A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00225862

Collaborator

(none)

140

Enrollment

Locations

Duration (Months)

3.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome	Drug: ropinirole	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A 12-week, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Intermittent Dosing of Ropinirole in Patients With Restless Legs Syndrome (RLS)

Study Start Date :

Jan 1, 2005

Actual Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase. [12 Weeks]

Secondary Outcome Measures

Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication. [12 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Â Inclusion criteria:

Patients diagnosed with Restless Legs Syndrome (RLS).
Patients diagnosed with RLS (symptoms include an overwhelming urge to move legs usually accompanied by uncomfortable sensations in the legs; usually occur at rest; worse during the evening or night and generally relieved, at least temporarily, by movement).
Patients must give written informed consent prior to any specific study procedures.

Exclusion criteria:

Patients with a primary sleep disorder other than RLS.
Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease).
Other inclusion or exclusion criteria to be evaluated by the physician.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Alabaster	Alabama	United States	35007
2	GSK Investigational Site	Jasper	Alabama	United States	35501
3	GSK Investigational Site	Peoria	Arizona	United States	85381 - 4828
4	GSK Investigational Site	Phoenix	Arizona	United States	85032
5	GSK Investigational Site	Northridge	California	United States	91325
6	GSK Investigational Site	Oxnard	California	United States	93030
7	GSK Investigational Site	Redondo Beach	California	United States	90277
8	GSK Investigational Site	Santa Monica	California	United States	90404
9	GSK Investigational Site	Fairfield	Connecticut	United States	06824
10	GSK Investigational Site	Largo	Florida	United States	33773
11	GSK Investigational Site	Pembroke Pines	Florida	United States	33026
12	GSK Investigational Site	St. Petersburg	Florida	United States	33701
13	GSK Investigational Site	Tampa	Florida	United States	33606
14	GSK Investigational Site	Chicago	Illinois	United States	60611
15	GSK Investigational Site	Elk Grove Village	Illinois	United States	60007
16	GSK Investigational Site	Flossmoor	Illinois	United States	60422
17	GSK Investigational Site	Topeka	Kansas	United States	66606
18	GSK Investigational Site	Baton Rouge	Louisiana	United States	70808
19	GSK Investigational Site	Frederick	Maryland	United States	21702
20	GSK Investigational Site	Newton Center	Massachusetts	United States	02459
21	GSK Investigational Site	Newton	Massachusetts	United States	02459
22	GSK Investigational Site	Bingham Farms	Michigan	United States	48025
23	GSK Investigational Site	Edison	New Jersey	United States	08818
24	GSK Investigational Site	Albuquerque	New Mexico	United States	87106
25	GSK Investigational Site	Albuquerque	New Mexico	United States	87108
26	GSK Investigational Site	Amherst	New York	United States	14226
27	GSK Investigational Site	New Hyde Park	New York	United States	11040
28	GSK Investigational Site	Raleigh	North Carolina	United States	27607
29	GSK Investigational Site	Concinnati	Ohio	United States	45219
30	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73112
31	GSK Investigational Site	Lafayette Hill	Pennsylvania	United States	19444
32	GSK Investigational Site	Columbia	South Carolina	United States	29201
33	GSK Investigational Site	Austin	Texas	United States	78756
34	GSK Investigational Site	Plano	Texas	United States	75093
35	GSK Investigational Site	San Antonio	Texas	United States	78229
36	GSK Investigational Site	Walla Walla	Washington	United States	99362
37	GSK Investigational Site	Wenatchee	Washington	United States	98801