ASP8825 - Study in Patients With Restless Legs Syndrome

October 28, 2014 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

474

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chugoku, Japan
      • Hokkaido, Japan
      • Kansai, Japan
      • Kanto, Japan
      • Kyusyu, Japan
      • Tohoku, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 4
Drug: Placebo
oral
Experimental: 1
Dose 1
Drug: ASP8825
oral
Other Names:
  • XP13512
Experimental: 2
Dose 2
Drug: ASP8825
oral
Other Names:
  • XP13512
Experimental: 3
Dose 3
Drug: ASP8825
oral
Other Names:
  • XP13512

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of the International Restless Legs Syndrome rating scale score
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigator-related Clinical Global Impression of Improvement
Time Frame: 12 weeks
12 weeks
Patient- related Clinical Global Impression of Improvement
Time Frame: 12 weeks
12 weeks
The Pittsburgh sleep quality index
Time Frame: 12 weeks
12 weeks
The SF-36 Health Survey
Time Frame: 12 weeks
12 weeks
The Restless Legs Syndrome QOL Questionnaire
Time Frame: 12 weeks
12 weeks
The Medical Outcomes Study sleep scale
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (Estimate)

September 17, 2007

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8825-CL-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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