An extension study to evaluate the efficacy and safety of horizant in adolescents with moderate-to-severe primary RLS
Sponsored by XenoPort, Inc.
The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS.
Study Start Date: January 2016
Estimated Completion Date: July 2024
Internal Medicine: Adol/Youth Medicine Family Medicine: Adol/Youth Medicine
Drug: HORIZANT 600 mg
Patients who completed participation in 1 of the 2 preceding studies with HORIZANT, Study XP108 or Study XP109
Negative pregnancy test for females of childbearing potential. Male patients able to father a child must agree to use a barrier method (male condom, female condom, diaphragm, or cervical cap) with spermicide for at least 30 days prior to dosing and throughout the study. Fertile, sexually active patients must agree to use 2 medically accepted methods of contraception
Patients must be willing to refrain from using any drugs that are likely to affect RLS or sleep assessments for the duration of the study
Signed patient and parent (or legal guardian) Institutional Review Board (IRB)-approved assent and consent forms before any study procedures are carried out
Patients who, in the opinion of the investigator, would be noncompliant with the study visit schedule, procedures, or medication administration
Patients who have developed clinically significant or unstable medical conditions, or who would otherwise be unsuitable for participation in a continuation study with gabapentin enacarbil
Study Locations And Contact Information
Xenoport Investigational Site, Redwood City California
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