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| Sponsor: | UCB, Inc. |
|---|---|
| Information provided by: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00242008 |
Purpose
The purpose of this trial is to assess whether it is possible for subjects with idiopathic Parkinson's Disease to switch from ropinirole, pramipexole and cabergoline to rotigotine transdermal system (SPM 962) overnight without worsening of Parkinson's Disease symptoms.
Subjects who meet eligibility criteria will be switched overnight to treatment with rotigotine transdermal patches at a dose considered equivalent to the dose of dopamine agonist that the subject is currently taking. Subjects on ropinirole or pramipexole will take their last dose at bedtime and then apply rotigotine patch(es) upon awakening the next morning. Subjects on cabergoline will apply rotigotine patches 24 hours after the final dose of cabergoline. Subjects will continue rotigotine treatment for 28 days, during which dose can be increased or decreased as needed. At the end of treatment, subjects can select to enroll in an open-label extension trial.
The first subject was enrolled on 28 December 2004. The last subject was enrolled in June 2005 and the last subject visit was conducted in July 2005. This study is now closed.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: Rotigotine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3b, Open-Label, Multicenter, Multinational Trial To Assess The Tolerability Of Switching Subjects From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System And Its Effect On Symptoms In Subjects With Idiopathic Parkinson's Disease |
| Study Start Date: | December 2004 |
| Study Completion Date: | July 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00242008 History of Changes |
| Other Study ID Numbers: | SP824 |
| Study First Received: | October 18, 2005 |
| Last Updated: | September 9, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
IDIOPATHIC PARKINSON'S DISEASE |
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Pramipexol Cabergoline Ropinirole N 0437 Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents Antineoplastic Agents |
