SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease

Phase 3

Completed

• Conditions: Early Stage Parkinson Disease
• Interventions: Drug: Pardaprunox; Drug: pramipexole; Drug: Placebo Comparator

• Registration Number: NCT00335166
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as 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

Not available

Study Timeline

• Study First Submitted: 2006-06-08
• Study First Submitted QC: 2006-06-08
• Study First Posted: 2006-06-09
• Study Start: 2006-11
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-01
• Last Update Posted: 2008-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Diagnosis of idiopathic Parkinson's Disease, Modified Hoehn & Yahr up to stage III, UPDRS motor score (part III) must have a total of at least 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,
• Current presence of dyskinesias,
• Motor fluctuations or loss of postural reflexes,
• A history of non-response to an adequate course of l-dopa or a dopamine agonist,
• Patients for whom previously treatment with dopamine agonists needed to terminate because of induction of psychosis (i.e. hallucinations) and /or sleep attacks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pardaprunox	-
2	pramipexole	-
3	Placebo Comparator	-

Primary Outcome Measures

Name	Time	Method
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment	24 weeks

Secondary Outcome Measures

Name	Time	Method
UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment.	24 weeks

Trial Locations

Locations (89)

418; 🇺🇸 Albany, New York, United States

336; 🇮🇳 Mumbai, India

371; 🇵🇱 Kalisz, Poland

420; 🇺🇸 Boston, Massachusetts, United States

405; 🇺🇸 Boston, Massachusetts, United States

315; 🇨🇿 Kralove, Czech Republic

388; 🇨🇳 Hualien, Taiwan

421; 🇺🇸 Augusta, Georgia, United States

412; 🇺🇸 Raleigh, North Carolina, United States

419; 🇺🇸 Birmingham, Alabama, United States

422; 🇺🇸 New Haven, Connecticut, United States

406; 🇺🇸 Minneapolis, Minnesota, United States

410; 🇺🇸 Ft Wayne, Indiana, United States

415; 🇺🇸 Grand Rapids, Michigan, United States

411; 🇺🇸 Sarasota, Florida, United States

413; 🇺🇸 Oceanside, California, United States

313; 🇨🇿 Olomouc, Czech Republic

311; 🇨🇿 Plzen, Czech Republic

320; 🇪🇪 Tallinn, Estonia

304; 🇦🇺 Cheltenham, Australia

314; 🇨🇿 Ostrava, Czech Republic

347; 🇮🇹 Arcugnano (VI), Italy

301; 🇦🇺 Concord, Australia

302; 🇦🇺 Westmead, Australia

310; 🇨🇿 Ostrava, Czech Republic

339; 🇮🇳 Hyderabad, India

340; 🇮🇳 Mumbai, India

348; 🇮🇹 Grosseto GR, Italy

326; 🇩🇪 Wiesbaden, Germany

343; 🇮🇹 Roma, Italy

312; 🇨🇿 Pardubice, Czech Republic

338; 🇮🇳 Bangalore, India

337; 🇮🇳 Kerala, India

361; 🇳🇱 Hertogenbosch, Netherlands

346; 🇮🇹 Lido di Camaiore (LU), Italy

325; 🇫🇷 Toulouse, France

329; 🇩🇪 Heidelberg, Germany

345; 🇮🇹 Roma, Italy

327; 🇩🇪 Homburg, Germany

331; 🇩🇪 Gottingen, Germany

328; 🇩🇪 Lubeck, Germany

428; 🇱🇹 Kaunas, Lithuania

429; 🇱🇹 Vilnius, Lithuania

356; 🇲🇾 Pulau Pinang, Malaysia

365; 🇵🇱 Krakow, Poland

367; 🇵🇱 Torun, Poland

376; 🇵🇹 Coimbra, Portugal

364; 🇳🇱 Eindhoven, Netherlands

380; 🇿🇦 Gauteng, South Africa

377; 🇿🇦 Cape Town, South Africa

427; 🇱🇹 Vilnius, Lithuania

355; 🇲🇾 Kelantan, Malaysia

357; 🇲🇾 Kuala Lumpur, Malaysia

373; 🇵🇱 Gdansk, Poland

369; 🇵🇱 Katowice, Poland

370; 🇵🇱 Mosina, Poland

375; 🇵🇹 Lisboa, Portugal

362; 🇳🇱 Groningen, Netherlands

360; 🇳🇱 RM Groningen, Netherlands

383; 🇪🇸 Barcelona, Spain

374; 🇵🇱 Katowice, Poland

368; 🇵🇱 Leszno, Poland

385; 🇨🇳 Taipei, Taiwan

366; 🇵🇱 Lublin, Poland

381; 🇿🇦 Pretoria, South Africa

382; 🇪🇸 San Sebastian, Spain

379; 🇿🇦 Sandton, South Africa

386; 🇨🇳 Kweishan, Taiwan

393; 🇹🇭 Bangkok, Thailand

394; 🇹🇭 Ubonratchathani Province, Thailand

387; 🇨🇳 Kaohsiung, Taiwan

391; 🇹🇭 Bangkok, Thailand

396; 🇬🇧 Blackpool, United Kingdom

332; 🇩🇪 Bochum, Germany

408; 🇺🇸 Oxnard, California, United States

417; 🇺🇸 Lexington, Kentucky, United States

416; 🇺🇸 Golden Valley, Minnesota, United States

321; 🇪🇪 Tartu, Estonia

323; 🇫🇷 Aix en Provence, France

363; 🇳🇱 Emmen, Netherlands

344; 🇮🇹 Pescara, Italy

389; 🇨🇳 Kaohsiung Hsien, Taiwan

384; 🇪🇸 Colmenar Viejo, Spain

403; 🇺🇸 Boca Raton, Florida, United States

303; 🇦🇺 Bedford Park, Australia

324; 🇫🇷 Toulon, France

424; 🇺🇸 Charlotte, North Carolina, United States

330; 🇩🇪 Leipzig, Germany

378; 🇿🇦 Cape Town, South Africa