A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
NCT00627003
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- Idiopathic RLS
- Moderate to severe symptoms as indicated by an IRLS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4
- In a baseline polysomnography, patients had to have periodic leg movements during sleep arousal index greater than 5/hour of total sleep time
- Patients suffering from seconadry RLS, due to causes such as iron deficiency or renal
disease, or suffering from secondary RLS while taking drugs suspected of causing
secondary forms of RLS
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Descriptive Information | ||||
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Brief Title ICMJE | A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS | |||
Official Title ICMJE | A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study 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 placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed. | |||
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 | 43 | |||
Original Actual Enrollment ICMJE | 30 | |||
Actual Study Completion Date ICMJE | May 2003 | |||
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 | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00627003 | |||
Other Study ID Numbers ICMJE | CABAS-0067-033 | |||
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 | April 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |