Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
Long-term Study - Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
1 other identifier
interventional
182
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2007
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
January 18, 2016
CompletedFebruary 4, 2016
February 1, 2016
1.3 years
January 13, 2016
February 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change from baseline in IRLS score
IRLS: International Restless Legs Syndrome Scale
Baseline to Week 52
Safety assessed by Vital signs
Blood pressure and pulse rate
Up to Week 52
Safety assessed by Adverse Events
Up to Week 52
Safety assessed by Laboratory tests
Hematology, blood biochemistry, thyroid function test and urinalysis
Up to Week 52
Safety assessed by 12-lead-electrocardiogram
Up to Week 52
Secondary Outcomes (7)
Proportion of responders on ICGl of improvement
Up to Week 52
Proportion of responders on PCGI of improvement
Up to Week 52
Change from baseline in PSQI
Baseline to Week 52
Change from baseline in SF-36v2
Baseline to Week 52
Change from baseline in RLS-QOL
Baseline to Week 52
- +2 more secondary outcomes
Study Arms (1)
ASP8825 group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients who diagnosed with RLS according to the diagnostic criteria established by the International RLS Study Group
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Chiba, Japan
Unknown Facility
Fukuoka, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Hyōgo, Japan
Unknown Facility
Kanagawa, Japan
Unknown Facility
Kyoto, Japan
Unknown Facility
Miyagi, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Saitama, Japan
Unknown Facility
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2016
First Posted
January 18, 2016
Study Start
December 1, 2007
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
February 4, 2016
Record last verified: 2016-02