Status and phase
Conditions
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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients who completed participation in HORIZANT Study XP109.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
144 participants in 1 patient group
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Central trial contact
Camilla Alexander
Data sourced from clinicaltrials.gov
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