Appendix C. Table 1Summary of study baseline characteristics for placebo-controlled, dopamine agonist trials (n=16)

CharacteristicMean (range)
Unless otherwise note
Number of trials reporting
Total number of patients evaluated4861 (22 to 505)16
Age of subjects, years55.1 (50.9 to 60.0)16
Women, %65 (55 to 74)16
Race/ethnicity, white %96 (86 to 100)7 h,jo
RLS disease duration, years8.9 (2.1 to 22.8)13 a,b,dm,o
Baseline IRLS total score (range 0 to 40)*25.1 (22.0 to 28.6)16
Patients with very severe disease, % (number of patients)17.2 (3.3 to 37.1)3 m,n,p
Studies with a mean IRLS score >30, indicating severe disease*none-
Previous RLS therapy, %41.0 (21.8 to 80.8)11 a,d,hp
Patients who failed (experienced augmentation or rebound) with previous treatment, % (number of patients)NRNR**
Trials evaluating pramipexole, % (number of patients)37 (1794)5 hl
Trials evaluating ropinirole, % (number of patients)35 (1696)7 ag
Trials evaluating rotigotine (transdermal patch),% (number of patients)28 (1371)4 mp
Crossover trials, % (number of patients)0.5 (22)1 a
Trial duration (double-blind phase), weeks15 (6 to 28)16
# of trials with a duration ≥6 months (%, number of patients)3 i,m,n (37, n=1655)
# of trials conducted in the Europe (%, number of patients)9 f,g,il, np (59, n=2867)
# of trials conducted in the US (%, number of patients)5 ac,g,l (33, n=1615)
# of trials conducted in the Australia, Europe and North America, (%, number of patients)2 d,e (8, n=379)
*

IRLS = International Restless Legs Scale: Scoring criteria are: Mild (score 1–10); Moderate (score 11–20); Severe (score 21–30); Very severe (score 31–40).

**

2 pramipexole trials (Högl, Winkelman) and 5 ropinirole trials (Bogan, Kushida, Montplaisir, Trenkwalder 2004, Walters) reported augmentation/end-of-dose rebound during previous RLS treatment as an exclusion criterion.

a

Adler;

b

Bogan;

c

Kushida;

d

Waters;

e

Montplasir;

f

Trenkwalder 2004a;

g

Benes Ropinirole

h

Winkelman;

i

Högl;

j

Montagna;

k

Ferini-Strambi;

l

Oertel 2007; Pramipexole

m

Hening;

n

Trenkwalder 2008;

o

Oertel 2010;

p

Oertel 2008;Rotigotine

IRLS = International Restless Legs Scale: Scoring criteria are: Mild (score 1–10); Moderate (score 11–20); Severe (score 21–30); Very severe (score 31–40).

2 pramipexole trials (Högl, Winkelman) and 5 ropinirole trials (Bogan, Kushida, Montplaisir, Trenkwalder 2004, Walters) reported augmentation/end-of-dose rebound during previous RLS treatment as an exclusion criterion.

Adler;

Bogan;

Kushida;

Waters;

Montplasir;

Trenkwalder 2004a;

Winkelman;

Högl;

Montagna;

Oertel 2007; Pramipexole

Hening;

Trenkwalder 2008;

Oertel 2010;

Oertel 2008;Rotigotine

From: Appendix C, Baseline Characteristics Tables

Cover of Treatment for Restless Legs Syndrome
Treatment for Restless Legs Syndrome [Internet].
Comparative Effectiveness Reviews, No. 86.
Wilt TJ, MacDonald R, Ouellette J, et al.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.