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HORIZANT 300 mg for Restless Leg Syndrome (RLS Trial)
RLS Trial Summary
This trial is testing if two different doses of a drug are effective at treating restless leg 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.RLS Trial Design
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Who is running the clinical trial?
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- You are a teenager between the ages of 13 and 17 and have been diagnosed with Restless Legs Syndrome (RLS) according to specific guidelines.You have a sleep disorder that is not Restless Leg Syndrome (RLS) and could greatly impact the symptoms of RLS.You have a history of thinking about or attempting suicide, as assessed by a questionnaire at the screening appointment, and as determined by the doctor's judgment.You have had an allergic reaction, bad sensitivity, or intolerance to HORIZANT or any other medications containing gabapentin.You have periodic limb movement disorder without restless leg syndrome.You have Restless Leg Syndrome (RLS) symptoms on at least 4 out of 7 nights during the screening period.You have a history of epilepsy or have had a seizure in the past 5 years.
- Group 1: HORIZANT 300 mg
- Group 2: HORIZANT 600 mg
- Group 3: Placebo
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Is enrollment still available for this research trial?
"Affirmative. The clinicaltrials.gov registry demonstrates that this trial, which was posted on February 1st 2016 and modified lastly on June 7th 2021, is actively recruiting participants. 132 individuals are being sought to be enrolled from 4 different research sites."
Could you elucidate on the existing research involving HORIZANT 300 mg?
"Research into the effects of HORIZANT 300 mg began at Stanford Sleep Medicine Center in 2016, and to date there have been 18349 trials completed. At present, 3 clinical studies are ongoing; primarily out of Winter Park, Florida."
Is this an unprecedented research endeavor?
"Research on HORIZANT 300 mg began in 2016, with a primary clinical trial sponsored by XenoPort, Inc. and involving 144 participants. After the initial trial proved successful, further Phase 4 drug approval was granted and 3 ongoing studies across 14 cities are now taking place."
How many healthcare facilities are investigating the efficacy of this trial?
"This clinical trial is presently running in 4 different localities; Winter Park, Saint Louis and Columbia being a few of the identifiable cities. To reduce travel time, it's best to select enrolment at the closest location."
What primary goals is this medical experiment aiming to achieve?
"To assess the efficacy of this trial, researchers will monitor changes to patients' IRLS rating scale over a 12 week period. Additionally, secondary objectives include tracking alterations in IRLS total score, CGI-I scores at Weeks 4 and 8, and proportions of patient sleep parameters measured through Post-Sleep questionnaires at baseline and Week 12."
What eligibility criteria must be met to participate in this trial?
"This clinical investigation is enrolling 132 minors aged 13 to 17, who are suffering from RLS. To be considered eligible, participants must weigh 33.4 kg or more and have a healthy BMI within the 5th-95th percentile range at both screening and baseline visits, demonstrate moderate symptoms of RLS for 4 out of 7 days during the screening period with an IRLS rating scale score above 15, possess sufficient cognitive/communication skills needed to complete study assessments as judged by a clinician."
Are persons of advanced age excluded from this research trial?
"According to the criteria stipulated by this trial, those eligible for participation must be between 13 and 17 years of age. Additionally, there are 4 seperate studies open to minors and one dedicated exclusively to seniors above 65."
How many participants have been included in this exploration?
"Affirmative. The information available on clinicaltrials.gov confirms that this research endeavour, which was initially made public on February 1st 2016, is actively seeking volunteers for participation. In total, 132 individuals are needed to be sourced from 4 different healthcare facilities."
What adverse effects have been observed in individuals taking HORIZANT 300 mg?
"There is an abundance of evidence to support the safety profile of HORIZANT 300mg, hence it has been awarded a score of 3."
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