Status:
COMPLETED
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms
Lead Sponsor:
UCB Pharma
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 30m...
Eligibility Criteria
Inclusion
- Subjects with idiopathic RLS, who are responding to an ongoing L-dopa treatment
Exclusion
- Patients with secondary RLS or clinically relevant concomitant diseases or medical conditions are excluded
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00389831
Start Date
August 1 2006
End Date
December 1 2006
Last Update
October 2 2014
Active Locations (1)
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1
Schwarz BioSciences GmbH
Monheim, Germany