A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: SPM 962 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Norbert Dank, Study Director, Affiliation: Schwarz
Summary
The objective of this trial is to compare the effect of rotigotine (SPM 962) and ropinirole
on the control of early morning motor impairment and sleep disorders in subjects with
early-stage PD.
Subjects who meet eligibility criteria will be randomly assigned either to rotigotine
transdermal patch or ropinirole tablets. Trial medication will be titrated for rotigotine and
ropinirole until an individual optimal dose is achieved. Following a Titration period of up
to 4 weeks in the rotigotine arm and 6 weeks in the ropinirole arm, subjects will be
maintained on the optimal or maximal dose for 4 weeks. At the end of the Maintenance period,
subjects will be given the opportunity to enter a 2-year rotigotine patch extension trial.
The first subject was enrolled in December 2004. The last subject was enrolled in June 2005.
Last subject out is expected for October 2005. The trial is still ongoing.
Clinical Details
Official title: A Phase 3, Randomized, Open-Label, Two-Arm, Parallel-Group, Multicenter, Multinational Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Early-stage, idiopathic Parkinson's disease
Locations and Contacts
Schwarz, Monheim, Germany
Additional Information
Starting date: November 2004
Ending date: October 2005
Last updated: March 7, 2008
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