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ASP8825 - Study in Patients With Restless Legs Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00530530
First received: September 13, 2007
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Restless Legs Syndrome
Drug: ASP8825
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The change of the International Restless Legs Syndrome rating scale score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator-related Clinical Global Impression of Improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient- related Clinical Global Impression of Improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The Pittsburgh sleep quality index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The SF-36 Health Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The Restless Legs Syndrome QOL Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The Medical Outcomes Study sleep scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 474
Study Start Date: September 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided by Astellas Pharma Inc

Additional 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
Study First Received: September 13, 2007
Last Updated: October 28, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

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

ClinicalTrials.gov processed this record on November 25, 2014