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Completed

NCT Number: NCT00406588

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

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.

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Key information

Conditions

Advanced 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 100, 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,
  • 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

Treatment and study plan

Levodopa (Pardoprunox)

Drug

12-42mg

placebo comparator

Drug

Placebo

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study title

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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 4, 2006
Registry last updated
Feb 27, 2015

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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