Status:
COMPLETED
XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
Lead Sponsor:
XenoPort, Inc.
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).
Detailed Description
This was a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of XP13512 in subjects with Restless Legs Syndrome (RLS). Eligible...
Eligibility Criteria
Inclusion
- Patients with primary RLS, based on the International RLS Study Diagnostic Criteria.
Exclusion
- A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
- Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
- Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
- Pregnant or lactating women;
- Women of childbearing potential who are not practicing an acceptable method of birth control.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT00365352
Start Date
August 1 2006
End Date
December 1 2007
Last Update
July 22 2013
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