Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes

Phase 3

Completed

• Conditions: Idiopathic Parkinson's Disease
• Interventions: Drug: CVT-301 Low Dose; Other: Placebo; Drug: CVT-301 High Dose

• Registration Number: NCT02240030
• Lead Sponsor: Acorda Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Study Start: 2014-11
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2018-01-23
• Results First Submitted QC: 2018-03-15
• Results First Posted: 2018-04-17
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CVT-301 Low Dose	CVT-301 Low Dose	Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
Placebo	Placebo	Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
CVT-301 High Dose	CVT-301 High Dose	Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration

Primary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (UPDRS) Part III	30 minutes post-dose at week 12	Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.	at week 12	Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed
UPDRS Part III Motor Score at 20 Minutes	at week 12	Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12	week 12	Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better.
UPDRS Part III at 10 Min.	week 12	Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
PD Patient Diary	post week 12	Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours.

Trial Locations

Locations (74)

Acorda Site #5301; 🇵🇱 Warsaw, Poland

Acorda Site #5053; 🇺🇸 Aventura, Florida, United States

Acorda Site #5044; 🇺🇸 Orlando, Florida, United States

Acorda Site #5060; 🇺🇸 Palm Beach Gardens, Florida, United States

Acorda Site #5069; 🇺🇸 Torrance, California, United States

Acorda Site #5057; 🇺🇸 Baltimore, Maryland, United States

Acorda Site #5006; 🇺🇸 Saint Louis, Missouri, United States

Acorda Site #5025; 🇺🇸 Chicago, Illinois, United States

Acorda Site #5071; 🇺🇸 Maitland, Florida, United States

Acorda Site #5059; 🇺🇸 Virginia Beach, Virginia, United States

Acorda Site #5004; 🇺🇸 New York, New York, United States

Acorda Site #5105; 🇨🇦 Toronto, Ontario, Canada

Acorda Site #5065; 🇺🇸 Saint Petersburg, Florida, United States

Acorda Site #5036; 🇺🇸 Allentown, Pennsylvania, United States

Acorda Site #5307; 🇵🇱 Kraków, Poland

Acorda Site #5040; 🇺🇸 Atlanta, Georgia, United States

Acorda Site #5103; 🇨🇦 London, Ontario, Canada

Acorda Site #5407; 🇪🇸 Pamplona, Navarre, Spain

Acorda Site #5039; 🇺🇸 Brooklyn, New York, United States

Acorda Site #5068; 🇺🇸 Santa Ana, California, United States

Acorda Site #5013; 🇺🇸 Boca Raton, Florida, United States

Acorda Site #5038; 🇺🇸 Syracuse, New York, United States

Acorda Site #5047; 🇺🇸 Reseda, California, United States

Acorda Site #5031; 🇺🇸 New York, New York, United States

Acorda Site #5303; 🇵🇱 Krakow, Poland

Acorda Site #5067; 🇺🇸 Baton Rouge, Louisiana, United States

Acorda Site #5203; 🇨🇿 Prague, Czechia

Acorda Site #5028; 🇺🇸 Albany, New York, United States

Acorda Site #5201; 🇨🇿 Prague, Czechia

Acorda Site #5304; 🇵🇱 Katowice, Poland

Acorda Site #5104; 🇨🇦 Ottawa, Ontario, Canada

Acorda Site #5050; 🇺🇸 Norwood, Ohio, United States

Acorda Site #5302; 🇵🇱 Lodz, Poland

Acorda Site #5404; 🇪🇸 Barcelona, Spain

Acorda Site #5306; 🇵🇱 Kraków, Poland

Acorda Site #5005; 🇺🇸 Cleveland, Ohio, United States

Acorda Site #5045; 🇺🇸 Houston, Texas, United States

Acorda Site #5403; 🇪🇸 San Sebastián, Spain

Acorda Site #5405; 🇪🇸 Madrid, Spain

Acorda Site #5056; 🇺🇸 Boston, Massachusetts, United States

Acorda Site #5023; 🇺🇸 Las Vegas, Nevada, United States

Acorda Site #5019; 🇺🇸 Houston, Texas, United States

Acorda Site #5003; 🇺🇸 Kansas City, Kansas, United States

Acorda Site #5029; 🇺🇸 Nashville, Tennessee, United States

Acorda Site #5062; 🇺🇸 Portland, Oregon, United States

Acorda Site #5070; 🇺🇸 Pasadena, California, United States

Acorda Site #5037; 🇺🇸 Los Angeles, California, United States

Acorda Site #5035; 🇺🇸 Loma Linda, California, United States

Acorda Site #5020; 🇺🇸 Scottsdale, Arizona, United States

Acorda Site #5064; 🇺🇸 Fullerton, California, United States

Acorda Site #5027; 🇺🇸 Long Beach, California, United States

Acorda Site #5042; 🇺🇸 Fresno, California, United States

Acorda Site #5016; 🇺🇸 Jacksonville, Florida, United States

Acorda Site #5046; 🇺🇸 Atlantis, Florida, United States

Acorda Site #5001; 🇺🇸 Port Charlotte, Florida, United States

Acorda Site #5030; 🇺🇸 Chicago, Illinois, United States

Acorda Site #5012; 🇺🇸 Tampa, Florida, United States

Acorda Site #5002; 🇺🇸 Bingham Farms, Michigan, United States

Acorda Site #5011; 🇺🇸 Elk Grove Village, Illinois, United States

Acorda Site #5018; 🇺🇸 Boston, Massachusetts, United States

Acorda Site #5014; 🇺🇸 West Bloomfield, Michigan, United States

Acorda Site #5041; 🇺🇸 Golden Valley, Minnesota, United States

Acorda Site #5032; 🇺🇸 New York, New York, United States

Acorda Site #5010; 🇺🇸 Philadelphia, Pennsylvania, United States

Acorda Site #5058; 🇺🇸 Willow Grove, Pennsylvania, United States

Acorda Site #5049; 🇺🇸 Henrico, Virginia, United States

Acorda Site #5308; 🇵🇱 Warsaw, Poland

Acorda Site #5305; 🇵🇱 Zaspa, Poland

Acorda Site #5401; 🇪🇸 Sant Cugat Del Vallès, Spain

Acorda Site #5052; 🇺🇸 Washington, District of Columbia, United States

Acorda Site #5048; 🇺🇸 Charlotte, North Carolina, United States

Acorda Site #5022; 🇺🇸 Charleston, South Carolina, United States

Acorda Site #5051; 🇺🇸 Kirkland, Washington, United States

Acorda Site #5406; 🇪🇸 Barcelona, Spain