PMID- 15111679
OWN - NLM
STAT- MEDLINE
DCOM- 20040810
LR  - 20190514
IS  - 1526-632X (Electronic)
IS  - 0028-3878 (Linking)
VI  - 62
IP  - 8
DP  - 2004 Apr 27
TI  - Efficacy of pergolide in treatment of restless legs syndrome: the PEARLS Study.
PG  - 1391-7
AB  - OBJECTIVE: To evaluate the short- and long-term safety and efficacy of pergolide 
      therapy for restless legs syndrome (RLS) in a double-blind, placebo-controlled, 
      randomized trial (Pergolide European Australian RLS [PEARLS] study). METHODS: We 
      randomized 100 patients with idiopathic RLS were randomized to pergolide, 0.25 to 
      0.75 mg, in the evening or placebo for 6 weeks (phase 1); thereafter, patients 
      with response on the Patient Global Impression (PGI) scale continued on 
      double-blind pergolide or placebo, and nonresponders received open-label 
      pergolide up to 1.5 mg/d for 12 months of treatment (phase 2). Sleep efficiency 
      (SE) and periodic limb movements during sleep (PLMS) arousal index were monitored 
      by centrally evaluated polysomnography (PSG). The severity of RLS was assessed 
      using the validated International RLS Scale (IRLS). RESULTS: In phase 1 (change 
      from baseline to week 6), pergolide reduced PLMS arousal index vs placebo (mean 
      +/- SD, -12.6 +/- 10.0 vs -3.6 +/- 15.9; p = 0.004), and SE did not improve (mean 
      +/- SD, +11.3 +/- 11.9% vs +6.1 +/- 18.6%; p = 0.196). Pergolide improved RLS 
      severity score (-12.2 +/- 9.9 vs -1.8 +/- 7.5 placebo; p < 0.001) and was 
      associated with a higher PGI response (68.1% vs 15.1%; p < 0.001) and 
      improvements in periodic limb movements (PLM) index, PGI improvement scale, 
      Clinical Global Impression improvement, and IRLS (all p < 0.001), 
      patient-reported SE (p = 0.019), and quality of sleep (p < 0.001). After 12 
      months (phase 2), double-blind pergolide maintained improvements in PLMS arousal 
      index and PLM index. Placebo patients switched to open-label pergolide in phase 2 
      exhibited marked improvements in these measures that were maintained at 12 
      months. Pooled results from the blinded and open-label pergolide groups 
      demonstrated improvements at 12 months in the PLMS arousal index (p = 0.028) and 
      PLM index (p < 0.0001) compared with placebo. Nausea and headache were more 
      frequent with pergolide than with placebo treatment. CONCLUSIONS: Pergolide 
      substantially improves periodic limb movement measures and subjective sleep 
      disturbance associated with restless legs syndrome. Low-dose pergolide was well 
      tolerated and maintained its efficacy in the long term.
FAU - Trenkwalder, C
AU  - Trenkwalder C
AD  - Department of Clinical Neurophysiology, Georg August University, Goettingen, 
      Germany. ctrenkw@gwdg.de
FAU - Hundemer, H-P
AU  - Hundemer HP
FAU - Lledo, A
AU  - Lledo A
FAU - Swieca, J
AU  - Swieca J
FAU - Polo, O
AU  - Polo O
FAU - Wetter, T C
AU  - Wetter TC
FAU - Ferini-Strambi, L
AU  - Ferini-Strambi L
FAU - de Groen, H
AU  - de Groen H
FAU - Quail, D
AU  - Quail D
FAU - Brandenburg, U
AU  - Brandenburg U
CN  - PEARLS Study Group
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Neurology
JT  - Neurology
JID - 0401060
RN  - 0 (Dopamine Agonists)
RN  - 24MJ822NZ9 (Pergolide)
SB  - IM
MH  - Abdominal Pain/chemically induced
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Dopamine Agonists/adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Pergolide/adverse effects/*therapeutic use
MH  - Prospective Studies
MH  - Restless Legs Syndrome/complications/*drug therapy
MH  - Sleep Arousal Disorders/complications/drug therapy
MH  - Treatment Outcome
EDAT- 2004/04/28 05:00
MHDA- 2004/08/11 05:00
CRDT- 2004/04/28 05:00
PHST- 2004/04/28 05:00 [pubmed]
PHST- 2004/08/11 05:00 [medline]
PHST- 2004/04/28 05:00 [entrez]
AID - 10.1212/01.wnl.0000124465.20878.84 [doi]
PST - ppublish
SO  - Neurology. 2004 Apr 27;62(8):1391-7. doi: 10.1212/01.wnl.0000124465.20878.84.