An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

Phase 3

Completed

• Conditions: Advanced Stage Parkinson's Disease
• Interventions: Drug: Pardoprunox

• Registration Number: NCT00407095
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

This study is a multicenter, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.002 study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-11-30
• Study First Posted: 2006-12-04
• Study Start: 2007-08
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-10
• Last Update Posted: 2010-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Pardoprunox	-

Primary Outcome Measures

Name	Time	Method
Safety: laboratory data, adverse events, vital signs, ECG	36 weeks

Secondary Outcome Measures

Name	Time	Method
On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline	36 weeks

Trial Locations

Locations (87)

S308.3.007 Site # 221; 🇺🇸 Chicago, Illinois, United States

S308.3.007 Site # 120; 🇧🇬 Sofia, Bulgaria

S308.3.007 Site # 141; 🇨🇱 Santiago de Chile, Chile

S308.3.007 Site # 132; 🇨🇦 Markham, Canada

S308.3.007 Site # 118; 🇧🇷 Porto Alegre, Brazil

S308.3.007 Site # 106; 🇦🇷 Buenos Aires, Argentina

S308.3.007 Site # 134; 🇨🇦 Ottava, Canada

S308.3.007 Site # 114; 🇧🇷 Alto da Glória, Brazil

S308.3.007 Site # 215; 🇺🇸 Houston, Texas, United States

S308.3.007 Site # 111; 🇧🇷 Porto Alegre, Brazil

S308.3.007 Site # 104; 🇦🇷 Mar del Plata, Argentina

S308.3.007 Site # 109; 🇦🇷 Buenos Aires, Argentina

S308.3.007 Site # 210; 🇺🇸 Tledo, Ohio, United States

S308.3.007 Site # 223; 🇦🇱 Birmingham, Albania

S308.3.007 Site # 123; 🇧🇬 Plovdiv, Bulgaria

S308.3.007 Site # 137; 🇨🇦 Greenfield Park, Canada

S308.3.007 Site # 125; 🇧🇷 Sao Paulo, Brazil

S308.3.007 Site # 217; 🇺🇸 St. Louis, Missouri, United States

S308.3.007 Site # 124; 🇧🇬 Sofia, Bulgaria

S308.3.007 Site # 115; 🇧🇷 Sâo Paulo, Brazil

S308.3.007 Site # 136; 🇨🇦 Calgary, Canada

S308.3.007 Site # 122; 🇧🇬 Sofia, Bulgaria

S308.3.007 Site # 117; 🇧🇷 Ribeirão Preto, Brazil

S308.3.007 Site # 202; 🇺🇦 Kyiv, Ukraine

S308.3.007 Site # 195; 🇷🇺 Saint-Petersburg, Russian Federation

S308.3.007 Site # 206; 🇺🇦 Kharkiv, Ukraine

S308.3.007 Site # 203; 🇺🇦 Poltava, Ukraine

S308.3.007 Site # 207; 🇺🇦 Zaporozhya, Ukraine

S308.3.007 Site # 205; 🇺🇦 Lviv, Ukraine

S308.3.007 Site # 216; 🇺🇸 Kansas City, Kansas, United States

S308.3.007 Site # 150; 🇨🇴 Medellin, Colombia

S308.3.007 Site # 160; 🇱🇻 Riga, Latvia

S308.3.007 Site # 182; 🇵🇪 Lima, Peru

S308.3.007 Site # 143; 🇨🇱 Santiago de Chile, Chile

S308.3.007 Site # 151; 🇨🇴 Bogota, Colombia

S308.3.007 Site # 152; 🇨🇴 Bogota, Colombia

