Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242008
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2005-10-18
Brief Title:
A Trial To Assess Switching From Ropinirole Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinsons Disease
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
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 Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to assess whether it is possible for subjects with idiopathic Parkinsons Disease to switch from ropinirole pramipexole and cabergoline to rotigotine transdermal system SPM 962 overnight without worsening of Parkinsons 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 patches 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
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 patches 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-002650-59 | EUDRACT_NUMBER | None | None |