At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 44 enrolled
Drug / intervention
Rotigotine Nasal Spray +1 moredrug
Likely dose
Rotigotine Nasal Spray 62µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Rotigotine Nasal Spray and Placebo Nasal Spray for Restless Legs Syndrome. Completed, enrolled 44 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome
CountriesGermany
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
First PostedOct 2006
Primary CompletionNov 2006
Study CompletionDec 2006
TodayJul 2026
First PostedOct 19, 2006
Enrollment StartAug 1, 2006
Primary CompletionNov 1, 2006
Study CompletionDec 1, 2006
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 19.7 years ago
Interventions
Rotigotine Nasal Spraydrug
Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution
Placebo Nasal Sprayother
Daily single dose of placebo delivered as single puff of nasal spray solution