At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 351 enrolled
Drug / intervention
CVT-301 Low Dose +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)
In Brief
A Phase 3 clinical trial evaluating CVT-301 Low Dose, CVT-301 High Dose, and 1 other intervention for Idiopathic Parkinson's Disease. Completed, enrolled 351 participants across 74 sites in 5 countries.
Detailed Summary
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. Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Parkinson's Disease
CountriesCanada, Czechia, Poland, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartNov 2014
Primary CompletionDec 2016
TodayJul 2026
First PostedSep 15, 2014
Enrollment StartNov 1, 2014
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.8 years ago
Interventions
CVT-301 Low Dosedrug
CVT-301 High Dosedrug
Placeboother