SLV308 for Treatment of Patients With Early Parkinson's Disease

NCT ID: NCT00269516

Last Updated: 2008-08-29

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

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-12-31

Brief Summary

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This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

Detailed Description

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Conditions

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Early Stage Parkinson's Disease

Keywords

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Parkinson's disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

pardoprunox

Intervention Type DRUG

fixed dose 6 mg

2

Group Type EXPERIMENTAL

Pardoprunox

Intervention Type DRUG

fixed dose 12 mg

3

Group Type EXPERIMENTAL

Pardoprunox

Intervention Type DRUG

12-42mg

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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pardoprunox

fixed dose 6 mg

Intervention Type DRUG

Pardoprunox

fixed dose 12 mg

Intervention Type DRUG

Pardoprunox

12-42mg

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of idiopathic Parkinson's Disease,
* Early stage of disease, Modified Hoehn \& Yahr up to stage III,
* UPDRS motor score (part III) 10 at baseline.

Exclusion Criteria

* Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
* Patients who have undergone surgery for the treatment of PD,
* Presence of dyskinesias,
* Motor fluctuations or loss of postural reflexes,
* Clinically significant abnormalities,
* Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
* Antipsychotic.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Solvay Pharmaceuticals

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 284

Huntsville, Alabama, United States

Site Status

Site 274

Little Rock, Arkansas, United States

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Site 283

Fountain Valley, California, United States

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Site 277

La Jolla, California, United States

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Site 271

San Francisco, California, United States

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Site 279

Fort Lauderdale, Florida, United States

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Site 293

Gainsville, Florida, United States

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Site 282

Port Charlotte, Florida, United States

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Site 285

Sunrise, Florida, United States

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Site 273

Tampa, Florida, United States

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Site 290

Chicago, Illinois, United States

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Site 280

Kansas City, Kansas, United States

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Site 292

Bingham Farms, Michigan, United States

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Site 275

Traverse City, Michigan, United States

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Site 276

St Louis, Missouri, United States

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Site 287

St Louis, Missouri, United States

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Site 278

Las Vegas, Nevada, United States

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Site 286

Rochester, New York, United States

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Site 288

Ashville, North Carolina, United States

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Site 289

Charlotte, North Carolina, United States

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Site 294

Toledo, Ohio, United States

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Site 281

Pittsburgh, Pennsylvania, United States

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Site 291

Warwick, Rhode Island, United States

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Site 272

Houston, Texas, United States

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Site 201

Buenos Aires, , Argentina

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Site 202

Buenos Aires, , Argentina

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Site 203

Buenos Aires, , Argentina

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Site 204

Buenos Aires, , Argentina

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Site 206

Buenos Aires, , Argentina

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Site 208

Capital Federal, CBA, , Argentina

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Site 207

Ciudad de Buenos Aires, , Argentina

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Site 205

Córdoba, , Argentina

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Site 100

Brussels, , Belgium

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Site 101

Genk, , Belgium

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Site 102

Wilrijk, , Belgium

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Site 107

Plovdiv, , Bulgaria

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Site 103

Sofia, , Bulgaria

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Site 104

Sofia, , Bulgaria

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Site 105

Sofia, , Bulgaria

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Site 106

Sofia, , Bulgaria

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Site 268

Barrie, , Canada

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Site 260

Calgary, , Canada

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Site 264

Greenfield Park, , Canada

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Site 263

Markham, , Canada

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Site 261

Ottawa, , Canada

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Site 266

Ottawa, , Canada

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Site 262

Québec, , Canada

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Site 265

Québec, , Canada

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Site 269

Saskatoon, , Canada

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Site 267

Toronto, , Canada

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Site 213

Providencia, , Chile

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Site 211

San Miguel, , Chile

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Santiago, , Chile

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Valdivia, , Chile

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Site 221

Bogotá, , Colombia

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Site 223

Bogotá, , Colombia

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Bogotá, , Colombia

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Cali, , Colombia

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Medellín, , Colombia

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Site 111

Rijeka, , Croatia

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Site 112

Split, , Croatia

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Site 110

Zagreb, , Croatia

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Site 113

Zagreb, , Croatia

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Site 114

Zagreb, , Croatia

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Site 123

Kuopio, , Finland

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Lappeenranta, , Finland

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Oulun Yliopisto, , Finland

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Tampere, , Finland

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Site 124

Turku, , Finland

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Site 196

Bangalore, , India

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Site 194

Hyderabaad, , India

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Mumbai, , India

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Mumbai, , India

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New Delhi, , India

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Thiruvananthapuram, , India

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Site 197

Visakhapatnam, , India

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Site 131

Haifa, , Israel

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Petah Tikva, , Israel

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Ramat Gan, , Israel

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Site 130

Tel Aviv, , Israel

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Site 232

Aguascalientes, , Mexico

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Site 230

Guadalajara - Jalisco, , Mexico

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Monterrey N.L., , Mexico

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Site 233

Tlalpan, , Mexico

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Site 191

Christchurch, , New Zealand

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Site 190

Wellington South, , New Zealand

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Site 244

Barrios Altos-Lima, , Peru

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Site 241

La Victoria-Lima, , Peru

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Lima, , Peru

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San Isidro-Lima, , Peru

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Site 242

Surco-Lima, , Peru

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Site 143

Brasov, , Romania

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Site 140

Bucharest, , Romania

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Site 141

Craiova, , Romania

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Site 142

Mures, , Romania

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Site 158

Kazan', , Russia

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Site 150

Moscow, , Russia

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Site 151

Moscow, , Russia

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Site 154

Moscow, , Russia

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Site 156

Moscow, , Russia

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Site 152

Saint Petersburg, , Russia

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Site 157

Saint Petersburg, , Russia

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Site 159

Saint Petersburg, , Russia

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Site 155

Smolensk, , Russia

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Site 153

Yaroslav, , Russia

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Site 160

Belgrade, , Serbia

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Site 161

Belgrade, , Serbia

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Site 162

Belgrade, , Serbia

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Site 163

Niš, , Serbia

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Site 170

Bratislava, , Slovakia

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Site 171

Bratislava, , Slovakia

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Site 174

Levice, , Slovakia

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Site 173

Nitra, , Slovakia

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Site 172

Žilina, , Slovakia

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Site 250

Cape Town, , South Africa

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Site 252

Cape Town, , South Africa

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Site 251

Durban, , South Africa

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Site 253

Gauteng, , South Africa

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Site 254

Pretoria, , South Africa

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Site 127

Gothenburg, , Sweden

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Site 126

Norrköping, , Sweden

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Site 125

Stockholm, , Sweden

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Site 180

Kharkiv, , Ukraine

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Site 183

Kharkiv, , Ukraine

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Site 181

Kyiv, , Ukraine

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Site 182

Kyiv, , Ukraine

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Site 185

Lviv, , Ukraine

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Site 184

Vinnytsia, , Ukraine

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Countries

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Serbia and Montenegro United States Argentina Belgium Bulgaria Canada Chile Colombia Croatia Finland India Israel Mexico New Zealand Peru Romania Russia Serbia Slovakia South Africa Sweden Ukraine

References

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Sampaio C, Bronzova J, Hauser RA, Lang AE, Rascol O, van de Witte SV, Theeuwes AA; Rembrandt/Vermeer Study Groups. Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials. Mov Disord. 2011 Jul;26(8):1464-76. doi: 10.1002/mds.23590. Epub 2011 May 3.

Reference Type DERIVED
PMID: 21542016 (View on PubMed)

Other Identifiers

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S308.3.001

Identifier Type: -

Identifier Source: org_study_id