administered with three most common oral levodopa therapies (immediate-release Sinemet®, Sinemet®-CR, and Stalevo®).
The primary and secondary PK endpoints included levodopa half-life, the duration of levodopa concentration in excess of a threshold of 1000ng/ml in plasma, the area-under-the-concentration-time-curve and levodopa trough levels. The full results of this study will be presented at a future scientific meeting.
The most common adverse events across all treatment arms, including placebo, were vertigo, nausea, asthenia, back pain, myalgia, pain in extremity, headache and erythema. There were no clinically relevant effects seen in laboratory measured or vital signs.
In addition to evaluating safety and tolerability, the study\'s primary endpoint was improvement in levodopa half life in all treatment arms; secondary endpoints included additional PK parameters. All PK parameters for each oral treatment mode were evaluated separately and showed statistical significance.
This trial was supported by a grant of $1 million by The Michael J. Fox Foundation for Parkinson's Research as part of the Foundation's Clinical Intervention Awards 2010 program.
