Pramipexole
Treatment for Restless Legs Syndrome
Typical Dosage: 0.125-0.5 mg daily
Effectiveness
80%
Safety Score
58%
Clinical Trials
30
Participants
5K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
58
DangerousModerateSafe
Treatment Details
Dosage Range
0.125-0.5 mg daily
Time to Effect
1-3 days
Treatment Duration
lifetime
Evidence Quality
HIGHNumber Needed to Treat (NNT)
4(Treat 4 patients to see 1 additional successful outcome)
Confidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$180
Monitoring:$300
Side Effect Mgmt:$50
Total Annual:$530
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
EXCELLENTICER
$10,000/QALY
QALYs Gained
0.2
Outcome-Based Costs
Cost per Responder
$757
Cost per Remission
$2,120
Pramipexole Outcomes
for Restless Legs Syndrome
Efficacy Outcomes
Overall Effectiveness
+80%
Response Rate
+70%
Remission Rate
+25%
Common Side Effects
Nausea
+15%
Somnolence
+15%
Dizziness
+10%
Augmentation (long-term)
+30%
Sources:
Active Clinical Trials
1 active trial recruiting for Pramipexole in Restless Legs Syndrome
Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy
NCT05003648ACTIVE NOT RECRUITINGPHASE4
24 participants
INTERVENTIONAL
Boston, United States +1 more
Started: Apr 1, 2023
Completed Clinical Trials
18 completed trials for Pramipexole in Restless Legs Syndrome
Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)
NCT02248142COMPLETED
1.03K participants
OBSERVATIONAL
Started: Feb 1, 2006
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
NCT02231918COMPLETEDPHASE2
26 participants
INTERVENTIONAL
Started: May 1, 2006
Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)
NCT02248155COMPLETED
2.64K participants
OBSERVATIONAL
Started: Apr 1, 2006
SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole
NCT00344994COMPLETEDPHASE4
20 participants
INTERVENTIONAL
Augusta, United States
Started: May 1, 2006
Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)
NCT00239486COMPLETEDPHASE2
109 participants
INTERVENTIONAL
Helsinki, Finland
Started: Oct 1, 2002
Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
NCT00721279COMPLETED
549 participants
OBSERVATIONAL
Absam, Austria +126 more
Started: Sep 1, 2007
Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome
NCT02025608COMPLETEDPHASE4
20 participants
INTERVENTIONAL
Lugano, Switzerland +1 more
Started: Dec 1, 2013
Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)
NCT00133198COMPLETEDPHASE3
345 participants
INTERVENTIONAL
Peoria, United States +43 more
Started: Apr 1, 2004
Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients
NCT00275457COMPLETEDPHASE3
346 participants
INTERVENTIONAL
Graz, Austria +33 more
Started: Oct 1, 2002
A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS
NCT00375284COMPLETEDPHASE4
404 participants
INTERVENTIONAL
Birmingham, United States +51 more
Started: Sep 1, 2006
Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
NCT00806026COMPLETEDPHASE3
731 participants
INTERVENTIONAL
Birmingham, United States +109 more
Started: Dec 1, 2008
Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)
NCT00654498COMPLETEDPHASE3
306 participants
INTERVENTIONAL
Beijing, China +15 more
Started: Apr 1, 2008
A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS
NCT00349531COMPLETEDPHASE4
369 participants
INTERVENTIONAL
Kongens Lyngby, Denmark +48 more
Started: Jul 1, 2006
A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)
NCT00152958COMPLETEDPHASE3
224 participants
INTERVENTIONAL
Berlin, Germany +11 more
Started: Jan 1, 2004
Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)
NCT00472199COMPLETEDPHASE4
331 participants
INTERVENTIONAL
Innsbruck, Austria +41 more
Started: May 1, 2007
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
NCT00991276COMPLETEDPHASE3
85 participants
INTERVENTIONAL
Jasper, United States +40 more
Started: Dec 1, 2009
Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances
NCT00356096COMPLETEDPHASE4
404 participants
INTERVENTIONAL
Espoo, Finland +53 more
Started: Jul 1, 2006
Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome
NCT00152997COMPLETEDPHASE2
41 participants
INTERVENTIONAL
Akita, Akita, Japan +6 more
Started: Aug 1, 2004
Showing 20 of 30 total trials