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

Restless Legs Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658188
• Other study ID #: 8825-CL-0005
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2016
• Last updated: February 3, 2016
• Start date: December 2007
• Est. completion date: April 2009

Study information

• Verified date: February 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• ASP8825
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in IRLS score	IRLS: International Restless Legs Syndrome Scale	Baseline to Week 52	No
Primary	Safety assessed by Vital signs	Blood pressure and pulse rate	Up to Week 52	No
Primary	Safety assessed by Adverse Events		Up to Week 52	No
Primary	Safety assessed by Laboratory tests	Hematology, blood biochemistry, thyroid function test and urinalysis	Up to Week 52	No
Primary	Safety assessed by 12-lead-electrocardiogram		Up to Week 52	No
Secondary	Proportion of responders on ICGl of improvement	ICGI: Investigator-rated Clinical Global Impression of improvement	Up to Week 52	No
Secondary	Proportion of responders on PCGI of improvement	PCGI: Patient-rated Clinical Global Impression	Up to Week 52	No
Secondary	Change from baseline in PSQI	PSQI: Pittsburgh Sleep Quality Index	Baseline to Week 52	No
Secondary	Change from baseline in SF-36v2	SF-36v2: Medical Outcomes Study 36-Item Short-Form Health Survey version 2	Baseline to Week 52	No
Secondary	Change from baseline in RLS-QOL	RLS-QOL: Restless Legs Syndrome Quality of Life Questionnaire	Baseline to Week 52	No
Secondary	Change from baseline in MOS sleep scale	MOS: Medical outcomes study	Baseline to Week 52	No
Secondary	Plasma concentration of gabapentin		Week 12, 28 and 52	No

External Links

•   Link to results on Astellas Clinical Study Results Web site