ASP8825 - Study in Patients With Restless Legs Syndrome

Restless Legs Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530530
• Other study ID #: 8825-CL-0003
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2007
• Last updated: October 28, 2014
• Start date: September 2007
• Est. completion date: January 2009

Study information

• Verified date: October 2014
• 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

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• ASP8825
oral
• Placebo
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	The change of the International Restless Legs Syndrome rating scale score		12 weeks	No
Secondary	Investigator-related Clinical Global Impression of Improvement		12 weeks	No
Secondary	Patient- related Clinical Global Impression of Improvement		12 weeks	No
Secondary	The Pittsburgh sleep quality index		12 weeks	No
Secondary	The SF-36 Health Survey		12 weeks	No
Secondary	The Restless Legs Syndrome QOL Questionnaire		12 weeks	No
Secondary	The Medical Outcomes Study sleep scale		12 weeks	No

External Links

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