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Completed

NCT Number: NCT00530530

ASP8825 - Study in Patients With Restless Legs Syndrome

To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chugoku, Japan

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About this study

Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with restless legs syndrome

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with RLS, based on the International RSL Study Group Diagnostic Criteria
  • History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started
  • Documented RLS symptoms for at least 4 of the 7 consecutive evenings/ nights during the baseline study period

Exclusion criteria

  • A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS
  • A 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

Treatment and study plan

ASP8825

Drug

oral

Other names: XP13512

Placebo

Drug

oral

Primary outcomes

  1. The change of the International Restless Legs Syndrome rating scale score

    Time frame: 12 weeks

Secondary outcomes

  1. Investigator-related Clinical Global Impression of Improvement

    Time frame: 12 weeks

  2. Patient- related Clinical Global Impression of Improvement

    Time frame: 12 weeks

  3. The Pittsburgh sleep quality index

    Time frame: 12 weeks

  4. The SF-36 Health Survey

    Time frame: 12 weeks

  5. The Restless Legs Syndrome QOL Questionnaire

    Time frame: 12 weeks

  6. The Medical Outcomes Study sleep scale

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

ASP8825 Phase ⅡStudy-A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP8825 in Patients With Restless Legs Syndrome

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 17, 2007
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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