NCT00134251

Brief Summary

This study is a multicenter, randomized, double-blind, placebo controlled, parallel group study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations. Patients (outpatients) will be randomized to one of three different treatment arms.

Trial Health

85
On Track

Trial Health Score

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

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

First QC Date

August 22, 2005

Last Update Submit

January 29, 2009

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseadjunctive to L-dopa therapyAdvanced stage Parkinson's disease

Interventions

SLV308DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients who have signed an informed consent; diagnosis of idiopathic PD.
  • Presence of recognizable "on" and "off" stages
  • Minimum hours of "off" time per day of 2.5 hours
  • Able to keep diaries.

You may not qualify if:

  • Unclear diagnosis or a suspicion of other parkinsonian syndromes
  • Have undergone surgical treatment for PD
  • History of non-response to L-dopa.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Site 16

Plovdiv, Bulgaria

Location

Site 11

Sofia, Bulgaria

Location

Site 12

Sofia, Bulgaria

Location

Site 13

Sofia, Bulgaria

Location

Site 14

Sofia, Bulgaria

Location

Site 15

Sofia, Bulgaria

Location

Site 21

Guardamangia, Malta

Location

Site 31

Belgrade, Serbia

Location

Site 34

Belgrade, Serbia

Location

Site 33

Niš, Serbia

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
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

October 1, 2005

Last Updated

January 30, 2009

Record last verified: 2009-01

Locations

BU(6)MA(1)SE(3)