S308.3.007 Site # 196; 🇷🇺 Yaroslavl, Russian Federation

S308.3.007 Site # 204; 🇺🇦 Dnepropetrovsk, Ukraine

S308.3.007 Site # 201; 🇺🇦 Kyiv, Ukraine

S308.3.007 Site # 197; 🇷🇺 Moscow, Russian Federation

S308.3.007 Site # 142; 🇨🇱 Valdivia, Chile

S308.3.007 Site # 172; 🇱🇹 Kaunas, Lithuania

S308.3.007 Site # 190; 🇷🇺 Moscow, Russian Federation

S308.3.007 Site # 194; 🇷🇺 Moscow, Russian Federation

S308.3.007 Site # 208; 🇺🇦 Simferopol, Ukraine

S308.3.007 Site # 200; 🇺🇦 Vinnytsya, Ukraine

S308.3.007 Site # 119; 🇧🇷 Salvador, Brazil

S308.3.007 Site # 110; 🇧🇷 São Paulo, Brazil

S308.3.007 Site # 153; 🇨🇴 Bogota, Colombia

S308.3.007 Site # 211; 🇺🇸 San Francisco, California, United States

S308.3.007 Site # 218; 🇺🇸 Gainsville, Florida, United States

S308.3.007 Site # 222; 🇺🇸 Durham, North Carolina, United States

S308.3.007 Site # 213; 🇺🇸 Tampa, Florida, United States

S308.3.007 Site # 220; 🇺🇸 LaJolla, California, United States

S308.3.007 Site # 214; 🇺🇸 Fort Lauderdale, Florida, United States

S308.3.007 Site # 224; 🇺🇸 Lexington, Kentucky, United States

S308.3.007 Site # 219; 🇺🇸 Augusta, Georgia, United States

S308.3.007 Site # 212; 🇺🇸 East Lansing, Michigan, United States

S308.3.007 Site # 100; 🇦🇷 Buenos Aires, Argentina

S308.3.007 Site # 101; 🇦🇷 Buenos Aires, Argentina

S308.3.007 Site # 107; 🇦🇷 Buenos Aires, Argentina

S308.3.007 Site # 103; 🇦🇷 Buenos Aires, Argentina

S308.3.007 Site # 105; 🇦🇷 Córdoba, Argentina

S308.3.007 Site # 108; 🇦🇷 Santa Fe, Argentina

S308.3.007 Site # 112; 🇧🇷 Campinas, Brazil

S308.3.007 Site # 113; 🇧🇷 Belo Horizonte, Brazil

S308.3.007 Site # 116; 🇧🇷 Marília, Brazil

S308.3.007 Site # 121; 🇧🇬 Sofia, Bulgaria

S308.3.007 Site # 133; 🇨🇦 Halifax, Canada

S308.3.007 Site # 130; 🇨🇦 Montreal, Canada

S308.3.007 Site # 138; 🇨🇦 Peterborough, Canada

S308.3.007 Site # 135; 🇨🇦 Sainte-Anne, Canada

S308.3.007 Site # 131; 🇨🇦 Windsor, Canada

S308.3.007 Site # 139; 🇨🇦 Toronto, Canada

S308.3.007 Site # 140; 🇨🇱 Santiago de Chile, Chile

S308.3.007 Site # 154; 🇨🇴 Bogota, Colombia

S308.3.007 Site # 171; 🇱🇹 Vilnius, Lithuania

S308.3.007 Site # 184; 🇵🇪 Bellavista Callao, Peru

S308.3.007 Site # 170; 🇱🇹 Vilnius, Lithuania

S308.3.007 Site # 181; 🇵🇪 Lima, Peru

S308.3.007 Site # 180; 🇵🇪 Lima, Peru

S308.3.007 Site # 193; 🇷🇺 Kazan, Russian Federation

S308.3.007 Site # 183; 🇵🇪 Lima, Peru

S308.3.007 Site # 191; 🇷🇺 Saint-Petersburg, Russian Federation

S308.3.007 Site # 192; 🇷🇺 Saint-Petersburg, Russian Federation

S308.3.007 Site # 198; 🇷🇺 Saint-Petersburg, Russian Federation

S308.3.007 Site # 102; 🇦🇷 Buenos Aires, Argentina