Randomized Safety Study of CVT-301 Compared to an Observational Control Group

Idiopathic Parkinson's Disease Clinical Trial

Official title:

A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352363
• Other study ID #: CVT-301-005
• Status: Completed
• Phase: Phase 3
• Start date: March 2015
• Est. completion date: May 2017

Study information

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

Clinical Trial Summary

This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.

Description:

A randomized, double-blind, placebo-controlled, Phase 2b study in patients with PD (CVT-301-003) demonstrated clinically important, and statistically significant CVT-301-associated improvements in motor function at doses of 35 and 50 mg LD FPD, compared with placebo, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) motor assessment (Part 3); furthermore, CVT-301 was generally safe and well tolerated. A Phase 3, randomized, placebo-controlled study designed to assess the efficacy and safety of 35 mg and 50 mg FPD as an adjunct to a CD/LD regimen in the treatment of OFF symptoms over 12 weeks (CVT-301-004) was conducted in parallel with this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• ?Has signed and dated an Internal Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form before any protocol-specific screening procedures are performed.

• Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study.

• Patients who have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years.

• Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.

• Patients who have experienced motor fluctuations for a minimum of 2 hours of average daily OFF time per waking day (excluding early morning OFF time) by self-report and confirmed by the PD Diary (on 3 consecutive days) during the screening period.

Exclusion Criteria:

• Patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.

• Pregnant or lactating females or females wishing to become pregnant.

• Patients who have any known contraindication to the use of levodopa (LD), including a history of malignant melanoma or a history of narrow-angle glaucoma.

• Patients who have had previous surgery for PD (including but not limited to deep brain stimulation [DBS] or cell transplantation).

• Patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months.

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• CVT-301

Other:
• Observational cohort

Locations

Country	Name	City	State
Austria	Acorda Site #7004	Innsbruck
Austria	Acorda Site #7002	Linz
Austria	Acorda Site #7003	Vienna
Belgium	Acorda Site #7011	Brussels
Belgium	Acorda Site #7012	Edegem
Belgium	Acorda Site #7013	Ghent
Czechia	Acorda Site #7024	Chocen
Czechia	Acorda Site #7025	Ostrava
Czechia	Acorda Site #7021	Pardubice
Czechia	Acorda Site #7022	Prague 10
Czechia	Acorda Site #7023	Rychnov nad Kneznou
France	Acorda Site #7036	Amiens
France	Acorda Site #7037	Bordeaux
France	Acorda Site #7034	Marseille Cedex 05
France	Acorda Site #7031	MONTPELLIER Cedex 5
France	Acorda Site #7033	Nimes Cedex
France	Acorda Site #7032	Strasbourg
France	Acorda Site #7035	Toulouse Cedex 9
Germany	Acorda Site #7041	Achim
Germany	Acorda Site #7043	Beelitz-Heilstätten
Germany	Acorda Site #7049	Berlin
Germany	Acorda Site #7050	Bochum
Germany	Acorda Site #7048	Bremerhaven
Germany	Acorda Site #7047	Cologne
Germany	Acorda Site #7046	Marburg
Germany	Acorda Site #7042	Munich
Germany	Acorda Site #7044	Ulm
Hungary	Acorda Site #7051	Budapest
Hungary	Acorda Site #7053	Budapest
Israel	Acorda Site #7062	Jerusalem
Israel	Acorda Site #7064	Petah Tikva
Israel	Acorda Site #7061	Ramat Gan
Israel	Acorda Site #7063	Tel-Aviv
Netherlands	Acorda Site #7045	Den Haag
Poland	Acorda Site #7085	Gdansk
Poland	Acorda Site #7084	Katowice
Poland	Acorda Site #7083	Kracow
Poland	Acorda Site #7086	Kraków
Poland	Acorda Site #7087	Kraków
Poland	Acorda Site #7082	Lodz
Poland	Acorda Site #7081	Warsaw
Poland	Acorda Site #7088	Warsaw
Romania	Acorda Site #7092	Brasov
Romania	Acorda Site #7094	Brasov
Romania	Acorda Site #7093	Bucharest
Romania	Acorda Site #7091	Constanta
Romania	Acorda Site #7095	Targu Mures
Serbia	Acorda Site #7101	Belgrade
Serbia	Acorda Site #7102	Belgrade
Serbia	Acorda Site #7103	Kragujevac
Spain	Acorda Site #7111	Barcelona
Spain	Acorda Site #7116	Barcelona
Spain	Acorda Site #7119	Barcelona
Spain	Acorda Site #7120	Barcelona
Spain	Acorda Site #7113	Burgos
Spain	Acorda Site #7114	Madrid
Spain	Acorda Site #7118	Madrid
Spain	Acorda Site #7115	San Sebastian
Spain	Acorda Site #7112	Sant Cugat	Barcelona
United Kingdom	Acorda Site #7123	Cambridge
United Kingdom	Acorda Site #7121	Glasgow
United Kingdom	Acorda Site #7122	London
United States	Acorda Site #7133	Atlanta	Georgia
United States	Acorda Site #7134	Atlanta	Georgia
United States	Acorda Site #7150	Baton Rouge	Louisiana
United States	Acorda Site #7131	Decatur	Georgia
United States	Acorda Site #7140	Des Moines	Iowa
United States	Acorda Site # 7142	Fountain Valley	California
United States	Acorda Site #7138	Honolulu	Hawaii
United States	Acorda Site #7137	Ormond Beach	Florida
United States	Acorda Site #7139	Panorama City	California
United States	Acorda Site #7135	Saint Petersburg	Florida
United States	Acorda Site #7145	Scottsdale	Arizona
United States	Acorda Site #7141	Sunnyvale	California
United States	Acorda Site #7130	Sunrise	Florida
United States	Acorda Site #7148	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Czechia,  France,  Germany,  Hungary,  Israel,  Netherlands,  Poland,  Romania,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]	To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second [FEV1], over a 12 month period.	Month 12 reported
Primary	Pulmonary Safety Assessed by Forced Vital Capacity [FVC].	To characterize the pulmonary safety, as assessed by spirometry (forced vital capacity).	Month 12 reported
Primary	Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.	To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second / forced vital capacity ratio).	Month 12 reported
Secondary	Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).	To describe the effects of CVT-301 on diffusion capacity of the lungs for carbon monoxide (DLco) over a 12-month period.	Month 12 reported

External Links

•   Click here for more information about this study:CVT-301-005