Simulated Driving Study in Restless Legs Syndrome

NCT01332318 | Completed Phase 2 Results DMC

• 2 other identifiers: 111463XP083
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily dose of placebo (2 groups), XP13512 1200 mg, or XP13512 1800 mg for 16 days. On Day 16, one of the placebo groups also received one 50 mg dose of diphenhydramine (DPH) to assess the effects of an agent known to have sedative properties, while the other 3 groups received a DPH placebo.

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax)

  Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 16 mean LPV over the 1-hour drive minus the Baseline mean LPV over the 1-hour drive. The Day 16 measurement is at the time of maximum concentration (Tmax) for both GEn and DPH.

  Baseline (Day -1) and Day 16

Secondary Outcomes (27)

• Change From Baseline (Day -1) to Day 14 (Evening) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Lane Position Variability (LPV)

  Baseline (Days -1 and 1) and Days 14 and 15

• Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Lane Position

  Baseline (Days -1 and 1) and Days 14, 15, and 16

• Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Speed Variability

  Baseline (Day -1) and Days 14 and 16; baseline (Day 1) and Day 15

• Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Speed

  Baseline (Days -1 and 1) and Days 14, 15, and 16

• Number of Participants With the Indicated Number of Simulated Crashes on Days 14 (Evening), 15 (Morning After Dose), and 16 (Tmax)

  Days 14, 15, and 16

Study Arms (4)

Placebo

PLACEBO COMPARATOR

XP13512 Placebo + Diphenhydramine Placebo

Drug: Placebo

XP13512 1200 mg

EXPERIMENTAL

XP13512 1200 mg/day + Diphenhydramine Placebo

Drug: XP13512

XP13512 1800 mg

EXPERIMENTAL

XP13512 1800 mg/day + Diphenhydramine Placebo

Drug: XP13512

Placebo + Diphenhydramine

ACTIVE COMPARATOR

XP13512 Placebo + 50 mg Diphenhydramine

Drug: Diphenhydramine; Drug: Placebo

Interventions

XP13512 DRUG

XP13512 once daily for 16 days

Also known as: GSK1838262, Gabapentin Enacarbil (GEn)

XP13512 1200 mg; XP13512 1800 mg

Diphenhydramine DRUG

one 50 mg dose of diphenhydramine (DPH) on day 16

Placebo + Diphenhydramine

Placebo DRUG

XP13512 placebo once daily for 16 days

Placebo; Placebo + Diphenhydramine

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women who were 21 through 65 years of age and fluent in English;
• Subjects with RLS, based on the IRLSSG Diagnostic Criteria;
• Currently a licensed and experienced driver who has driven an average of 3 or more times/week for the past 3 years;
• Able to successfully complete the 5 minute practice simulated driving test at Screening;
• History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started;
• Total RLS severity score of 15 or greater on the IRLS Rating Scale;
• Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights Discontinuation of treatments for RLS (e.g., opioids, benzodiazepines, dopamine agonists and/or gabapentin) at least 2 weeks prior to Screening; -
• Body Mass Index of 34 or below;
• Estimated creatinine clearance of at least 60 mL/min;
• Agreed to maintain abstinence from alcohol and smoking throughout the entire study period;
• Agreed to maintain abstinence from caffeine from midnight of the day prior to and until the end of each Visit (Visits 2 to 4).

You may not qualify if:

• A sleep disorder (e.g., sleep apnea) other than RLS that may significantly affect the assessment of RLS;
• Current use of a sleeping medication or sedating medication;
• Current use of CNS stimulants;
• Neurologic disease or movement disorder;
• Other medical conditions which could affect RLS assessments;
• Significant medical history that may impair psychomotor coordination;
• Subjects who had clinically significant or unstable medical conditions;
• Serum ferritin level below 20 ng/mL;
• Subjects currently suffering from moderate or severe depression using the Diagnostic and Statistical Manual of Mental Disorders and Treatment IV (DSM IV TR);
• Subjects with a history of substance abuse (alcohol or drugs) or substance dependence within 12 months prior to enrollment;
• Shift workers or subjects who were not on normal day/night sleep cycles;
• Subjects who had smoked an average of greater than one half pack of cigarettes (or nicotine equivalent) per day within 30 days of the Screening Visit;
• Subjects who had consumed an average of \>5 cups (i.e., 40 ounces) of caffeinated beverages per day within 20 days of the Screening Visit;
• Subjects with a history of allergy to gabapentin, diphenhydramine, or XP13512 excipients

Sponsors & Collaborators

• XenoPort, Inc.: lead

Study Sites (1)

GSK Investigational Site

Albuquerque, New Mexico, 87108, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid; Diphenhydramine

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: XenoPort Call Center
• Organization: XenoPort, Inc.

877-936-6778

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: April 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 26, 2013
• Results First Posted: June 28, 2011

Record last verified: 2011-06

Locations

US (1)