Author, year
Design
Duration
Interventionb
N. patients
F:M
Agea
IRLSG scorea
Disease durationa
Outcome
Results
Allen 2014
RCT
52 weeks
Pregabalin 300 mg versus pramipexole 0.25 mg versus pramipexole 0.50 mg
540, ITT
1.6:1
55.0
4.6
IRLS SS improvement
(non-inferiority)
Pregabalin > pramipexole 0.25 mg
pregabalin > pramipexole 0.50 mg
CGI improvement
(non-inferiority)
Pregabalin = pramipexole 0.50 mg > pramipexole 0.25 mg
Drop out
Pregabalin 51%
pramipexole 0.25 46%
pramipexole 0.50 49%
Augmentation
Pregabalin 1.7%
pramipexole 0.25 mg 6.6%
pramipexole 0.50 mg 9.0%
Inoue 2010
ObsLRS
52 weeks
Pramipexole 0.125–0.75 mg, flexible doses
0.31 ± 0.27 mg
140
1.3:1
52.6 ± 14.0
10.1 ± 7.8
0.1 ± 0.4
IRLS SS, CGI, PSQI, ESS
↓ Mean IRLSGSS
↓ Mean CGI
↓ Mean PSQI
↓ Mean ESS
Silber 2003
ObsLRS
27 months
Pramipexole 0.125–4.5 mg, flexible doses
0.38 mg
60
1.5:1
57.7 years
(25–82 years)
–
–
Subjective RLS symptoms
67% completely effective
27% partially effective
7% ineffective
Augmentation
33%
Lipford 2012
ObsLRS
7.96 ± 3.73 years (0.6–12 years)
Pramipexole 0.25–4.5 mg, flexible doses
0.63 mg
50
1.6:1
–
–
–
Subjective RLS symptoms
60% partially or totally effective
28% need to add another drug
12% ineffective
Winkelman 2004
ObsLRS
21.2 ± 11.4 months
Pramipexole 0.125–1.0 mg, flexible doses 0.47 ± 0.22 mg
59
1.4:1
60.8 ± 14.4
–
–
Augmentation
Tolerance
32%
46%
Montplaisir 2006
ObsLRS
>1 year
Pramipexole (dose not specified)
195
1.3:1
55.1 ± 12.1
–
23.6
Discontinuation
22.1%
13.3% for inefficacy
30.5 ± 10.5 months
Pramipexole 0.125–2.25 mg, flexible doses
Median 0.59 ± 0.31 mg
152
1.2:1
53 ± 11.8
–
23.2
Subjective severity of RLS symptoms
Mean ↓ of 80.0% (±20.8)
Severity ↓ of > 50% in 94.7% points
130
(subgroup)
–
–
–
Subjective sleep measures
86.9% ↓ sleep latency
20.4% ↓ nocturnal awakenings
91.4% ↑ overall sleep quality
Garcia-Borreguero 2007
ObsLRS
52 weeks
Ropinirole 0.25–4.0 mg, flexible doses
1.64 ± 1.0 mg
309
1.5:1
56.5 ± 11.0
22.0 ± 8.7
–
Augmentation
Discontinuation
11.7%
19.0%
3.5% for inefficacy
233 (subgroup)
–
–
–
IRLS SS, CGI
↓ IRLS SS −10.0 points
71.9% CGI improvement
Ondo 2004
ObsLRS
39.2 ± 20.9 months
Pramipexole (n = 40)
ropinirole (n = 19)
pergolide (n = 12)
flexible doses
LDED: 0.79 ± 0.55 mg
83
1.6:1
56.8 ± 11.5
–
22.0
Subjective severity of RLS symptoms
19.3% need to add another drug
24.1% Shift among pramipexole, ropinirole, or pergolide
Augmentation
Discontinuation
28.9%
12%
2.4% for inefficacy
Oertel 2013
ObsLRS
5 years
Rotigotine stable dose after titration: 2.4 ± 1.2 mg
end: 3.1 ± 1.1
295
2.0:1
58.3 ± 10.1
27.7 ± 6.0
11.0
(6.0–24.0)
IRLS SS, CGI, RLS-6, RLS-QoL
↓ IRLS SS −18.7 ± 9.5 points
↓ CGI item 1 −2.8 ± 1.1
96% much or very much improvement CGI item 2
↓ RLS-6 scale
↓ RLS-QoL −18.4 ± 13.2
Augmentation
Discontinuation
13%
