The purpose of this study is to determine the safety, efficacy and pharmacokinetics following administration of CVT-301 in treatment of "off" episodes in Parkinson's Disease patients.
Treatment options for patients with motor response fluctuations are limited. Most commonly, "off" episodes are managed by adjusting the dose interval of their standard oral medications or by self-administration of unscheduled doses of oral Parkinson's medication. Due to the variability in levodopa absorption following oral dosing, resumption of motor function is unreliable and may be delayed for an hour or more. CVT-301 delivers levodopa using a simple inhaler, resulting in rapid increases in levodopa blood levels and is expected to result in rapid restoration in motor function for patients experiencing "off" episodes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Civitas Clinical Site #6
Petah Tikva, Israel
Civitas Clinical Site #5
Tel Aviv, Israel
Civitas Clinical Site #4
Belgrade, Serbia
Civitas Clinical Site #7
Belgrade, Serbia
Safety
Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function
Time frame: change from baseline up to 13 weeks
Pharmacodynamics
Time to onset of meaningful "on" and "off" states (patient- and examiner-assessed) UPDRS III motor score Tapping test Dyskinesia
Time frame: 3 hours post-dose
Pharmacokinetics
Serial blood draw for determination of plasma concentration-time profile
Time frame: 3 hours post-dose
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Civitas Clinical Site #1
Glasgow, United Kingdom
Civitas Clinical Site #3
Newcastle, United Kingdom
Civitas Clinical Site #2
Norwich, United Kingdom