SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of SLV308 as Adjunct Therapy to Levodopa in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00406588

Enrollment

295

Registered

2006-12-04

Start date

2007-03-31

Completion date

2008-05-31

Last updated

2015-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Stage Parkinson's Disease

Keywords

Parkinson Disease

Brief summary

This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance 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.

Interventions

DRUGLevodopa (Pardoprunox)

12-42mg

DRUGPlacebo Comparator

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of idiopathic Parkinson's Disease, * advance stage of disease, * Modified Hoehn & Yahr stage II-IV, * presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization

Exclusion criteria

* 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration, * Prevalent expression of troublesome dyskinesias during 'on' time at waking hours, * Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, * Previous surgery for the treatment of PD

Design outcomes

Primary

Measure	Time frame
Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries.	12 weeks

Secondary

Measure	Time frame
Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39	12 weeks

Countries

Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, Latvia, Lithuania, Peru, Russia, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026