An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients

Condition(s) targeted: Early Stage Parkinson's Disease

Intervention: SLV308 (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308. 3.001 trial

Official title: An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Patients who have completed S308. 3.001 trial Exclusion Criteria: Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308. 3.001

Site 200, Buenos Aires, Argentina

Site 201, Buenos Aires, Argentina

Site 202, Buenos Aires, Argentina

Site 203, Ciudad Autonoma de Buenos Aires, Argentina

Site 204, Buenos Aires, Argentina

Site 205, Cordoba, Argentina

Site 206, Buenos Aires, Argentina

Site 207, Ciudad de Buenos Aires, Argentina

Site 208, Capital Federal, CBA, Argentina

Site 100, Brussels, Belgium

Site 101, Genk, Belgium

Site 102, Wilrijk, Belgium

Site 103, Sofia, Bulgaria

Site 104, Sofia, Bulgaria

Site 105, Sofia, Bulgaria

Site 106, Sofia, Bulgaria

Site 107, Plovdiv, Bulgaria

Site 260, Calgary, Canada

Site 261, Ottawa, Canada

Site 262, Quebec, Canada

Site 263, Markham, Canada

Site 264, Greenfield Park, Canada

Site 265, Quebec, Canada

Site 266, Ottawa, Canada

Site 267, Toronto, Canada

Site 268, Barrie, Canada

Site 269, Saskatoon, Canada

Site 210, Santiago de Chile, Chile

Site 211, San Miguel, Chile

Site 212, Valdivia, Chile

Site 213, Providencia, Chile

Site 220, Medellin, Colombia

Site 221, Bogota, Colombia

Site 222, Cali, Colombia

Site 223, Bogota, Colombia

Site 224, Bogota, Colombia

Site 110, Zagreb, Croatia

Site 111, Rijeka, Croatia

Site 112, Split, Croatia

Site 113, Zagreb, Croatia

Site 114, Zagreb, Croatia

Site 120, Oulun yliopisto, Finland

Site 121, Tampere, Finland

Site 122, Lappeenranta, Finland

Site 123, Kuopio, Finland

Site 124, Turku, Finland

Site 193, Mumbai, India

Site 194, Hyderabaad, India

Site 195, Mumbai, India

Site 196, Bangalore, India

Site 197, Visakhapatnam, India

Site 198, Thiruvananthapuram, India

Site 199, New Delhi, India

Site 130, Tel Aviv, Israel

Site 131, Haifa, Israel

Site 132, Petach-Tikva, Israel

Site 133, Ramat-Gan, Israel

Site 230, Guadalajara - Jalisco, Mexico

Site 231, Monterrey N.L., Mexico

Site 232, Aguascalientes, Mexico

Site 233, Tlalpan, Mexico

Site 190, Wellington South, New Zealand

Site 191, Christchurch, New Zealand

Site 240, Lima, Peru

Site 241, La Victoria-Lima, Peru

Site 242, Surco-Lima, Peru

Site 243, San Isidro-Lima, Peru

Site 244, Barrios Altos-Lima, Peru

Site 140, Bucuresti, Romania

Site 141, Craiova, Romania

Site 142, Mures, Romania

Site 143, Brasov, Romania

Site 150, Moscow, Russian Federation

Site 151, Moscow, Russian Federation

Site 152, St. Petersburg, Russian Federation

Site 153, Yaroslav, Russian Federation

Site 154, Moscow, Russian Federation

Site 155, Smolensk, Russian Federation

Site 156, Moscow, Russian Federation

Site 157, St. Petersburg, Russian Federation

Site 158, Kazan, Russian Federation

Site 159, St Petersburg, Russian Federation

Site 160, Belgrade, Serbia and Montenegro

Site 161, Belgrade, Serbia and Montenegro

Site 162, Belgrade, Serbia and Montenegro

Site 163, Nis, Serbia and Montenegro

Site 170, Bratislava, Slovakia

Site 171, Bratislava, Slovakia

Site 172, Zilina, Slovakia

Site 173, Nitra, Slovakia

Site 174, Levice, Slovakia

Site 250, Cape Town, South Africa

Site 251, Durban, South Africa

Site 252, Cape Town, South Africa

Site 253, Gauteng, South Africa

Site 254, Pretoria, South Africa

Site 125, Stockholm, Sweden

Site 126, Norrkoping, Sweden

Site 127, Goteborg, Sweden

Site 180, Kharkiv, Ukraine

Site 181, Kyiv, Ukraine

Site 182, Kyiv, Ukraine

Site 183, Kharkiv, Ukraine

Site 184, Vinnitsa, Ukraine

Site 185, Lviv, Ukraine

Site 284, Huntsville, Alabama, United States

Site 274, Little Rock, Arkansas, United States

Site 271, San Francisco, California, United States

Site 277, La Jolla, California, United States

Site 283, Fountain Valley, California, United States

Site 273, Tampa, Florida, United States

Site 279, Ft Lauderdale, Florida, United States

Site 282, Port Charlotte, Florida, United States

Site 285, Sunrise, Florida, United States

Site 293, Gainsville, Florida, United States

Site 290, Chicago, Illinois, United States

Site 280, Kansas City, Kansas, United States

Site 275, Traverse City, Michigan, United States

Site 292, Bingham Farms, Michigan, United States

Site 276, St. Louis, Missouri, United States

Site 287, St. Louis, Missouri, United States

Site 278, Las Vegas, Nevada, United States

Site 286, Rochester, New York, United States

Site 288, Ashville, North Carolina, United States

Site 289, Charlotte, North Carolina, United States

Site 294, Toledo, Ohio, United States

Site 281, Pittsburgh, Pennsylvania, United States

Site 291, Warwick, Rhode Island, United States

Site 272, Houston, Texas, United States

Site 270, Bennington, Vermont, United States

Starting date: February 2007
Last updated: November 9, 2007