Last updated: 11/03/2018 11:46:49

A Randomized, Double Blind, Active- and Placebo-Controlled, Parallel Group Safety Study Assessing Simulated Driving Performance in XP13512-(GSK1838262) Treated Patients with Restless Legs SyndromeXP083

GSK study ID
111463
See study documents
Clinicaltrials.gov ID
NCT01332318
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

change in Baseline-adjusted mean Lane Position Variability (LPV)

Timeframe: Day 16

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Diphenhydramine
  • Drug: XP13512
  • Device: Placebo
    • Enrollment:
    130
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Restless Legs Syndrome
    Product
    gabapentin enacarbil
    Collaborators
    Not applicable
    Study date(s)
    April 2007 to November 2007
    Type
    Interventional
    Phase
    2/3

    Participation criteria

    Sex
    Female & Male
    Age
    21 - 65 Year
    Accepts healthy volunteers
    none
    • Men or women who were 21 through 65 years of age and fluent in English;
    • Subjects with RLS, based on the IRLSSG Diagnostic 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;
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-09-11

    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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