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An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00407095
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : September 13, 2010
Sponsor:
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
This study is a multicenter, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.002 study.

Condition or disease Intervention/treatment Phase
Advanced Stage Parkinson's Disease Drug: Pardoprunox Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
Study Start Date : August 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: Pardoprunox
12-42 mg/day




Primary Outcome Measures :
  1. Safety: laboratory data, adverse events, vital signs, ECG [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline [ Time Frame: 36 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria Patients who have completed S308.3.002 trial Exclusion Criteria Patients with medically relevant abnormal findings (ECG, physical examination, Aes) at end of the maintenance phase (visit M6, week 24) of study S308.3.002

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407095


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Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
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Study Director: Erik Vanleeuwen Abbott Products

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ClinicalTrials.gov Identifier: NCT00407095     History of Changes
Other Study ID Numbers: S308.3.007
2006-005183-91 ( EudraCT Number )
00407095 ( Other Grant/Funding Number: NCT/NIH )
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: September 2010
Keywords provided by Solvay Pharmaceuticals:
Parkinson Disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases