Simulated Driving Study in Restless Legs Syndrome
Information source: XenoPort, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Restless Legs Syndrome
Intervention: XP13512 (Drug); Diphenhydramine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: XenoPort, Inc. Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: A Randomized, Double Blind, Active- and Placebo-Controlled, Parallel Group Safety Study Assessing Simulated Driving Performance in XP13512-(GSK1838262) Treated Patients With Restless Legs Syndrome
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax)
Secondary outcome: 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)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 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 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 Number of Participants With the Indicated Number of Simulated Crashes on Days 14 (Evening), 15 (Morning After Dose), and 16 (Tmax) 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 Brake Reaction Time 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 the Alertness Visual Analog Scale (VAS) Score Change From Baseline (Day -1) to Day 14 (Evening) in the Epworth Sleepiness Scale (ESS) Total Score 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) on the Brief Assessment of Cognition (BAC) Composite Score 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) on the Brief Assessment of Cognition (BAC) Scaled Verbal Memory Test Score 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) on the Brief Assessment of Cognition (BAC) Scaled Digit Sequencing Score (DSS) 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) on the Brief Assessment of Cognition (BAC) Scaled Token Motor Task Test Score 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) on the Brief Assessment of Cognition (BAC) Scaled Verbal Fluency Test Score Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Symbol Coding Test Score Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Tower of London (TOL) Score Mean Change From Baseline (Day -1) at Day 14 in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score Number of Participants in Each Category of the Investigator-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14 Number of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated CGI-I at Day 14 Number of Participants in Each Category of the Participant-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14 Number of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Day 14 Median Time to Onset of a Participant's First RLS Symptoms Using the 24-hour RLS Symptom Record at Day 14 Percentage of Participants With no Reported RLS Symptoms During the 24-hour RLS Record at Day 14 Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Day 14 Number of Participants With the Indicated Post Sleep Questionnaire (PSQ) Responses at Day 14 Mean 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) on the Pittsburgh Sleep Diary (PghSD) Sleep Onset Items 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 the Pittsburgh Sleep Diary (PghSD) Total Sleep Time Item Mean 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 the Pittsburgh Sleep Diary (PghSD) Sleep Quality
Detailed description:
This study was a multicenter, randomized, double blind, active and placebo controlled,
parallel group study. Eligible subjects were randomized in a 1: 1:1: 1 ratio to 1 of the
following 4 treatment groups:
A) XP13512 Placebo + Diphenhydramine Placebo (Pbo) B) XP13512 1200 mg/day +
Diphenhydramine Placebo (1200 mg) C) XP13512 1800 mg/day + Diphenhydramine Placebo (1800
mg) D) XP13512 Placebo + 50 mg Diphenhydramine (Pbo/DPH)
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Locations and Contacts
GSK Investigational Site, Albuquerque, New Mexico 87108, United States
Additional Information
Starting date: April 2007
Last updated: July 15, 2013
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