Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome (XP081)
This study has been completed.
Sponsor:
GlaxoSmithKline
Collaborator:
XenoPort, Inc.
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332305
First received: April 7, 2011
Last updated: June 2, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Restless Legs Syndrome |
Drug: GEn (XP13512/GSK1838262) Drug: placebo comparator |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Mean Css, Max and Css, Min [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]Css, max is defined as the maximum or "peak" concentration of a drug observed after multiple administration, at steady state. Css, max is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Css, min is defined as the minimum concentration of a drug observed after its administration, in steady state. ng, nanograms; PK, pharmacokinetic; W, week; BLQ, below limit of quantitation.
- Mean Tmax and T1/2 [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]Tmax is defined as the time to the maximum or "peak" concentration of a drug observed after multiple administration. T1/2 is defined as the time to when half of the total amount of a particular substance is eliminated from the body.
- Mean AUCss [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUCss is the area under the curve during the steady-state period. The AUCss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUCss used concentration data from 0 to 24 hours at steady-state for Weeks 4 and 12.
| Enrollment: | 217 |
| Study Start Date: | January 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: GEn (XP13512/GSK1838262) 600 mg | Drug: GEn (XP13512/GSK1838262) |
| Experimental: GEn (XP13512/GSK1838262) 1200 mg | Drug: GEn (XP13512/GSK1838262) |
| Experimental: GEn (XP13512/GSK1838262) 1800 mg | Drug: GEn (XP13512/GSK1838262) |
| Experimental: GEn (XP13512/GSK1838262) 2400 mg | Drug: GEn (XP13512/GSK1838262) |
| Placebo Comparator: Placebo | Drug: placebo comparator |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01332305 History of Changes |
| Other Study ID Numbers: | 111462 |
| Study First Received: | April 7, 2011 |
| Results First Received: | April 28, 2011 |
| Last Updated: | June 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Restless Legs Syndrome Psychomotor Agitation Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Parasomnias |
Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013