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

Idiopathic Parkinson's Disease Clinical Trial

Official title:

A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242487
• Other study ID #: CVT-301-004E
• Status: Completed
• Phase: Phase 3
• Start date: March 2015
• Est. completion date: May 2018

Study information

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

Clinical Trial Summary

This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes). All patients will receive active treatment, but patients will be blinded to dose level. This will serve as an extension to the CVT-301-004 (NCT02240030) study for those patients who participated in that study and remain eligible for this study. In addition, patients who previously completed the CVT-301-003 (NCT01777555), CVT-301-009 (NCT02807675) and CVT-301-005 (NCT02352363) (observational arm completers), as well as CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 86 Years

Eligibility

Inclusion Criteria:

• Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 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 levodopa (LD) dose <1600 mg/day;

• Able to perform a spirometry maneuver in the ON and OFF states

• Normal cognition confirmed by Mini Mental State Examination (MMSE) score =25 ;

Exclusion Criteria:

• Pregnant or lactating females;

• Previous surgery for PD or plan to have stereotactic surgery during the study period. Patients who have had deep brain stimulation [DBS] will also be excluded unless the procedure was performed more than 6 months prior to study enrollment.

• 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 any contraindication to performing routine spirometry.

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• CVT-301

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 #5305	Gdansk	Zappa
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
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	Pulmonary Safety of CVT-301 Change From Baseline for FEV1.	To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1 (forced expiratory volume in 1 second) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.	Change from baseline at 52 weeks
Primary	Pulmonary Safety for CVT-301 Change From Baseline for FVC.	To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FVC, (forced vital capacity) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.	Change from baseline at 52 weeks
Primary	Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).	To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1/FVC (FEV1-forced expiratory volume in 1 second and (FVC) forced vital capacity ratio) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.	Change from baseline at 52 weeks
Secondary	Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.	Count of patients achieving resolution of an OFF to an ON state within 60 minutes after study drug is administered in the clinic, and maintaining the ON state at 60 minutes after study drug administration (per the examiner's subjective assessment).	At Treatment Visit - TV6 (Week 52)
Secondary	Change From Baseline in OFF Time.	Patient reported total daily OFF time and was assessed by the patient and recorded in the patient Diary. An "OFF state" is defined as the time when medication is not providing benefit with respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms. Patients will record their ON and OFF states in their diaries at home.	Change from baseline through 12 months duration of outpatient use

External Links

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