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.
Patients who complete the 12-week daily dosing efficacy and safety study (XP109) will be allowed to enroll in the open-label extension (OLE) study (XP110), thereby providing exposure to HORIZANT for up to 48 weeks. Enrolled patients will take open-label HORIZANT 600 mg tablets once a day at approximately 5 PM with food, beginning at Week 0 of the OLE study up to and including Week 36. After the end of the treatment period, a follow-up visit will be included 14 days (± 3 days) after the last dose of HORIZANT. Patients will visit the clinical site on 6 different occasions, including a follow-up visit 14 days (± 3 days) after the last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
144
HORIZANT 600 mg once daily
Stanford Sleep Medicine Center
Redwood City, California, United States
WITHDRAWNPacific Research Network
San Diego, California, United States
RECRUITINGClinical Global Impression of Improvement (CGI-I) score
assessment at designated timepoints
Time frame: Week 12
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NW FL Clinical Research Group
Gulf Breeze, Florida, United States
WITHDRAWNFlorida Pediatric Research Institute
Winter Park, Florida, United States
RECRUITINGClinical Integrative Research Center of Atlanta, INC
Atlanta, Georgia, United States
WITHDRAWNJosephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States
RECRUITINGDent Neurologic Institute
Amherst, New York, United States
WITHDRAWNMercy Health - Children's Hospital Pulmonary & Sleep Center
Toledo, Ohio, United States
TERMINATEDThe Sleep Center at the Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
WITHDRAWNSleepMed of South Carolina; SleepMed, Inc.
Columbia, South Carolina, United States
RECRUITING...and 1 more locations