Last reviewed · How we verify
NCT00335166
A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease.
Phase 3 trial testing Pardaprunox in Early Stage Parkinson Disease in 330 participants. Completed in 1 February 2008.
1 February 2008
Quick facts
| Lead sponsor | Solvay Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 330 |
| Start date | 1 November 2006 |
| Primary completion | 1 February 2008 |
| Estimated completion | 1 February 2008 |
| Sites | 89 locations across United States, Australia, Czechia, Estonia, France, Germany, India, Italy |
Drugs / interventions tested
- Pardaprunox — full drug profile →
- pramipexole — full drug profile →
- Placebo Comparator
Conditions studied
- Early Stage Parkinson Disease — all drugs for Early Stage Parkinson Disease →
Sponsor
Solvay Pharmaceuticals — full company profile →
Who can join
30 and older, any sex, with Early Stage Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
Time frame: 24 weeks
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2
Verify or expand the search:
- PubMed search for NCT00335166
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00335166 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Solvay Pharmaceuticals
- Last refreshed: 1 April 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00335166.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing