Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-24 @ 7:03 PM
NCT ID:
NCT02633657
Brief Summary:
The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe Primary Restless Legs Syndrome (RLS).
Detailed Description:
One-treatment, 1-period study in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS. Patients will check-in at the clinical site in the evening of Day -1 or the morning of Day 0, and baseline safety assessments will be performed. On Day 0, after the review of these safety assessments and confirmation of eligibility, patients will receive a single oral 300 mg dose of HORIZANT with a meal (at approximately 6 AM). Study assessments will continue until approximately 14 hours (h) post dose, at which time patients will be discharged. Prior to discharge, patients will be advised not to drive a car or operate other complex machinery for at least 30 h after dosing; therefore, patients can remain at the clinical site overnight or can be escorted home. Patients will return to the clinical site for a follow-up visit 7 days (± 1 day) post dose.
Study:
NCT02633657
Study Brief:
Protocol Section:
NCT02633657