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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00335166

Enrollment

330

Registered

2006-06-09

Start date

2006-11-30

Completion date

2008-02-29

Last updated

2008-04-03

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

Conditions

Early Stage Parkinson Disease

Keywords

Parkinson Disease

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.

Interventions

DRUGPardaprunox

12-42 mg

DRUGpramipexole

1.5-4.5 mg

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, 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.

Design outcomes

Primary

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

Secondary

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

Countries

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

Outcome results

None listed

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