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news.Neuraltus Pharmaceuticals has revealed results from a double blinded, placebo controlled, Phase 1/2 clinical study of NP002 for the treatment of dyskinesias (muscle movement disorders) resulting from levodopa therapy for patients with parkinson's disease.
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NP002 is a small molecule, orally available nicotinic receptor agonist that has been shown in preclinical studies to reduce LIDs without affecting parkinsonian symptoms.
Neuraltus Pharma said the Phase 1/2 study was performed to investigate the safety and tolerability of NP002 in a total of 65 individuals with parkinson’s disease and documented LIDs.
In the trial, NP002 administered concurrently with levodopa treatment was found to be generally safe and well-tolerated in Parkinson’s patients with LIDs.
In addition, 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.
The primary objective of the 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).
Parkinson Institute scientific director and CEO William Langston said in particular, the study showed a significant trend in improvement in the objective UDRS scale and results on the PGIC scale, which measures how patients feel overall, suggesting an improvement in quality of life.