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Trial record 1 of 2 for:    NCT00244387
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Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa

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ClinicalTrials.gov Identifier: NCT00244387
Recruitment Status : Completed
First Posted : October 26, 2005
Last Update Posted : September 25, 2014
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:

Male and female patients aged ≥ 30 years with advanced stage idiopathic Parkinson's disease, not well controlled on existing levodopa will take part in a research study at approximately 82 sites in Europe, Israel, South Africa, Australia and new Zealand.

The purpose of the study is to evaluate the effectiveness, safety and tolerability of the rotigotine patch (SPM 962) at an individual patient's optimal dose for a period of 4 months

Each patient who qualifies and chooses to participate in the study will receive either rotigotine, pramipexole, or placebo at gradually increasing doses over a period of up to 7 weeks, and then maintain their optimal dose for 4 months.

The study clinic visits will include a medical history and physical exam, ECG, blood and urine sample collection, completion of various questionnaires, and completion of a diary to record the severity of their Parkinson's symptoms.

Patients who complete the study may enroll in an extension trial and receive active study drug.


Condition or disease Intervention/treatment Phase
Parkinson Disease, Idiopathic Drug: SPM 962 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-centre, Multi-national, Phase 3, Randomized, Double-blind, Double-dummy, 3- Arm Parallel Group, Placebo- and Pramipexole- Controlled Trial of the Efficacy and Safety of Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa
Study Start Date : March 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

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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
Criteria

Inclusion Criteria:

  • Advanced stage idiopathic Parkinson's disease

Exclusion Criteria:

  • Well controlled on levodopa

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): NCT00244387


Locations
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Germany
Schwarz
Monheim, Germany
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00244387    
Other Study ID Numbers: SP0515
First Posted: October 26, 2005    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: February 2010
Keywords provided by UCB Pharma:
advanced stage idiopathic Parkinson's 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
Levodopa
Rotigotine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists