Overview

This trial is active, not recruiting.

Condition idiopathic parkinson's disease
Treatment cvt-301
Phase phase 3
Sponsor Acorda Therapeutics
Start date November 2014
End date December 2016
Trial size 345 participants
Trial identifier NCT02240030, CVT-301-004

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 .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
cvt-301 Inhaled levodopa
(Experimental)
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
cvt-301 Inhaled levodopa
(Placebo Comparator)
Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
cvt-301 Inhaled levodopa

Primary Outcomes

Measure
Change from pre-dose in Unified Parkinson's Disease Rating Scale (UPDRS) Part III motor score at 30 minutes following treatment of patients experiencing an OFF episode
time frame: at week 12

Secondary Outcomes

Measure
Proportion of patients achieving resolution of an OFF to an ON state within 60 minutes.
time frame: at week 12
Change from pre-dose in UPDRS Part III motor score at 10 and 20 minutes following treatment of patients experiencing an OFF episode
time frame: at week 12
Safety (including pulmonary safety) and tolerability of CVT-301.
time frame: change from baseline through 3 months duration of outpatient use
Total daily OFF time and daily ON time ± dyskinesia (troublesome/nontroublesome)
time frame: change from baseline through 3 months duration of outpatient use
Effect of CVT-301 on activities of daily living and quality of life
time frame: change from baseline to 3 months duration of outpatient use

Eligibility Criteria

Male or female participants from 30 years up to 85 years old.

Inclusion Criteria: - Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 years; - Hoehn and Yahr Stage 1-3 in an "on" state; - Require levodopa-containing medication regimen at least 3 times during the waking day; - Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness; - Are on stable PD medication regimen; - Total daily LD dose <1600 mg/day; - Able to perform a spirometry maneuver in the ON and OFF states; - Normal cognition confirmed by MMSE score ≥25 Exclusion Criteria: - Pregnant or lactating females; - Previous surgery for PD or plan to have stereotactic surgery during the study period; - History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year; - Known contraindication to the use of levodopa; - Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety; - Any contraindication to performing routine spirometry.

Additional Information

Official title 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 ™)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Acorda Therapeutics.