PMID- 21242741
OWN - NLM
STAT- MEDLINE
DCOM- 20110729
LR  - 20220330
IS  - 1537-162X (Electronic)
IS  - 0362-5664 (Linking)
VI  - 34
IP  - 1
DP  - 2011 Jan-Feb
TI  - A 52-week study of gabapentin enacarbil in restless legs syndrome.
PG  - 8-16
LID - 10.1097/WNF.0b013e3182087d48 [doi]
AB  - OBJECTIVES: This open-label, multicenter, 52-week extension study (NCT00333359) 
      assessed the long-term safety and efficacy of gabapentin enacarbil in subjects 
      with moderate-to-severe primary restless legs syndrome (RLS). METHODS: Subjects 
      had completed one of 4 randomized, double-blind parent studies 
      (XP052/XP053/XP081/XP083). Gabapentin enacarbil 1200 mg was administered once 
      daily at 5 pm; dose adjustments to 600 or 1800 mg were permitted based on 
      investigator judgment. Safety assessments included adverse events (AEs), vital 
      signs, clinical laboratory tests, and electrocardiograms. Efficacy evaluations 
      included the International Restless Legs Scale total score and the 
      investigator-rated Clinical Global Impression-Improvement scale, at week 52 last 
      observation carried forward. RESULTS: The safety population comprised 573 
      subjects; 386 (67.4%) completed the study. Treatment-emergent AEs were reported 
      by 80.1% of subjects and led to withdrawal in 10.3% of subjects; most (67.7%) 
      were mild or moderate in intensity. The most common AEs were somnolence and 
      dizziness (19.7% and 11.5% of subjects). Twenty subjects (3.5%) reported serious 
      AEs; one subject died (fall, 25 days after stopping gabapentin enacarbil, judged 
      not treatment related). No serious AE occurred in more than 1 subject. No 
      clinically relevant changes were reported in vital signs, laboratory parameters, 
      or electrocardiograms. At week 52 last observation carried forward, the mean (SD) 
      change from parent study baseline in International Restless Legs Scale total 
      score was -15.2 (8.85 [parent study baseline score, 23.2 (5.03)]), and 84.8% of 
      subjects were Clinical Global Impression-Improvement responders ("much improved" 
      or "very much improved"). CONCLUSIONS: Gabapentin enacarbil was generally safe 
      and well tolerated and improved RLS symptoms in subjects with moderate-to-severe 
      primary RLS for up to 64 weeks of treatment.
FAU - Ellenbogen, Aaron L
AU  - Ellenbogen AL
AD  - Quest Research Institute, Farmington Hills, MI 48334, USA. 
      aellenbogen@comcast.net
FAU - Thein, Stephen G
AU  - Thein SG
FAU - Winslow, David H
AU  - Winslow DH
FAU - Becker, Philip M
AU  - Becker PM
FAU - Tolson, Jerry M
AU  - Tolson JM
FAU - Lassauzet, Marie-Liesse
AU  - Lassauzet ML
FAU - Chen, Dan
AU  - Chen D
LA  - eng
SI  - ClinicalTrials.gov/NCT00333359
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Neuropharmacol
JT  - Clinical neuropharmacology
JID - 7607910
RN  - 0 (1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic 
      acid)
RN  - 0 (Carbamates)
RN  - 0 (GABA Agents)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Carbamates/*adverse effects/*therapeutic use
MH  - Chronic Disease
MH  - Female
MH  - GABA Agents/*adverse effects/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Restless Legs Syndrome/diagnosis/*drug therapy
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Young Adult
MH  - gamma-Aminobutyric Acid/adverse effects/*analogs & derivatives/therapeutic use
EDAT- 2011/01/19 06:00
MHDA- 2011/07/30 06:00
CRDT- 2011/01/19 06:00
PHST- 2011/01/19 06:00 [entrez]
PHST- 2011/01/19 06:00 [pubmed]
PHST- 2011/07/30 06:00 [medline]
AID - 00002826-201101000-00003 [pii]
AID - 10.1097/WNF.0b013e3182087d48 [doi]
PST - ppublish
SO  - Clin Neuropharmacol. 2011 Jan-Feb;34(1):8-16. doi: 10.1097/WNF.0b013e3182087d48.