Gabapentin Enacarbil
Treatment for Restless Legs Syndrome
Typical Dosage: 600-1200 mg once daily
Effectiveness
75%
Safety Score
62%
Clinical Trials
26
Participants
3K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
62
DangerousModerateSafe
Treatment Details
Dosage Range
600-1200 mg once daily
Time to Effect
1-2 weeks
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:$7,200
Monitoring:$300
Side Effect Mgmt:$50
Total Annual:$7,550
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POORICER
$180,000/QALY
QALYs Gained
0.25
Outcome-Based Costs
Cost per Responder
$11,103
Cost per Remission
$34,318
Comparison vs Pramipexole
Cost Difference
+$7,020/year
More expensive
QALY Difference
+0.05 QALYs
Better outcomes
Dominance
No dominance
Gabapentin Enacarbil Outcomes
for Restless Legs Syndrome
Efficacy Outcomes
Overall Effectiveness
+75%
Response Rate
+68%
Remission Rate
+22%
Common Side Effects
Somnolence
+25%
Dizziness
+20%
Nausea
+8%
Sources:
Active Clinical Trials
1 active trial recruiting for Gabapentin Enacarbil in Restless Legs Syndrome
Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
NCT03082755RECRUITINGPHASE4
156 participants
INTERVENTIONAL
Austin, United States
Started: Jul 1, 2017
Completed Clinical Trials
14 completed trials for Gabapentin Enacarbil in Restless Legs Syndrome
A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
NCT03053427COMPLETEDPHASE4
375 participants
INTERVENTIONAL
Nagoya, Japan +45 more
Started: Mar 30, 2017
Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment
NCT01981941COMPLETEDPHASE4
19 participants
INTERVENTIONAL
Chugoku, Japan +4 more
Started: Nov 5, 2013
The Effect of Horizant (Gabapentin Enacarbil) on Augmentation
NCT02642315COMPLETEDNA
10 participants
INTERVENTIONAL
Columbia, United States
Started: Jan 1, 2016
Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy Subjects
NCT01411124COMPLETEDPHASE1
36 participants
INTERVENTIONAL
Austin, United States
Started: Jun 1, 2011
Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
NCT02658188COMPLETEDPHASE3
182 participants
INTERVENTIONAL
Chiba, Japan +9 more
Started: Dec 1, 2007
Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study
NCT01668667COMPLETEDPHASE4
501 participants
INTERVENTIONAL
Phoenix, United States +41 more
Started: Jun 1, 2012
XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
NCT00365352COMPLETEDPHASE3
325 participants
INTERVENTIONAL
Started: Aug 1, 2006
XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.
NCT00333359COMPLETEDPHASE3
581 participants
INTERVENTIONAL
Started: Jun 1, 2006
Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
NCT00748098COMPLETEDPHASE3
136 participants
INTERVENTIONAL
Jasper, United States +23 more
Started: Oct 1, 2008
Specified Drug Use-Results Survey of Regnite
NCT01887613COMPLETED
1.6K participants
OBSERVATIONAL
Chūbu, Japan +6 more
Started: Oct 1, 2012
Long-Term Study of Gabapentin Enacarbil (GEn, XP13512) vs. Placebo in Patients With Restless Legs Syndrome.
NCT00311363COMPLETEDPHASE3
327 participants
INTERVENTIONAL
Started: Apr 1, 2006
Simulated Driving Study in Restless Legs Syndrome
NCT01332318COMPLETEDPHASE2
130 participants
INTERVENTIONAL
Albuquerque, United States
Started: Apr 1, 2007
Drug Drug Interaction Study With Gabapentin Enacarbil and Morphine
NCT01476124COMPLETEDPHASE1
18 participants
INTERVENTIONAL
Austin, United States
Started: Aug 1, 2011
Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome
NCT01332305COMPLETEDPHASE2
217 participants
INTERVENTIONAL
Dallas, United States
Started: Jan 1, 2007
Showing 20 of 26 total trials