Rapid relief of motor fluctuations in parkinson's disease
A technology for Parkinson's disease and dyskinesia, which is applied in the field of rapidly reducing motor fluctuations in Parkinson's disease, and can solve problems such as reduced dopamine storage capacity
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Embodiment 1
[0112] summary
[0113] A 90 / 8 / 2 dry powder levodopa formulation is provided to evaluate the safety, tolerability, and levodopa following administration of 90 / 8 / 2 pulmonary levodopa powder compared with oral levodopa in adult healthy volunteers Bar pharmacokinetics (PK). The pulmonary levodopa powder described in these examples comprises granules of 90% levodopa, 8% dipalmitoylphosphatidylcholine, and 2% sodium chloride (all by dry weight), and is referred to herein as for 90 / 8 / 2. The data provide a description of the PK of levodopa after a single inhaled dose of 90 / 8 / 2 and a comparison with oral administration of levodopa (LD) under fasted or fed conditions, and with and without carbidol Comparison of PK of bar (CD) pretreatment. This is a two-part study in healthy adult male and female subjects as follows: Part A - dose escalation phase compared to oral levodopa; part B - 90 / 8 / 2 plus or minus carbidopa pre-treatment treatment phase.
[0114] Part A is an open-label, 3...
Embodiment 2
[0206]The Phase 2 study testing two doses of pulmonary levodopa (25 mg and 50 mg of study drug) was a multicenter, randomized, double-blind, placebo-controlled, single-dose, crossover design with three arms (placebo, 25 mg and 50 mg) and included the "open label" oral Sinemet arm. The 24 PD (24) patients treated in this study were serially assessed at each visit for L-dopa plasma levels, motor response and safety. Patients were administered study drug in the OFF state, with serial assessments beginning pre-dose and continuing through 180 minutes post-dose. Motor function was measured using the tap test, the Unified Parkinson's Disease Rating Scale Part III (UPDRS III), and subjective assessment of "meaningful" NO and OFF. Safety parameters monitored included lung function, clinical laboratory data, EGC, and vital signs (blood pressure, heart rate, and orthostatic blood pressure). This study was designed to measure the timing, magnitude, and persistence of the effects of pulm...
Embodiment 3
[0209] Phase 2(b) randomized, double-blind placebo-controlled study
[0210] Phase 2b study design and methods utilizing 90 / 8 / 2
[0211] This study is a study of inhaled (inhaled levodopa [LD] powder) or placebo for the treatment of up to 3 OFF episodes per day in Parkinson's disease (PD) subjects experiencing motor fluctuations (OFF episodes). Randomized, double-blind, placebo-controlled multicentre study. Subjects were randomly assigned in a 1:1 ratio to receive inhaled 90 / 8 / 2 (also referred to herein as "study drug") or placebo; through subjects' Hoehn and Yahr stages (<2.5 versus ≥2.5 ) grades to balance the severity of disease in each group.
[0212] 90 / 8 / 2LD FPD comprises uniform granules containing 90% LD, 8% dipalmitoylphosphatidylcholine (DPPC) and 2% sodium chloride (NaCl). 90 / 8 / 2 was delivered using an inhaler device for powder inhalation as described in US Patent No. 8,496,002, which is incorporated herein by reference. 90 / 8 / 2 are supplied in size 00 hypromello...
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