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An extension study to evaluate the efficacy and safety of horizant in adolescents with moderate-to-severe primary RLS

Sponsored by XenoPort, Inc.

Phase Quota
Phase 4

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

Specialties: Internal Medicine: Adol/Youth Medicine Family Medicine: Adol/Youth Medicine

Interventions

  • Drug: HORIZANT 600 mg

Inclusion criteria

  • 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

Exclusion criteria

  • 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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