Evidence map›Paper›PMID 27067343›Full record

Trial reportCNS drugs2016

The Effect of Gabapentin Enacarbil on Quality of Life and Mood Outcomes in a Pooled Population of Adult Patients with Moderate-to-Severe Primary Restless Legs Syndrome.

Alon Y Avidan, Daniel Lee, Margaret Park, Mark J Jaros, Gwendoline Shang, Richard Kim

3 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in CNS drugs, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00298623 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.

TypeinterventionalSponsorXenoPort, Inc.Ran2006 to 2007Enrolled222ConditionsRestless Legs SyndromeArmsXP13512 (GSK1838262), placebo
NCT00365352 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.

TypeinterventionalSponsorXenoPort, Inc.Ran2006 to 2007Enrolled325ConditionsRestless Legs SyndromeArmsXP13512 600MG, XP13512 1200MG, PLACEBO
NCT01332305 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Assess the Efficacy, Safety, and Pharmacokinetics of XP13512 (GSK1838262) in Patients With Restless Legs Syndrome

TypeinterventionalSponsorXenoPort, Inc.Ran2007 to 2008Enrolled217ConditionsRestless Legs SyndromeArmsGEn (XP13512/GSK1838262), Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Alon Y AvidanUCLA, Sleep Disorders Center and Department of Neurology, Dave Geffen School of Medicine at UCLA, 710 Westwood Blvd., Room 1-145 RNRC, Los Angeles, CA, 90095-1769, USA. avidan@mednet.ucla.edu.
Daniel LeeBaptist Health Neurology, 789 Eastern Bypass Suite 16, Richmond, KY, 40475, USA.
Margaret ParkChicago Sleep Health, 444 N. Michigan Avenue, Suite 1200, Chicago, IL, 60611, USA.
Mark J JarosSummit Analytical, LLC, 2422 Stout Street, Denver, CO, 80205, USA.
Gwendoline ShangXenoPort, Inc., 3410 Central Expressway, Santa Clara, CA, 95051, USA.
Richard KimXenoPort, Inc., 3410 Central Expressway, Santa Clara, CA, 95051, USA.
California Center for Sleep Disorders · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim was to assess gabapentin enacarbil (GEn) treatment effects on quality of life (QOL) and mood in adults with moderate-to-severe primary restless legs syndrome (RLS).

methodsData were pooled from three placebo-controlled, randomized, double-blind, 12-week trials for adults receiving GEn (600 mg or 1200 mg) or placebo once daily. QOL was assessed with the RLS QOL questionnaire in two studies. Mood was examined with the Profile of Mood States Brief Form (POMS-B), and as an exploratory analysis with International Restless Legs Scale (IRLS) item 9 (daily affairs) and item 10 (mood disturbance) across all three studies. Mood and QOL were secondary endpoints in the individual clinical trials. No adjustments for multiplicity were applied.

resultsThe QOL analysis modified intent-to-treat (MITT) population included 541 adults (placebo, n = 204; GEn 600 mg, n = 114; GEn 1200 mg, n = 223). Both GEn doses significantly improved QOL versus placebo (week 12; p < 0.01). The mood analysis MITT population included 671 adults (placebo, n = 244; GEn 600 mg, n = 161; GEn 1200 mg, n = 266). GEn 600 mg significantly improved POMS vigor-activity versus placebo (week 12; p < 0.05); other POMS criteria were not significantly affected. GEn 1200 mg significantly improved POMS scores for total mood disturbance, depression-dejection, fatigue-inertia, vigor-activity, and confusion-bewilderment versus placebo at week 12 (p < 0.05); tension-anxiety and anger-hostility were not significantly affected. Both GEn doses significantly improved IRLS item 9 and item 10 versus placebo at week 12 (p < 0.05). The most frequent treatment-emergent adverse events with GEn were somnolence and dizziness.

conclusionsGEn (600 mg and 1200 mg) once daily significantly improved QOL in adults with moderate-to-severe primary RLS at all time points examined. While the only POMS item significantly improved by GEn 600 mg versus placebo at week 12 was vigor-activity, GEn 1200 mg significantly improved total mood disturbance and several other POMS items versus placebo at week 12. Both QOL and mood improvements were numerically greater with GEn 1200 mg versus 600 mg. TRIAL REGISTRATIONS: Clinicaltrials.gov identifiers NCT00298623, NCT00365352, NCT01332305.

Indexed as

Quality of LifeAffectCarbamatesDose-Response Relationship, DrugDouble-Blind MethodFemalegamma-Aminobutyric AcidHumansMaleMembrane Transport ModulatorsMiddle AgedPsychiatric Status Rating ScalesPsychotropic DrugsRestless Legs SyndromeSeverity of Illness IndexTreatment Outcome1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acidCarbamatesgamma-Aminobutyric AcidMembrane Transport ModulatorsPsychotropic Drugs

Identifiers

PMID27067343
OpenAlexW2340554712

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.