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Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Primary Purpose

Restless Legs Syndrome

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ASP8825
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who diagnosed with RLS according to the diagnostic criteria established by the International RLS Study Group
  • International Restless Legs Syndrome Scale (IRLS) score ≥15 presence of RLS symptoms on ≥15 days per month and ≥4 days per week preceding inclusion in this study

Exclusion Criteria:

  • Patients using dopamine agonists or gabapentin within 1 week before or any anti-RLS treatment within 2 weeks before the start of the pretreatment observation period
  • Patients with an estimated creatinine clearance <60 mL/min determined using the Cockcroft-Gault formula
  • Pregnant or lactating women
  • Individuals with serum ferritin <20 ng/mL were also excluded from the trial
  • Individuals with movement disorders and/or abnormal neurological findings

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASP8825 group

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in IRLS score
IRLS: International Restless Legs Syndrome Scale
Safety assessed by Vital signs
Blood pressure and pulse rate
Safety assessed by Adverse Events
Safety assessed by Laboratory tests
Hematology, blood biochemistry, thyroid function test and urinalysis
Safety assessed by 12-lead-electrocardiogram

Secondary Outcome Measures

Proportion of responders on ICGl of improvement
ICGI: Investigator-rated Clinical Global Impression of improvement
Proportion of responders on PCGI of improvement
PCGI: Patient-rated Clinical Global Impression
Change from baseline in PSQI
PSQI: Pittsburgh Sleep Quality Index
Change from baseline in SF-36v2
SF-36v2: Medical Outcomes Study 36-Item Short-Form Health Survey version 2
Change from baseline in RLS-QOL
RLS-QOL: Restless Legs Syndrome Quality of Life Questionnaire
Change from baseline in MOS sleep scale
MOS: Medical outcomes study
Plasma concentration of gabapentin

Full Information

First Posted
January 13, 2016
Last Updated
February 3, 2016
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02658188
Brief Title
Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
Official Title
Long-term Study - Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin enacarbil) for long-term treatment of restless legs syndrome patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
Keywords
Restless legs syndrome patients, ASP8825, XP13512

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASP8825 group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ASP8825
Other Intervention Name(s)
gabapentin enacarbil
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Change from baseline in IRLS score
Description
IRLS: International Restless Legs Syndrome Scale
Time Frame
Baseline to Week 52
Title
Safety assessed by Vital signs
Description
Blood pressure and pulse rate
Time Frame
Up to Week 52
Title
Safety assessed by Adverse Events
Time Frame
Up to Week 52
Title
Safety assessed by Laboratory tests
Description
Hematology, blood biochemistry, thyroid function test and urinalysis
Time Frame
Up to Week 52
Title
Safety assessed by 12-lead-electrocardiogram
Time Frame
Up to Week 52
Secondary Outcome Measure Information:
Title
Proportion of responders on ICGl of improvement
Description
ICGI: Investigator-rated Clinical Global Impression of improvement
Time Frame
Up to Week 52
Title
Proportion of responders on PCGI of improvement
Description
PCGI: Patient-rated Clinical Global Impression
Time Frame
Up to Week 52
Title
Change from baseline in PSQI
Description
PSQI: Pittsburgh Sleep Quality Index
Time Frame
Baseline to Week 52
Title
Change from baseline in SF-36v2
Description
SF-36v2: Medical Outcomes Study 36-Item Short-Form Health Survey version 2
Time Frame
Baseline to Week 52
Title
Change from baseline in RLS-QOL
Description
RLS-QOL: Restless Legs Syndrome Quality of Life Questionnaire
Time Frame
Baseline to Week 52
Title
Change from baseline in MOS sleep scale
Description
MOS: Medical outcomes study
Time Frame
Baseline to Week 52
Title
Plasma concentration of gabapentin
Time Frame
Week 12, 28 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who diagnosed with RLS according to the diagnostic criteria established by the International RLS Study Group International Restless Legs Syndrome Scale (IRLS) score ≥15 presence of RLS symptoms on ≥15 days per month and ≥4 days per week preceding inclusion in this study Exclusion Criteria: Patients using dopamine agonists or gabapentin within 1 week before or any anti-RLS treatment within 2 weeks before the start of the pretreatment observation period Patients with an estimated creatinine clearance <60 mL/min determined using the Cockcroft-Gault formula Pregnant or lactating women Individuals with serum ferritin <20 ng/mL were also excluded from the trial Individuals with movement disorders and/or abnormal neurological findings
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Chiba
Country
Japan
City
Fukuoka
Country
Japan
City
Hokkaido
Country
Japan
City
Hyogo
Country
Japan
City
Kanagawa
Country
Japan
City
Kyoto
Country
Japan
City
Miyagi
Country
Japan
City
Osaka
Country
Japan
City
Saitama
Country
Japan
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=8825-CL-0005
Description
Link to results on Astellas Clinical Study Results Web site

Learn more about this trial

Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

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