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

NCT ID: NCT00407095

Last Updated: 2010-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Advanced Stage Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Pardoprunox

Intervention Type DRUG

12-42 mg/day

Interventions

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Pardoprunox

12-42 mg/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria Patients who have completed S308.3.

Exclusion Criteria

002 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 S308.3.002
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Erik Vanleeuwen

Role: STUDY_DIRECTOR

Abbott Products

Locations

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S308.3.007 Site # 220

La Jolla, California, United States

Site Status

S308.3.007 Site # 211

San Francisco, California, United States

Site Status

S308.3.007 Site # 214

Fort Lauderdale, Florida, United States

Site Status

S308.3.007 Site # 218

Gainsville, Florida, United States

Site Status

S308.3.007 Site # 213

Tampa, Florida, United States

Site Status

S308.3.007 Site # 219

Augusta, Georgia, United States

Site Status

S308.3.007 Site # 221

Chicago, Illinois, United States

Site Status

S308.3.007 Site # 216

Kansas City, Kansas, United States

Site Status

S308.3.007 Site # 224

Lexington, Kentucky, United States

Site Status

S308.3.007 Site # 212

East Lansing, Michigan, United States

Site Status

S308.3.007 Site # 217

St Louis, Missouri, United States

Site Status

S308.3.007 Site # 222

Durham, North Carolina, United States

Site Status

S308.3.007 Site # 210

Tledo, Ohio, United States

Site Status

S308.3.007 Site # 215

Houston, Texas, United States

Site Status

S308.3.007 Site # 223

Birmingham, , Albania

Site Status

S308.3.007 Site # 100

Buenos Aires, , Argentina

Site Status

S308.3.007 Site # 101

Buenos Aires, , Argentina

Site Status

S308.3.007 Site # 102

Buenos Aires, , Argentina

Site Status

S308.3.007 Site # 103

Buenos Aires, , Argentina

Site Status

S308.3.007 Site # 106

Buenos Aires, , Argentina

Site Status

S308.3.007 Site # 107

Buenos Aires, , Argentina

Site Status

S308.3.007 Site # 109

Buenos Aires, , Argentina

Site Status

S308.3.007 Site # 105

Córdoba, , Argentina

Site Status

S308.3.007 Site # 104

Mar del Plata, , Argentina

Site Status

S308.3.007 Site # 108

Santa Fe, , Argentina

Site Status

S308.3.007 Site # 114

Alto da Glória, , Brazil

Site Status

S308.3.007 Site # 113

Belo Horizonte, , Brazil

Site Status

S308.3.007 Site # 112

Campinas, , Brazil

Site Status

S308.3.007 Site # 116

Marília, , Brazil

Site Status

S308.3.007 Site # 111

Porto Alegre, , Brazil

Site Status

S308.3.007 Site # 118

Porto Alegre, , Brazil

Site Status

S308.3.007 Site # 117

Ribeirão Preto, , Brazil

Site Status

S308.3.007 Site # 119

Salvador, , Brazil

Site Status

S308.3.007 Site # 115

Sâo Paulo, , Brazil

Site Status

S308.3.007 Site # 110

São Paulo, , Brazil

Site Status

S308.3.007 Site # 125

São Paulo, , Brazil

Site Status

S308.3.007 Site # 123

Plovdiv, , Bulgaria

Site Status

S308.3.007 Site # 120

Sofia, , Bulgaria

Site Status

S308.3.007 Site # 121

Sofia, , Bulgaria

Site Status

S308.3.007 Site # 122

Sofia, , Bulgaria

Site Status

S308.3.007 Site # 124

Sofia, , Bulgaria

Site Status

S308.3.007 Site # 136

Calgary, , Canada

Site Status

S308.3.007 Site # 137

Greenfield Park, , Canada

Site Status

S308.3.007 Site # 133

Halifax, , Canada

Site Status

S308.3.007 Site # 132

Markham, , Canada

Site Status

S308.3.007 Site # 130

Montreal, , Canada

Site Status

S308.3.007 Site # 134

Ottawa, , Canada

Site Status

S308.3.007 Site # 138

Peterborough, , Canada

Site Status

S308.3.007 Site # 135

Sainte-Anne, , Canada

Site Status

S308.3.007 Site # 139

Toronto, , Canada

Site Status

S308.3.007 Site # 131

Windsor, , Canada

Site Status

S308.3.007 Site # 140

Santiago, , Chile

Site Status

S308.3.007 Site # 141

Santiago, , Chile

Site Status

S308.3.007 Site # 143

Santiago, , Chile

Site Status

S308.3.007 Site # 142

Valdivia, , Chile

Site Status

S308.3.007 Site # 151

Bogotá, , Colombia

Site Status

S308.3.007 Site # 152

Bogotá, , Colombia

Site Status

S308.3.007 Site # 153

Bogotá, , Colombia

Site Status

S308.3.007 Site # 154

Bogotá, , Colombia

Site Status

S308.3.007 Site # 150

Medellín, , Colombia

Site Status

S308.3.007 Site # 160

Riga, , Latvia

Site Status

S308.3.007 Site # 172

Kaunas, , Lithuania

Site Status

S308.3.007 Site # 170

Vilnius, , Lithuania

Site Status

S308.3.007 Site # 171

Vilnius, , Lithuania

Site Status

S308.3.007 Site # 184

Bellavista Callao, , Peru

Site Status

S308.3.007 Site # 180

Lima, , Peru

Site Status

S308.3.007 Site # 181

Lima, , Peru

Site Status

S308.3.007 Site # 182

Lima, , Peru

Site Status

S308.3.007 Site # 183

Lima, , Peru

Site Status

S308.3.007 Site # 193

Kazan', , Russia

Site Status

S308.3.007 Site # 190

Moscow, , Russia

Site Status

S308.3.007 Site # 194

Moscow, , Russia

Site Status

S308.3.007 Site # 197

Moscow, , Russia

Site Status

S308.3.007 Site # 191

Saint Petersburg, , Russia

Site Status

S308.3.007 Site # 192

Saint Petersburg, , Russia

Site Status

S308.3.007 Site # 195

Saint Petersburg, , Russia

Site Status

S308.3.007 Site # 198

Saint Petersburg, , Russia

Site Status

S308.3.007 Site # 196

Yaroslavl, , Russia

Site Status

S308.3.007 Site # 204

Dnipro, , Ukraine

Site Status

S308.3.007 Site # 206

Kharkiv, , Ukraine

Site Status

S308.3.007 Site # 201

Kyiv, , Ukraine

Site Status

S308.3.007 Site # 202

Kyiv, , Ukraine

Site Status

S308.3.007 Site # 205

Lviv, , Ukraine

Site Status

S308.3.007 Site # 203

Poltava, , Ukraine

Site Status

S308.3.007 Site # 208

Simferopol, , Ukraine

Site Status

S308.3.007 Site # 200

Vinnytsia, , Ukraine

Site Status

S308.3.007 Site # 207

Zaporozhya, , Ukraine

Site Status

Countries

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United States Albania Argentina Brazil Bulgaria Canada Chile Colombia Latvia Lithuania Peru Russia Ukraine

Other Identifiers

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2006-005183-91

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

00407095

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S308.3.007

Identifier Type: -

Identifier Source: org_study_id