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Completed

NCT Number: NCT00269516

SLV308 for Treatment of Patients With Early Parkinson's Disease

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

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Key information

Conditions

Early Stage Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 201, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of idiopathic Parkinson's Disease,
  • Early stage of disease, Modified Hoehn & Yahr up to stage III,
  • UPDRS motor score (part III) 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,
  • Presence of dyskinesias,
  • Motor fluctuations or loss of postural reflexes,
  • Clinically significant abnormalities,
  • Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
  • Antipsychotic.

Treatment and study plan

Pardoprunox

Drug

fixed dose 6 mg

Placebo

Drug

Placebo

Primary outcomes

  1. UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 23, 2005
Registry last updated
Aug 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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