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

Idiopathic Parkinson's Disease Clinical Trial

— SPAN-PD™  

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™)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240030
• Other study ID #: CVT-301-004
• Status: Completed
• Phase: Phase 3
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2019
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• CVT-301 Low Dose

• CVT-301 High Dose

Other:
• Placebo

Locations

Country	Name	City	State
Canada	Acorda Site #5103	London	Ontario
Canada	Acorda Site #5104	Ottawa	Ontario
Canada	Acorda Site #5105	Toronto	Ontario
Czechia	Acorda Site #5201	Prague
Czechia	Acorda Site #5203	Prague
Poland	Acorda Site #5304	Katowice
Poland	Acorda Site #5303	Krakow
Poland	Acorda Site #5306	Kraków
Poland	Acorda Site #5307	Kraków
Poland	Acorda Site #5302	Lodz
Poland	Acorda Site #5301	Warsaw
Poland	Acorda Site #5308	Warsaw
Poland	Acorda Site #5305	Zaspa
Spain	Acorda Site #5404	Barcelona
Spain	Acorda Site #5406	Barcelona
Spain	Acorda Site #5405	Madrid
Spain	Acorda Site #5407	Pamplona	Navarre
Spain	Acorda Site #5403	San Sebastián
Spain	Acorda Site #5401	Sant Cugat Del Vallès
United States	Acorda Site #5028	Albany	New York
United States	Acorda Site #5036	Allentown	Pennsylvania
United States	Acorda Site #5040	Atlanta	Georgia
United States	Acorda Site #5046	Atlantis	Florida
United States	Acorda Site #5053	Aventura	Florida
United States	Acorda Site #5057	Baltimore	Maryland
United States	Acorda Site #5067	Baton Rouge	Louisiana
United States	Acorda Site #5002	Bingham Farms	Michigan
United States	Acorda Site #5013	Boca Raton	Florida
United States	Acorda Site #5018	Boston	Massachusetts
United States	Acorda Site #5056	Boston	Massachusetts
United States	Acorda Site #5039	Brooklyn	New York
United States	Acorda Site #5022	Charleston	South Carolina
United States	Acorda Site #5048	Charlotte	North Carolina
United States	Acorda Site #5025	Chicago	Illinois
United States	Acorda Site #5030	Chicago	Illinois
United States	Acorda Site #5005	Cleveland	Ohio
United States	Acorda Site #5011	Elk Grove Village	Illinois
United States	Acorda Site #5042	Fresno	California
United States	Acorda Site #5064	Fullerton	California
United States	Acorda Site #5041	Golden Valley	Minnesota
United States	Acorda Site #5049	Henrico	Virginia
United States	Acorda Site #5019	Houston	Texas
United States	Acorda Site #5045	Houston	Texas
United States	Acorda Site #5016	Jacksonville	Florida
United States	Acorda Site #5003	Kansas City	Kansas
United States	Acorda Site #5051	Kirkland	Washington
United States	Acorda Site #5023	Las Vegas	Nevada
United States	Acorda Site #5035	Loma Linda	California
United States	Acorda Site #5027	Long Beach	California
United States	Acorda Site #5037	Los Angeles	California
United States	Acorda Site #5071	Maitland	Florida
United States	Acorda Site #5029	Nashville	Tennessee
United States	Acorda Site #5004	New York	New York
United States	Acorda Site #5031	New York	New York
United States	Acorda Site #5032	New York	New York
United States	Acorda Site #5050	Norwood	Ohio
United States	Acorda Site #5044	Orlando	Florida
United States	Acorda Site #5060	Palm Beach Gardens	Florida
United States	Acorda Site #5070	Pasadena	California
United States	Acorda Site #5010	Philadelphia	Pennsylvania
United States	Acorda Site #5001	Port Charlotte	Florida
United States	Acorda Site #5062	Portland	Oregon
United States	Acorda Site #5047	Reseda	California
United States	Acorda Site #5006	Saint Louis	Missouri
United States	Acorda Site #5065	Saint Petersburg	Florida
United States	Acorda Site #5068	Santa Ana	California
United States	Acorda Site #5020	Scottsdale	Arizona
United States	Acorda Site #5038	Syracuse	New York
United States	Acorda Site #5012	Tampa	Florida
United States	Acorda Site #5069	Torrance	California
United States	Acorda Site #5059	Virginia Beach	Virginia
United States	Acorda Site #5052	Washington	District of Columbia
United States	Acorda Site #5014	West Bloomfield	Michigan
United States	Acorda Site #5058	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Parkinson's Disease Rating Scale (UPDRS) Part III	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.	30 minutes post-dose at week 12
Secondary	Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.	Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed	at week 12
Secondary	UPDRS Part III Motor Score at 20 Minutes	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.	at week 12
Secondary	Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at 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.	week 12
Secondary	UPDRS Part III at 10 Min.	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.	week 12
Secondary	PD Patient Diary	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.	post week 12

External Links

•   Click here for more information about this study: CVT-301-004