A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS
NCT00625547
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Diagnosis of idiopathic RLS and had all 4 clinical manifestations of RLS
- Moderate to severe symptoms of RLS as indicated by an IRLSSG-RS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 on an 11-point RLS-6 rating scale
- No previous treatment for RLS or dissatisfaction with their current therapy
- Not available
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Innsbruck,
- Wien,
- Altoetting,
- Aschaffenburg,
- Bad Honnef,
- Bad Saarow,
- Beckum,
- Berlin,
- Berlin,
- Berlin,
- Berlin,
- Berlin,
- Bochum,
- Bremerhaven,
- Dillingen,
- Duesseldorf,
- Duisburg,
- Gelsenkirchen,
- Gera,
- Goettingen,
- Goettingen,
- Halle,
- Hamburg,
- Heilbronn,
- Jena,
- Kaiserslautern,
- Karlsruhe,
- Karlsruhe,
- Kassel,
- Köthen,
- Marburg,
- Mittweida,
- Moenchengladbach,
- Neubrandenburg,
- Oldenburg,
- Quickborn,
- Regensburg,
- Schwalmstadt,
- Schwerin,
- Stuttgart,
- Tuttlingen,
- Ulm,
- Wiesbaden,
- Wolfsburg,
- Goteborg,
- Karlstad,
- Linköping,
- Basel,
- Bern,
- Zürich,
- Tuscaloosa, Alabama
- Little Rock, Arkansas
- San Diego, California
- Santa Monica, California
- Aurora, Colorado
- Brandon, Florida
- Macon, Georgia
- Louisville, Kentucky
- Baton Rouge, Louisiana
- Raleigh, North Carolina
- Salisbury, North Carolina
- Winston-Salem, North Carolina
- Oklahoma City, Oklahoma
- Dallas, Texas
- Alexandria, Virginia
- Innsbruck,
- Vienna,
- Bad Saarow,
- Berlin,
- Goettingen,
- Mittweida,
- Muenchen,
- Oldenburg,
- Schwerin,
- Madrid,
- Jasper, Alabama
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Little Rock, Arkansas
- Burlingame, California
- Pasadena, California
- Redlands, California
- San Diego, California
- San Diego, California
- Santa Ana, California
- Santa Monica, California
- Aurora, Colorado
- Hallandale Beach, Florida
- Miami, Florida
- Pembroke Pines, Florida
- Spring Hill, Florida
- Atlanta, Georgia
- Macon, Georgia
- Overland Park, Kansas
- Crestview Hills, Kentucky
- Lexington, Kentucky
- Baton Rouge, Louisiana
- Chevy Chase, Maryland
- Brighton, Massachusetts
- Kalamazoo, Michigan
- Portage, Michigan
- New York, New York
- Hickory, North Carolina
- Raleigh, North Carolina
- Winston Salem, North Carolina
- Winston-Salem, North Carolina
- Cincinnati, Ohio
- Dublin, Ohio
- Middleburg Heights, Ohio
- Oklahoma City, Oklahoma
- Clarks Summit, Pennsylvania
- Lafayette Hill, Pennsylvania
- Columbia, South Carolina
- Austin, Texas
- Austin, Texas
- Dallas, Texas
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS | |||
Official Title ICMJE | A Double-Blind, Randomized, Active-Controlled Multicenter Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS) | |||
Brief Summary | The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Treatment | |||
Condition ICMJE | Restless Legs Syndrome | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 361 | |||
Original Actual Enrollment ICMJE | 340 | |||
Actual Study Completion Date ICMJE | December 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Germany, Sweden, Switzerland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00625547 | |||
Other Study ID Numbers ICMJE | CABAS-0067-031 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | October 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |