ASP8825

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

474 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-01-31

Brief Summary

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

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Detailed Description

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

Conditions

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Restless Legs Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Dose 1

Group Type EXPERIMENTAL

Intervention Type DRUG

oral

2

Dose 2

Group Type EXPERIMENTAL

ASP8825

Intervention Type DRUG

oral

3

Dose 3

Group Type EXPERIMENTAL

ASP8825

Intervention Type DRUG

oral

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Interventions

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ASP8825

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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XP13512

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No