NCT00335374

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_3

Geographic Reach
15 countries

75 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

First Submitted

Initial submission to the registry

June 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2006

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

1.1 years

First QC Date

June 8, 2006

Last Update Submit

February 5, 2009

Conditions

Early Stage Parkinson's Disease

Keywords

Parkinson's disease

Outcome Measures

Primary Outcomes (1)

  • Safety: laboratory data, adverse events, vital signs, ECG

    24 weeks

Secondary Outcomes (1)

  • UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline

    24 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: Pardoprunox

Interventions

PardoprunoxDRUG

12 -42 mg

1

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have completed S308.3.003 trial

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (75)

419

Birmingham, Alabama, United States

Location

413

Oceanside, California, United States

Location

408

Oxnard, California, United States

Location

422

New Haven, Connecticut, United States

Location

403

Boca Raton, Florida, United States

Location

411

Sarasota, Florida, United States

Location

421

Augusta, Georgia, United States

Location

410

Fort Wayne, Indiana, United States

Location

417

Lexington, Kentucky, United States

Location

405

Boston, Massachusetts, United States

Location

420

Boston, Massachusetts, United States

Location

406

Minneapolis, Minnesota, United States

Location

412

Raleigh, North Carolina, United States

Location

Site 402

Dayton, Ohio, United States

Location

303

Bedford Park, Australia

Location

304

Cheltenham, Australia

Location

301

Concord, Australia

Location

Site 300

East Gosford, Australia

Location

302

Westmead, Australia

Location

315

Kralove, Czechia

Location

313

Olomouc, Czechia

Location

310

Ostrava, Czechia

Location

314

Ostrava, Czechia

Location

312

Pardubice, Czechia

Location

311

Pilsen, Czechia

Location

320

Tallinn, Estonia

Location

321

Tartu, Estonia

Location

332

Bochum, Germany

Location

331

Göttingen, Germany

Location

329

Heidelberg, Germany

Location

330

Leipzig, Germany

Location

328

Lübeck, Germany

Location

326

Wiesbaden, Germany

Location

338

Bangalore, India

Location

339

Hyderabaad, India

Location

337

Kerala, India

Location

336

Mumbai, India

Location

340

Mumbai, India

Location

348

Grosseto, Italy

Location

346

Lido di Camaiore, Italy

Location

344

Pescara, Italy

Location

343

Roma, Italy

Location

345

Roma, Italy

Location

428

Kaunas, Lithuania

Location

427

Vilnius, Lithuania

Location

429

Vilnius, Lithuania

Location

355

Kelantan, Malaysia

Location

357

Kuala Lumpur, Malaysia

Location

356

Pulau Pinang, Malaysia

Location

361

's-Hertogenbosch, Netherlands

Location

364

Eindhoven, Netherlands

Location

360

Groningen, Netherlands

Location

362

Groningen, Netherlands

Location

373

Gdansk, Poland

Location

371

Kalisz, Poland

Location

369

Katowice, Poland

Location

365

Krakow, Poland

Location

368

Leszno, Poland

Location

366

Lublin, Poland

Location

370

Mosina, Poland

Location

376

Coimbra, Portugal

Location

375

Lisbon, Portugal

Location

377

Cape Town, South Africa

Location

378

Cape Town, South Africa

Location

380

Gauteng, South Africa

Location

381

Pretoria, South Africa

Location

379

Sandton, South Africa

Location

388

Hualien City, Taiwan

Location

387

Kaohsiung City, Taiwan

Location

389

Kaohsiung Hsien, Taiwan

Location

386

Kwei-Shan, Taiwan

Location

385

Taipei, Taiwan

Location

391

Bangkok, Thailand

Location

393

Bangkok, Thailand

Location

394

Ubonratchathani, Thailand

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

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    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

June 8, 2006

First Posted

June 9, 2006

Study Start

August 1, 2007

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

ES(2)TH(3)TW(5)MY(3)US(14)IN(5)PL(7)ZA(5)CZ(6)NL(4)LI(3)DE(6)AU(5)PT(2)IT(5)