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HORIZANT for Restless Legs Syndrome (RLS Trial)
RLS Trial Summary
This trial is testing if a medication called HORIZANT is safe and effective for treating Restless Legs Syndrome in adolescents.
RLS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 4 trial • 88 Patients • NCT03012815RLS Trial Design
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- I am willing to avoid drugs that could impact sleep or restless leg syndrome studies.I am willing to avoid drugs that could impact sleep or leg movement assessments.I agree to use contraception if I can father a child, starting 30 days before and during the study.I do not have any unstable health conditions that would make me unsuitable for a study with gabapentin enacarbil.
- Group 1: HORIZANT 600 mg
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What adverse effects could arise from ingesting HORIZANT 600 mg?
"With the drug having already been authorised for use, HORIZANT 600 mg's safety level is graded as a 3 on our scale. This evaluation comes from its being in Phase 4 of clinical trials."
Is this medical trial unprecedented in its scope and methodology?
"Since 2016, HORIZANT 600 mg has been a subject of medical research. The initial trial in that year was sponsored by XenoPort Inc., and the subsequent Phase 4 drug approval occurred after 144 patients participated successfully. In total, there are presently 3 ongoing studies related to this medication across 14 urban centres within one nation."
How many medical facilities in this state are administering the trial?
"Presently, potential participants can choose to enroll at 4 different medical sites - Indianapolis, San Diego and Winter Park being the most prominent. It is recommended that patients pick the location closest to them in order to reduce any travel-related stressors."
How many volunteers have registered for this experiment?
"Affirmative. Per the information procured from clinicaltrials.gov, this medical trial is currently taking applications. It was initially posted on January 1st 2016 and recently modified on June 7th 2021; for it to be successful 144 participants must be accepted across 4 different sites."
To what extent must an individual meet certain criteria to partake in this trial?
"This medical trial is seeking 144 individuals aged 13 to 17 who have restless leg syndrome and are willing to abstain from any substances that could impact the result of their assessment. Additionally, before partaking in study procedures, both patient and guardian must sign IRB-approved assent and consent forms."
Are there any vacancies in this medical trial for prospective participants?
"Yes, the data available on clinicaltrials.gov confirms that this study is presently accepting participants. It was first made public on January 1st 2016 with a most recent update occurring on June 7th 2021. The trial aims to enrol 144 patients from 4 separate sites."
Is enrollment open to participants older than 45 years of age?
"The parameters for patient eligibility are between 13 and 17 years old, in compliance with the study's stated inclusion criteria."
Has the efficacy of HORIZANT 600 mg been explored in other studies?
"The first HORIZANT 600 mg study was conducted in 2016 by the Stanford Sleep Medicine Centre. Since then, 26 trials have completed and 3 are ongoing - all of which utilise Indianapolis, Indiana as their primary location."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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