A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS

Inclusion Criteria

• •1. Male and female adolescent patients, aged 13 to 17 years, diagnosed with RLS based on the IRLSSG consensus criteria, which is presented in Appendix 2.
• •2. Total RLS severity score of 15 or greater on the IRLS rating scale at screening.
• •3. Body weight greater than 33.4 kg and a healthy weight using age-based body mass index (BMI) range 5th to 85th percentile. Appendix 3 contains BMI-for-age charts that can be consulted.
• •4. Negative pregnancy test for females of childbearing potential. Female patients of childbearing potential must agree to use one of the following acceptable birth control methods:
• •1. intrauterine device in place for at least 3 months prior to dosing
• •2. barrier methods (male condom, female condom, diaphragm or cervical cap) with spermicide for at least 30 days prior to dosing and throughout the study
• •3. stable hormonal contraceptive (including oral, injection, or implants) for at least 3 months prior to dosing and throughout the study Female patients who normally abstain from sexual activity may be recruited providing they remain abstinent during the study, or if they become sexually active, they must agree to use effective methods of birth control as described above.
• •5. 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. Male patients who normally abstain from sexual activity may be recruited providing they remain abstinent during the study, or if they become sexually active, they must agree to use a barrier method as described above.
• •6. Signed patient/parent Institutional Review Board (IRB)-approved informed consent/assent form (as applicable) prior to any study procedures.