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Completed

NCT Number: NCT00335166

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

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.

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Key information

Conditions

Early Stage Parkinson 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

303, Bedford Park, Australia

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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, 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.

Treatment and study plan

Pardaprunox

Drug

12-42 mg

Pramipexole

Drug

1.5-4.5 mg

placebo comparator

Drug

Placebo

Primary outcomes

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

    Time frame: 24 weeks

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: 24 weeks

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study title

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.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 9, 2006
Registry last updated
Apr 3, 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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