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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02352363
Other study ID # CVT-301-005
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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