Originally Posted by soccertese

not yet recruiting in my area according to FOX TRIAL FINDER

Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)
Purpose:

This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.
Detailed Description

Treatment options for patients with motor response fluctuations (i.e., OFF episodes) are limited. Most commonly, OFF episodes are managed by adjusting the dose interval of their standard oral medications to minimize the burden of OFF symptoms, or to manage acute episodic OFF symptoms, by self-administration of unscheduled doses of oral Parkinson’s medication. Due to the variability in oral levodopa absorption, resumption of motor function following oral levodopa administration is unreliable and may be delayed for an hour or more. CVT-301 (levodopa inhalation powder) delivers levodopa through the lung using a simple inhaler, resulting in rapid and precise increases in levodopa blood levels, sufficient to enable rapid restoration in motor function for patients experiencing OFF episodes. This is a multi-centered, randomized, double-blind, controlled study to assess the safety and efficacy of inhaled CVT-301 compared to placebo both at home and in the clinic. Approximately 80 patients will be enrolled across sites in the United States, United Kingdom, Italy and Serbia. Patients will be trained on the proper use of the inhaler system as well as on the diaries that will be used to collect important efficacy data, including the ON/OFF treatment log and PD (Hauser) diary. Clinical safety (blood draws, vital signs [blood pressure, heart rate], ECGs, physical exam) will be monitored including spirometry to measure lung function. Motor assessments in the clinic will consist of determination of UPDRS Part 3 assessment, and time to ON state. On treatment visit days, patient will take their standard oral Parkinson's medication(s) before arriving to the clinic. After experiencing an OFF period in the clinic, patients will receive a single dose of study medication (inhaled placebo or CVT-301) on each of four separate treatment visits. Measures of motor response, safety and pulmonary function will be assessed at predetermined intervals. At home, patients will self-administer CVT-301 or placebo to treat up to 3 OFF episodes per day and complete each day an Inhaled Medication ON/OFF Log; patients will also record their ON/OFF status (time OFF, time ON without dyskinesia, time ON with non-troublesome dyskinesia, time ON with troublesome dyskinesia) and time asleep in their PD diary for 3 days prior to most clinic visits.