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ASP8825 - Study in Patients With Restless Legs Syndrome

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ClinicalTrials.gov Identifier: NCT00530530
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: ASP8825 Drug: Placebo Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Arm Intervention/treatment
Experimental: 1
Dose 1
Drug: ASP8825
oral
Other Name: XP13512

Experimental: 2
Dose 2
Drug: ASP8825
oral
Other Name: XP13512

Experimental: 3
Dose 3
Drug: ASP8825
oral
Other Name: XP13512

Placebo Comparator: 4 Drug: Placebo
oral




Primary Outcome Measures :
  1. The change of the International Restless Legs Syndrome rating scale score [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530530


Locations
Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyusyu, Japan
Tohoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00530530     History of Changes
Other Study ID Numbers: 8825-CL-0003
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014

Keywords provided by Astellas Pharma Inc:
ASP8825
Restless legs Syndrome
XP13512

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders