Last updated: 11/07/2018 03:25:06

A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Assess the Efficacy, Safety, and Pharmacokinetics of XP13512 (GSK1838262) in Patients with Restless Legs SyndromeXP081

GSK study ID
111462
See study documents
Clinicaltrials.gov ID
NCT01332305
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: This was a multicenter, randomized, double blind, placebo controlled, parallel group study, comparing 4 doses of GEn (XP13512) with placebo given once daily to subjects with RLS. Eligible subjects were randomized in equal numbers into 1 of 5 treatment groups (GEn 600 mg, 1200 mg, 1800 mg, or 2400 mg or placebo) for 12 weeks of treatment. The objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in subjects with Restless Legs Syndrome (RLS). Data from this study will be utilized as part of a larger pharmacokinetic (PK) pharmacodynamic (PD) analysis of data from several studies (XP084/RXP111495) that are part of the GEn RLS clinical development program. Safety and tolerability were also assessed.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

pharmacokinetic exposure to gabapentin

Timeframe: Week 4 and 12

Secondary outcomes:
Not applicable
Interventions:
Drug: GEn (XP13512/GSK1838262)
Drug: placebo comparator
Enrollment:
217
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Samantha Warren, Sarah Kavanagh, Susan VanMeter, Ron Barrett. Comparison of Multiple Doses of Gabapentin Enacarbil versus Placebo in Subjects with Moderate-to-Severe Primary Restless Legs Syndrome: An Integrated Analysis of Three 12-Week Studies. [CNS Drugs]. 2012;26(9):773-780.
Medical condition
Restless Legs Syndrome
Product
gabapentin enacarbil
Collaborators
Xenoport
Study date(s)
January 2007 to January 2008
Type
Interventional
Phase
2/3

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
  • Men or women at least 18 years of age
  • RLS, based on the IRLSSG Diagnostic Criteria
  • a sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS
  • history of RLS symptom augmentation or end of dose rebound with previous dopamine agonist treatment
Inclusion and exclusion criteria
Inclusion criteria:
  • Men or women at least 18 years of age
  • RLS, based on the IRLSSG Diagnostic Criteria
  • History of RLS symptoms occurring at least 15 nights in the month prior to Screening or, if on RLS treatment, this frequency of symptoms must have been applicable prior to start of treatment
  • Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights
  • Total RLS severity score of 15 or greater on the IRLS Rating Scale
  • If taking dopamine agonists, gabapentin, or other treatments for RLS (e.g., opioids, benzodiazepines) medications must have been discontinued at least 2 weeks prior to Screening;
  • If taking any prescription medication, therapy must have been stabilized for at least 3 months prior to Screening with no anticipated changes for the duration of the study;
  • Body Mass Index (BMI) of 34 or below
  • estimated creatinine clearance of at least 60 mL/min
Exclusion criteria:
  • a sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS
  • history of RLS symptom augmentation or end of dose rebound with previous dopamine agonist treatment
  • neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson’s disease, multiple sclerosis, dyskinesias, and dystonias);
  • other clinically significant or unstable medical condition or conditions which could affect RLS treatment efficacy assessments
  • serum ferritin level below 20 ng/mL
  • currently suffering from moderate or severe depression using the Diagnostic and Statistical Manual of Mental Disorders and Treatment IV (DSM IV TR)

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-10-01

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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