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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

140

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Aug 2007

Geographic Reach

13 countries

87 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

November 30, 2006

Completed

4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed

8 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed

Last Updated

September 13, 2010

Status Verified

September 1, 2010

Enrollment Period

1.8 years

First QC Date

November 30, 2006

Last Update Submit

September 10, 2010

Conditions

Advanced Stage Parkinson's Disease

Keywords

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (1)

1

EXPERIMENTAL

Drug: Pardoprunox

Interventions

PardoprunoxDRUG

12-42 mg/day

Eligibility Criteria

Age30 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Solvay Pharmaceuticalslead

Study Sites (87)

S308.3.007 Site # 220

La Jolla, California, United States

Location

S308.3.007 Site # 211

San Francisco, California, United States

Location

S308.3.007 Site # 214

Fort Lauderdale, Florida, United States

Location

S308.3.007 Site # 218

Gainsville, Florida, United States

Location

S308.3.007 Site # 213

Tampa, Florida, United States

Location

S308.3.007 Site # 219

Augusta, Georgia, United States

Location

S308.3.007 Site # 221

Chicago, Illinois, United States

Location

S308.3.007 Site # 216

Kansas City, Kansas, United States

Location

S308.3.007 Site # 224

Lexington, Kentucky, United States

Location

S308.3.007 Site # 212

East Lansing, Michigan, United States

Location

S308.3.007 Site # 217

St Louis, Missouri, United States

Location

S308.3.007 Site # 222

Durham, North Carolina, United States

Location

S308.3.007 Site # 210

Tledo, Ohio, United States

Location

S308.3.007 Site # 215

Houston, Texas, United States

Location

S308.3.007 Site # 223

Birmingham, Albania

Location

S308.3.007 Site # 100

Buenos Aires, Argentina

Location

S308.3.007 Site # 101

Buenos Aires, Argentina

Location

S308.3.007 Site # 102

Buenos Aires, Argentina

Location

S308.3.007 Site # 103

Buenos Aires, Argentina

Location

S308.3.007 Site # 106

Buenos Aires, Argentina

Location

S308.3.007 Site # 107

Buenos Aires, Argentina

Location

S308.3.007 Site # 109

Buenos Aires, Argentina

Location

S308.3.007 Site # 105

Córdoba, Argentina

Location

S308.3.007 Site # 104

Mar del Plata, Argentina

Location

S308.3.007 Site # 108

Santa Fe, Argentina

Location

S308.3.007 Site # 114

Alto da Glória, Brazil

Location

S308.3.007 Site # 113

Belo Horizonte, Brazil

Location

S308.3.007 Site # 112

Campinas, Brazil

Location

S308.3.007 Site # 116

Marília, Brazil

Location

S308.3.007 Site # 111

Porto Alegre, Brazil

Location

S308.3.007 Site # 118

Porto Alegre, Brazil

Location

S308.3.007 Site # 117

Ribeirão Preto, Brazil

Location

S308.3.007 Site # 119

Salvador, Brazil

Location

S308.3.007 Site # 115

Sâo Paulo, Brazil

Location

S308.3.007 Site # 110

São Paulo, Brazil

Location

S308.3.007 Site # 125

São Paulo, Brazil

Location

S308.3.007 Site # 123

Plovdiv, Bulgaria

Location

S308.3.007 Site # 120

Sofia, Bulgaria

Location

S308.3.007 Site # 121

Sofia, Bulgaria

Location

S308.3.007 Site # 122

Sofia, Bulgaria

Location

S308.3.007 Site # 124

Sofia, Bulgaria

Location

S308.3.007 Site # 136

Calgary, Canada

Location

S308.3.007 Site # 137

Greenfield Park, Canada

Location

S308.3.007 Site # 133

Halifax, Canada

Location

S308.3.007 Site # 132

Markham, Canada

Location

S308.3.007 Site # 130

Montreal, Canada

Location

S308.3.007 Site # 134

Ottawa, Canada

Location

S308.3.007 Site # 138

Peterborough, Canada

Location

S308.3.007 Site # 135

Sainte-Anne, Canada

Location

S308.3.007 Site # 139

Toronto, Canada

Location

S308.3.007 Site # 131

Windsor, Canada

Location

S308.3.007 Site # 140

Santiago, Chile

Location

S308.3.007 Site # 141

Santiago, Chile

Location

S308.3.007 Site # 143

Santiago, Chile

Location

S308.3.007 Site # 142

Valdivia, Chile

Location

S308.3.007 Site # 151

Bogotá, Colombia

Location

S308.3.007 Site # 152

Bogotá, Colombia

Location

S308.3.007 Site # 153

Bogotá, Colombia

Location

S308.3.007 Site # 154

Bogotá, Colombia

Location

S308.3.007 Site # 150

Medellín, Colombia

Location

S308.3.007 Site # 160

Riga, Latvia

Location

S308.3.007 Site # 172

Kaunas, Lithuania

Location

S308.3.007 Site # 170

Vilnius, Lithuania

Location

S308.3.007 Site # 171

Vilnius, Lithuania

Location

S308.3.007 Site # 184

Bellavista Callao, Peru

Location

S308.3.007 Site # 180

Lima, Peru

Location

S308.3.007 Site # 181

Lima, Peru

Location

S308.3.007 Site # 182

Lima, Peru

Location

S308.3.007 Site # 183

Lima, Peru

Location

S308.3.007 Site # 193

Kazan', Russia

Location

S308.3.007 Site # 190

Moscow, Russia

Location

S308.3.007 Site # 194

Moscow, Russia

Location

S308.3.007 Site # 197

Moscow, Russia

Location

S308.3.007 Site # 191

Saint Petersburg, Russia

Location

S308.3.007 Site # 192

Saint Petersburg, Russia

Location

S308.3.007 Site # 195

Saint Petersburg, Russia

Location

S308.3.007 Site # 198

Saint Petersburg, Russia

Location

S308.3.007 Site # 196

Yaroslavl, Russia

Location

S308.3.007 Site # 204

Dnipro, Ukraine

Location

S308.3.007 Site # 206

Kharkiv, Ukraine

Location

S308.3.007 Site # 201

Kyiv, Ukraine

Location

S308.3.007 Site # 202

Kyiv, Ukraine

Location

S308.3.007 Site # 205

Lviv, Ukraine

Location

S308.3.007 Site # 203

Poltava, Ukraine

Location

S308.3.007 Site # 208

Simferopol, Ukraine

Location

S308.3.007 Site # 200

Vinnytsia, Ukraine

Location

S308.3.007 Site # 207

Zaporozhya, Ukraine

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

pardoprunox

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

Erik Vanleeuwen
Abbott Products
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

August 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

September 13, 2010

Record last verified: 2010-09

Locations

RU(9)CO(5)CL(4)AL(1)LI(3)CA(10)PE(5)US(14)LA(1)BR(11)UA(9)BU(5)AR(10)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (87)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations