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.

Most drugs that are amenable to be delivered via the lungs are highly active in microgram amounts. What is being suggested would cause havoc to the alveoli in the lungs. The absorption and clearance would just be too problematical at the doses needed for efficacy.

rial Design
The Phase 2 study (CVT
-
301
-
002) was a multicenter, randomized, double blind, placebo
-
controlled,
single dose, cross
-
over design with three arms (placebo, 25mg and 50mg) and included an “open label”
oral Sinemet arm. The twenty four (24) patients treated i
n this study underwent serial evaluations of L
-
dopa plasma levels, motor response, and safety at each visit. The patients were administered the study
drug in the OFF state with the serial evaluations starting prior to dosing and continuing for up to 180
m
inutes post
-
dose. Motor function was measured using a tapping test, the Unified Parkinson’s Disease
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used small doses, appears to be intended to be used as a rescue drug kind of like apomorphine(?) injections? more gets to the brain since bypasses digestive system.
i imagine a lot of advanced pd'ers need something like this, i know i could use it just to give me more confidence to get out and about and not have to worry as much about wearing off since i'm not taking a longer acting agonist. i doubt anyone could afford it as a primary treatment.
http://civitastherapeutics.com/cms/s...3%200419_1.pdf