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ASP8825 - Study in Patients With Restless Legs Syndrome

Primary Purpose

Restless Legs Syndrome

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

ASP8825

Placebo

About this trial

This is an interventional treatment trial for Restless Legs Syndrome focused on measuring ASP8825, Restless legs Syndrome, XP13512

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Dose 1

Dose 2

Dose 3

Outcomes

Primary Outcome Measures

The change of the International Restless Legs Syndrome rating scale score

Secondary Outcome Measures

Investigator-related Clinical Global Impression of Improvement

Patient- related Clinical Global Impression of Improvement

The Pittsburgh sleep quality index

The SF-36 Health Survey

The Restless Legs Syndrome QOL Questionnaire

The Medical Outcomes Study sleep scale

Full Information

NCT ID

NCT00530530

First Posted

September 13, 2007

Last Updated

October 28, 2014

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00530530

Brief Title

ASP8825 - Study in Patients With Restless Legs Syndrome

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 Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome

Keywords

ASP8825, Restless legs Syndrome, XP13512

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

474 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Dose 1

Arm Title

Arm Type

Experimental

Arm Description

Dose 2

Arm Title

Arm Type

Experimental

Arm Description

Dose 3

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ASP8825

Other Intervention Name(s)

XP13512

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral

Primary Outcome Measure Information:

Title

The change of the International Restless Legs Syndrome rating scale score

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Investigator-related Clinical Global Impression of Improvement

Time Frame

12 weeks

Title

Patient- related Clinical Global Impression of Improvement

Time Frame

12 weeks

Title

The Pittsburgh sleep quality index

Time Frame

12 weeks

Title

The SF-36 Health Survey

Time Frame

12 weeks

Title

The Restless Legs Syndrome QOL Questionnaire

Time Frame

12 weeks

Title

The Medical Outcomes Study sleep scale

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Central Contact

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Study Chair

Facility Information:

City

Chugoku

Country

Japan

City

Hokkaido

Country

Japan

City

Kansai

Country

Japan

City

Kanto

Country

Japan

City

Kyusyu

Country

Japan

City

Tohoku

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

23121149

Citation

Inoue Y, Hirata K, Uchimura N, Kuroda K, Hattori N, Takeuchi M. Gabapentin enacarbil in Japanese patients with restless legs syndrome: a 12-week, randomized, double-blind, placebo-controlled, parallel-group study. Curr Med Res Opin. 2013 Jan;29(1):13-21. doi: 10.1185/03007995.2012.746217. Epub 2012 Nov 30.

Results Reference

derived

Links:

URL

http://www.clinicaltrials.jp/user/ctrSearch.jsp

Description

Link to Results on JAPIC - enter 140643 in the JapicCTI-RNo. field (Japanese record)

Learn more about this trial

ASP8825 - Study in Patients With Restless Legs Syndrome

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