ASP8825 - Study in Patients With Restless Legs Syndrome

Astellas

Status and phase: Completed; Phase 2

Conditions: Restless Legs Syndrome

Treatments: Drug: ASP8825; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00530530

8825-CL-0003

Details and patient eligibility

About

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

Full description

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

Enrollment: 474 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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474 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Dose 1

Treatment:

Drug: ASP8825

2

Experimental group

Description:

Dose 2

Treatment:

Drug: ASP8825

3

Experimental group

Description:

Dose 3

Treatment:

Drug: ASP8825

4

Placebo Comparator group

Treatment:

Drug: Placebo