57%
11% for inefficacy
Subjective severity of RLS symptoms
61% need dose adjustment (not say up or down)
VonScheele 1990
ObsLRS
2 years
Levodopa-carbidopa
Start: 50–250 mg
Median: 100 mg
30 responders
1:1
59
(10–81)
–
Subjective RLS symptoms
86.7 L-DOPA keep to be efficient
30.0% need dose increase
26.7% kept the same dose
30.0% a decreased dose was sufficient
Discontinuation
13.3%
6.7% for inefficacy
Trenkwalder 2003
ObsLRS
12 months
Levodopa-benserazide (RR + SR, flexible doses)
Final: 314 ± 133 mg (150–640) (n = 20)
23, ITT
2.7:1
56 ± 10 (31–72)
20
Subjective sleep measures
Satisfaction with sleep +3.5 ± 1.9
Sleep latency (min) 131±152
Wake periods during night (min) −234 ± 129
Total sleep time +190 ± 136
Subjective RLS measures
Severity at time falling asleep −6.5 ± 3.4
Severity during the night −6.0 ± 3.5
CGI
Item 2 change ↑ in 39% points
Item 3 change ↑ in 56% points
Augmentation
Discontinuation
34.8%
56.5%
4.3% for inefficacy
21.3% for RLS severity increase
Ellenbogen 2012c
ObsLRS
52 weeks
Gabapentin enacarbil
flexible doses
Final: 1267.0 ± 409.8 mg (600–1800)
573
1.8:1
50.2 ± 11.9
(19–79)
10.4 ± 8.13
IRLS score
↓ IRLS SS −2.4 points
(Mean ESS at end 8.0 ± 8.29)
ObsLRS
52 weeks
Gabapentin enacarbil
flexible doses
Final: 1197.0 ± 426.4 mg (600–1800)
197 (subgroup)
1.5:1
49.5 ± 12.0(19–77)
13.8 ± 7.9
IRLS score
ESS
Discontinuation
↓ IRLS SS 8.4 ± 7.7 (−5.4 points)
−2.0 points
1.5% for inefficacy
ObsLRS
64 weeks
Gabapentin enacarbil
flexible doses
Final: 1303.7 ± 396.5 mg (600–1800)
376 (subgroup)
1.4:1
50.6 ± 11.8 (20–79)
23.2 ± 5.1
IRLS score
ESS
Discontinuation
↓ IRLS SS 7.8 ± 8.9 (−15.2 ± 8.9 points)
(not available)
2.3% for inefficacy
Inoue 2012
ObsLRS
52 weeks
Gabapentin enacarbil
flexible doses
Initial: 1150.3 ± 156.6 mg (600–1800)
Final: not specified
181
1.1:1
54.9 ± 12.2
24.4 ± 0.4
10.6 ± 11.0
IRLS score
PSQI
SF-36
Discontinuation
Dose adjustment
↓ IRLS SS -18.0 ± 0.6 points
↓ PSQI −3.6 points
↓ SF−36
0.6% for inefficacy
Dose increase in 2.2%
Dose decrease in 10.0%
Ondo 2005
ObsLRS
23 ± 12 months
(4–44)
Methadone flexible doses
Initial: 13.0 ± 5.9 mg (5–30)
Final:15.5 ± 7.7 mg (5–40)
27
1.1:1
54.8 ± 14.4
23
Subjective efficacy
Discontinuation
63% efficacy maintained
37%
7.4% for inefficacy
Silver 2011
ObsLRS
1year/10 years
Methadone
At 6 months median dose 10 ± mg
Related posts:
Health-Related Quality of Life and Depression Symptom Measures for the Assessment of Treatment in Restless Legs Syndrome/Willis–Ekbom Disease
Cognitive Functioning
Outcome and Mortality in Renal Failure Related RLS
Management of Augmentation
Sleep Impact: Insomnia, Hypersomnia, Sleep Attacks, and Circadian Disorders
Impulse Control Behavior in Movement Disorders: Focus on Restless Leg Syndrome
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