A Clinical Research Study Testing Ropinirole Treatment fo... | NCT00363857

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

May 2004Actual

Completion Date

May 2004Actual

First Submitted Date

Aug 11, 2006

First Submission Date that Met QC Criteria

Aug 11, 2006

First Posted Date

Aug 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2016

Last Update Posted Date

Oct 17, 2016Estimated

Description Module

Brief Summary

A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360Actual

Name	Type	Description	Arm Group Labels	Other Names
Ropinirole	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in RLS severity rating scale at Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or "creepy-crawly" sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms.
Patients must give written informed consent prior to any specific study procedures.

Exclusion criteria:

Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder.
Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy.
Patients suffering from other movement disorders (i.e. Parkinson's Disease).
Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome.
Participation in any clinical drug or device trial in the last three months.

Other inclusion or exclusion criteria to be evaluated by the physician.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Alabaster	Alabama	35007	United States
GSK Investigational Site

References Module

Citations

Not provided

ID	Term
D012148	Restless Legs Syndrome
D005221	Fatigue
D012893	Sleep Wake Disorders

ID	Term
D009422	Nervous System Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D020447	Parasomnias
D001523	Mental Disorders
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations