Phase 1/2 study of NP002 for the treatment of levodopa-induced dyskinesias (LIDs)
Neuraltus announced results from its Phase 1/2 study of NP002 for the treatment of dyskinesias (muscle movement disorders) resulting from levodopa therapy for patients with Parkinson's disease (PD). The primary objective of the double-blind, placebo controlled study was the establishment of safety and tolerability of NP002, with patients being assessed over a 14-week treatment and monitoring period. The secondary objective was to investigate the effects of NP002 on a set of Parkinson's disease and dyskinesia assessment scales, including The Unified Parkinson's Disease Rating Scale (UPDRS), the Unified Dyskinesia Rating Scale (UDRS), the Lang-Fahn Activities of Daily Living Scale (LF-ADL), and the clinician and patient global impressions of change scales (CGIC and PGIC).
NP002 administered concurrently with levodopa was found to be generally safe and well-tolerated in Parkinson's patients with LIDs. NP002 was not associated with any impulsivity or withdrawal issues when compared to placebo. Although the trial was not powered as an efficacy study, clinically relevant trends and, in two cases, statistical superiority of NP002 over placebo were observed in a variety of physician- and patient-rated PD efficacy outcome measures relating to dyskinesias.
NP002 is a small molecule, orally available nicotinic receptor agonist that has been shown in preclinical studies to reduce LIDs without affecting Parkinsonian symptoms.
For more information call (650) 424-1600 or visit www.neuraltus.com.