Rotigotine
Treatment for Restless Legs Syndrome
Typical Dosage: 1-3 mg/24 hours patch daily
Effectiveness
77%
Safety Score
57%
Clinical Trials
23
Participants
2K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
57
DangerousModerateSafe
Treatment Details
Dosage Range
1-3 mg/24 hours patch daily
Time to Effect
1-3 days
Treatment Duration
lifetime
Evidence Quality
HIGHNumber Needed to Treat (NNT)
5(Treat 5 patients to see 1 additional successful outcome)
Confidence Score
88%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$9,000
Monitoring:$300
Side Effect Mgmt:$100
Total Annual:$9,400
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
MODERATEICER
$100,000/QALY
QALYs Gained
0.2
Outcome-Based Costs
Cost per Responder
$13,926
Cost per Remission
$41,778
Comparison vs Pramipexole
Cost Difference
+$8,870/year
More expensive
QALY Difference
0.00 QALYs
Same outcomes
Dominance
No dominance
Rotigotine Outcomes
for Restless Legs Syndrome
Efficacy Outcomes
Overall Effectiveness
+77%
Response Rate
+68%
Remission Rate
+22%
Common Side Effects
Application site reactions
+15%
Nausea
+15%
Somnolence
+12%
Augmentation (long-term)
+30%
Sources:
Active Clinical Trials
No active trials currently recruiting for this treatment
No active trials found in ClinicalTrials.gov
Completed Clinical Trials
18 completed trials for Rotigotine in Restless Legs Syndrome
Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome
NCT01495793COMPLETEDPHASE2
42 participants
INTERVENTIONAL
Little Rock, United States +11 more
Started: Dec 1, 2011
Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
NCT00498186COMPLETEDPHASE2
295 participants
INTERVENTIONAL
Innsbruck, Austria +23 more
Started: Jul 1, 2003
Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome
NCT01498120COMPLETEDPHASE2
14 participants
INTERVENTIONAL
Los Angeles, United States +4 more
Started: Dec 1, 2011
Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS)
NCT01569464COMPLETEDPHASE3
150 participants
INTERVENTIONAL
Birmingham, United States +17 more
Started: Mar 1, 2012
An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome
NCT00263068COMPLETEDPHASE3
279 participants
INTERVENTIONAL
RTP, United States
Started: Dec 1, 2005
Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
NCT00135993COMPLETEDPHASE3
811 participants
INTERVENTIONAL
RTP, United States
Started: May 1, 2005
A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
NCT00275236COMPLETEDPHASE3
60 participants
INTERVENTIONAL
Monheim, Germany
Started: Nov 1, 2005
Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome
NCT01455012COMPLETEDPHASE4
81 participants
INTERVENTIONAL
Berlin, Germany +5 more
Started: Sep 1, 2011
Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome
NCT00136045COMPLETEDPHASE3
549 participants
INTERVENTIONAL
Monheim, Germany
Started: May 1, 2005
Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise
NCT01113710COMPLETED
687 participants
OBSERVATIONAL
Abensburg, Germany +79 more
Started: May 1, 2010
Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects
NCT00498108COMPLETEDPHASE3
341 participants
INTERVENTIONAL
Kassel, Germany
Started: Jan 1, 2006
Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome
NCT01823770COMPLETEDPHASE4
130 participants
INTERVENTIONAL
Montpellier, France
Started: Nov 26, 2012
Switching From Oral Dopamine Agonists to Rotigotine
NCT01976871COMPLETEDPHASE4
21 participants
INTERVENTIONAL
Boston, United States
Started: Aug 1, 2014
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms
NCT00389831COMPLETEDPHASE2
44 participants
INTERVENTIONAL
Monheim, Germany
Started: Aug 1, 2006
A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
NCT01562743COMPLETEDPHASE2
185 participants
INTERVENTIONAL
Started: Aug 1, 2008
A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
NCT00666965COMPLETEDPHASE2
230 participants
INTERVENTIONAL
Chubu Region, Japan +7 more
Started: Jun 1, 2008
A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis
NCT01537042COMPLETEDPHASE3
30 participants
INTERVENTIONAL
Brandon, United States +14 more
Started: Apr 1, 2012
Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation
NCT01386944COMPLETED
102 participants
OBSERVATIONAL
Berlin, Germany +17 more
Started: Jul 1, 2011
Showing 20 of 23 total trials