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Related Experiment Videos

Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS.

C A Kushida1, P M Becker, A L Ellenbogen

  • 1Stanford University Center of Excellence for Sleep Disorders, Stanford, CA 94305-5730, USA. clete@stanford.edu

Neurology
|February 4, 2009
PubMed
Summary

Related Concept Videos

Blind Procedures02:07

Blind Procedures

Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which child was...
Blinding01:11

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.

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XP13512 significantly improved restless legs syndrome (RLS) symptoms in adults compared to placebo. This nondopaminergic agent was generally well-tolerated, offering a new treatment option for moderate to severe RLS.

Area of Science:

  • Neurology
  • Clinical Pharmacology
  • Sleep Medicine

Background:

  • Restless Legs Syndrome (RLS) is a neurological disorder characterized by an irresistible urge to move the legs.
  • Primary RLS affects a significant portion of the adult population, impacting quality of life.
  • Current treatments for RLS have limitations, necessitating the development of novel therapeutic agents.

Purpose of the Study:

  • To evaluate the efficacy and tolerability of XP13512/GSK1838262, a nondopaminergic agent, in adults with moderate to severe primary RLS.
  • To determine if XP13512 improves key symptom measures and patient-reported outcomes compared to placebo.

Main Methods:

  • A 12-week, multicenter, randomized, double-blind, placebo-controlled trial was conducted.
  • Participants received either XP13512 (1,200 mg daily) or a placebo, taken with food in the evening.

Related Experiment Videos

  • Coprimary endpoints included the change in International Restless Legs Scale (IRLS) score and the proportion of responders based on the Clinical Global Impression-Improvement scale.

    • Main Results:

    • XP13512 treatment resulted in a significantly greater mean reduction in IRLS total score compared to placebo (-13.2 vs. -8.8).
    • A higher percentage of patients on XP13512 were classified as responders (76.1%) versus placebo (38.9%).
    • Adverse events like somnolence and dizziness were mild to moderate and generally resolved, with higher incidence in the XP13512 group.

    Conclusions:

    • Daily oral administration of XP13512 (1,200 mg) demonstrated significant efficacy in improving RLS symptoms.
    • The agent was generally well-tolerated in adults with moderate to severe primary RLS.
    • XP13512 represents a promising therapeutic option for managing RLS.