An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients

NCT ID: NCT00335374

Last Updated: 2009-02-06

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

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-11-30

Brief Summary

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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 S308.3.003 trial

Detailed Description

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Conditions

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Early 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

Interventions

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Pardoprunox

12 -42 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have completed S308.3.003 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 S308.3.003
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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419

Birmingham, Alabama, United States

Site Status

413

Oceanside, California, United States

Site Status

408

Oxnard, California, United States

Site Status

422

New Haven, Connecticut, United States

Site Status

403

Boca Raton, Florida, United States

Site Status

411

Sarasota, Florida, United States

Site Status

421

Augusta, Georgia, United States

Site Status

410

Fort Wayne, Indiana, United States

Site Status

417

Lexington, Kentucky, United States

Site Status

405

Boston, Massachusetts, United States

Site Status

420

Boston, Massachusetts, United States

Site Status

406

Minneapolis, Minnesota, United States

Site Status

412

Raleigh, North Carolina, United States

Site Status

Site 402

Dayton, Ohio, United States

Site Status

303

Bedford Park, , Australia

Site Status

304

Cheltenham, , Australia

Site Status

301

Concord, , Australia

Site Status

Site 300

East Gosford, , Australia

Site Status

302

Westmead, , Australia

Site Status

315

Kralove, , Czechia

Site Status

313

Olomouc, , Czechia

Site Status

310

Ostrava, , Czechia

Site Status

314

Ostrava, , Czechia

Site Status

312

Pardubice, , Czechia

Site Status

311

Pilsen, , Czechia

Site Status

320

Tallinn, , Estonia

Site Status

321

Tartu, , Estonia

Site Status

332

Bochum, , Germany

Site Status

331

Göttingen, , Germany

Site Status

329

Heidelberg, , Germany

Site Status

330

Leipzig, , Germany

Site Status

328

Lübeck, , Germany

Site Status

326

Wiesbaden, , Germany

Site Status

338

Bangalore, , India

Site Status

339

Hyderabaad, , India

Site Status

337

Kerala, , India

Site Status

336

Mumbai, , India

Site Status

340

Mumbai, , India

Site Status

348

Grosseto, , Italy

Site Status

346

Lido di Camaiore, , Italy

Site Status

344

Pescara, , Italy

Site Status

343

Roma, , Italy

Site Status

345

Roma, , Italy

Site Status

428

Kaunas, , Lithuania

Site Status

427

Vilnius, , Lithuania

Site Status

429

Vilnius, , Lithuania

Site Status

355

Kelantan, , Malaysia

Site Status

357

Kuala Lumpur, , Malaysia

Site Status

356

Pulau Pinang, , Malaysia

Site Status

361

's-Hertogenbosch, , Netherlands

Site Status

364

Eindhoven, , Netherlands

Site Status

360

Groningen, , Netherlands

Site Status

362

Groningen, , Netherlands

Site Status

373

Gdansk, , Poland

Site Status

371

Kalisz, , Poland

Site Status

369

Katowice, , Poland

Site Status

365

Krakow, , Poland

Site Status

368

Leszno, , Poland

Site Status

366

Lublin, , Poland

Site Status

370

Mosina, , Poland

Site Status

376

Coimbra, , Portugal

Site Status

375

Lisbon, , Portugal

Site Status

377

Cape Town, , South Africa

Site Status

378

Cape Town, , South Africa

Site Status

380

Gauteng, , South Africa

Site Status

381

Pretoria, , South Africa

Site Status

379

Sandton, , South Africa

Site Status

388

Hualien City, , Taiwan

Site Status

387

Kaohsiung City, , Taiwan

Site Status

389

Kaohsiung Hsien, , Taiwan

Site Status

386

Kwei-Shan, , Taiwan

Site Status

385

Taipei, , Taiwan

Site Status

391

Bangkok, , Thailand

Site Status

393

Bangkok, , Thailand

Site Status

394

Ubonratchathani, , Thailand

Site Status

Countries

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United States Australia Czechia Estonia Germany India Italy Lithuania Malaysia Netherlands Poland Portugal South Africa Taiwan Thailand

Other Identifiers

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2006-000859-18

Identifier Type: -

Identifier Source: secondary_id

S308.3.008

Identifier Type: -

Identifier Source: org_study_id

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