Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243971
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2005-10-24
Brief Title:
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 Parkinsons Disease
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
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 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 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
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
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 |
|---|---|---|---|
| 2004-002609-66 | EUDRACT_NUMBER | None | None |