Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136045
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2005-08-24
Brief Title:
Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Multi-center Randomized Double-blind Placebo-controlled Four-arm Parallel-group Trial to Investigate the Efficacy and Safety of Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome
Status:
COMPLETED
Status Verified Date:
2010-02
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 primary objective of this trial is to demonstrate that rotigotine SPM 936 is efficacious in subjects with idiopathic restless leg syndrome RLS Additional objectives are to investigate the safety and tolerability of rotigotine
The primary variables are the absolute change from Baseline in the International Restless Legs Severity Scale IRLS sum score and Clinical Global Impression-Global Improvement CGI Item 1 severity of illness score at the end of the Maintenance Period
Subjects will be randomized to receive either placebo 225 45 or 675 mgday rotigotine in a 1111 activeplacebo fashion Approximately 450 subjects will be enrolled in this trial participating at approximately 50 sites The maximum duration of the trial is approximately 8 months 3-week Titration Period 6-month Maintenance Period 7-day Taper Period and 30-day Safety Follow-Up Period Subjects who complete the 6-month Maintenance Period will be eligible to participate in an open-label extension trial Subjects who do not complete the 6-month Maintenance Period or who choose not to participate in the open-label extension trial will complete a 3-day Safety Follow-Up Period Two different patch sizes will be used 5 and 10 cm2 Active patches will contain either 225mg 5cm2 or 45mg 10cm2 of rotigotine
The primary variables are the absolute change from Baseline in the International Restless Legs Severity Scale IRLS sum score and Clinical Global Impression-Global Improvement CGI Item 1 severity of illness score at the end of the Maintenance Period
Subjects will be randomized to receive either placebo 225 45 or 675 mgday rotigotine in a 1111 activeplacebo fashion Approximately 450 subjects will be enrolled in this trial participating at approximately 50 sites The maximum duration of the trial is approximately 8 months 3-week Titration Period 6-month Maintenance Period 7-day Taper Period and 30-day Safety Follow-Up Period Subjects who complete the 6-month Maintenance Period will be eligible to participate in an open-label extension trial Subjects who do not complete the 6-month Maintenance Period or who choose not to participate in the open-label extension trial will complete a 3-day Safety Follow-Up Period Two different patch sizes will be used 5 and 10 cm2 Active patches will contain either 225mg 5cm2 or 45mg 10cm2 of rotigotine
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 |
|---|---|---|---|
| 2005-000428-18 | EUDRACT_NUMBER | None | None |