Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389831
Status:
COMPLETED
Last Update Posted:
2014-10-02
First Post:
2006-10-17
Brief Title:
Efficacy Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel-group Proof-of-concept Trial to Assess the Efficacy Safety and Tolerability of Ascending Doses of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms in Subjects With Idiopathic Restless Legs Syndrome
Status:
COMPLETED
Status Verified Date:
2011-02
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 main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome
Detailed Description:
Each patient of the placebo and rotigotine group performed an Eligibility Assessment as well 4 treatment days at which subjects performed a repeated Suggested Immobilization Test SIT during a 30min pre-dose and a 4 hours post-dose period During these periods the severity of RLS symptoms in the legs was assessed by the subject using a numeric symptom severity scale
In addition the leg movements were measured by actigraphy to assess the Periodic Leg Movement Index during Wakefulness PLMWI PLM per hour Subjects applied a single dose of treatment on each treatment day placebo nasal spray or rotigotine nasal spray in 3 ascending doses
In addition the leg movements were measured by actigraphy to assess the Periodic Leg Movement Index during Wakefulness PLMWI PLM per hour Subjects applied a single dose of treatment on each treatment day placebo nasal spray or rotigotine nasal spray in 3 ascending doses
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 |
|---|---|---|---|
| 2006-001937-17 | EUDRACT_NUMBER | None | None |