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Sponsored by: |
UCB |
---|---|
Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00243945 |
The objective of this trial is to assess the effect of rotigotine (SPM 962) on the control of early morning motor impairment and sleep disorders in subjects with idiopathic PD. Subjects who meet eligibility criteria will begin treatment with rotigotine transdermal patches. Trial medication will be titrated to an optimal daily dose, or to the maximal dose. Following a Titration period of up to 8 weeks, subjects will be maintained on the optimal or maximal dose for 4 weeks.
After the Maintenance period, subjects will have the option to enter into an open-label extension study.
The first subject was enrolled in December 2004. The last subject was enrolled in April 2005 and the last subject visit was conducted in July 2005. This study is now closed
Condition | Intervention | Phase |
---|---|---|
Idiopathic Parkinson's Disease |
Drug: Rotigotine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Phase 3b, Open-Label, Multicenter, Multinational Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders in Patients With Idiopathic Parkinson's Disease |
Enrollment: | 58 |
Study Start Date: | December 2004 |
Study Completion Date: | July 2005 |
Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SP826 |
Study First Received: | October 24, 2005 |
Last Updated: | March 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00243945 History of Changes |
Health Authority: | United Kingdom: National Health Service |
Neurotransmitter Agents Ganglion Cysts Basal Ganglia Diseases Sleep Disorders Central Nervous System Diseases Dopamine Agonists Brain Diseases Neurodegenerative Diseases Signs and Symptoms |
Dopamine Parkinson Disease Movement Disorders Mental Disorders Neurologic Manifestations Dopamine Agents Parkinsonian Disorders N 0437 |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Sleep Disorders Central Nervous System Diseases Dopamine Agonists Brain Diseases Neurodegenerative Diseases |
Pharmacologic Actions Signs and Symptoms Parkinson Disease Movement Disorders Mental Disorders Neurologic Manifestations Dopamine Agents Parkinsonian Disorders N 0437 |