Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
NCT00676403
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- Moderate to severe idiopathic RLS
- symptoms occur predominantly in the evening
- symptoms interfere with sleep onset or maintenance
- Any secondary RLS
- require treatment for daytime RLS symptoms
- symptomatic neuropathies
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients | |||
Official Title ICMJE | Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome | |||
Brief Summary | To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Restless Legs Syndrome | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Allen R, Chen C, Soaita A, Wohlberg C, Knapp L, Peterson BT, García-Borreguero D, Miceli J. A randomized, double-blind, 6-week, dose-ranging study of pregabalin in patients with restless legs syndrome. Sleep Med. 2010 Jun;11(6):512-9. doi: 10.1016/j.sleep.2010.03.003. Epub 2010 May 13. | |||
* 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 | 137 | |||
Original Estimated Enrollment ICMJE | 120 | |||
Actual Study Completion Date ICMJE | January 2009 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 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, Spain, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00676403 | |||
Other Study ID Numbers ICMJE | A0081183 | |||
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 | June 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |