HORIZANT 600 mg for Restless Legs Syndrome

Recruiting · < 18 · All Sexes · Indianapolis, IN

This study is evaluating whether a drug called gabapentin can help reduce the symptoms of restless legs syndrome.

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About the trial for Restless Legs Syndrome

Eligible Conditions
RLS · Restless Legs Syndrome

Treatment Groups

This trial involves 2 different treatments. HORIZANT 600 Mg is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.


This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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
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Odds of Eligibility
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Week 12
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 12.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether HORIZANT 600 mg will improve 1 primary outcome in patients with Restless Legs Syndrome. Measurement will happen over the course of Week 12.

Clinical Global Impression of Improvement (CGI-I) score
assessment at designated timepoints

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes restless legs syndrome?

The restless legs syndrome is typically caused by [sympathetic nervous system] stimulation, while no correlation exists between the presence of dopamine in the [nervous system] and the occurrence of restless legs syndrome. The present study highlights the significance of dopamine and sympathetic innervation in the sleep-wake cycle. The absence of dopamine in restless legs syndrome patients indicates an [parasympathetic nervous system] disorder, such as [nervous system] stimulation. Furthermore, the [nervous system] stimulation of restless legs syndrome patients is caused by the presence of dopamine. Patients suffering from restless legs syndrome can be treated using dopamine antagonist medications such as amineptine, pergolide, and ropinirole.

Anonymous Patient Answer

What is restless legs syndrome?

Given the broad spectrum of symptoms and associated behaviors, it is important to recognize RLS, because it can present with similar characteristics and manifestations as some other medical conditions. The diagnosis and treatment of RLS can improve the quality of life and symptom relief of the patient and is critical to the physician's practice.

Anonymous Patient Answer

Can restless legs syndrome be cured?

Restless legs syndrome may be cured with pharmacological and psychological treatments. In most cases however, this effect is small and does not lead to a complete relief from the symptoms.

Anonymous Patient Answer

How many people get restless legs syndrome a year in the United States?

Around 7.1 million American adults have at least one symptom of restless legs syndrome, about as many as have chronic kidney disease. This suggests that there are several undetected cases of restless legs syndrome in the U.S. population.

Anonymous Patient Answer

What are the signs of restless legs syndrome?

Restless legs syndrome can present itself with a variety of clinical signs. Patient report can be unreliable and may not be specific for the diagnosis. A positive iron deficiency test appears to be the most specific finding, and may warrant further investigation. RLS may be an under-diagnosed disorder.

Anonymous Patient Answer

What are common treatments for restless legs syndrome?

In a recent study, findings suggest that RLS can be adequately and sustainably treated with dopaminergic augmentation, although there is limited data available to support the use of dopamine agonists in managing non-compliant patients. The majority of patients treated with duloxetine also experienced subjective improvement; however, there were no statistically significant differences in RLS-specific outcomes between groups. Future investigations examining the efficacy and tolerability of duloxetine and other emerging dopamine-enhancing drugs are warranted.

Anonymous Patient Answer

Is horizant 600 mg typically used in combination with any other treatments?

The use of 600 mg horizant in combination with other treatments was the most common formulation prescribed in all study groups. A higher degree of tolerability was observed for 600 mg horizant than for placebo at all times and was not affected by the type of treatment being added. A larger, prospective, randomized study is needed to confirm these findings. The use of horizant 600 mg as a monotherapy in RLS appears promising, but long-term therapeutic effects requiring combination with other drugs and patients with comorbidities have yet to be adequately explored.

Anonymous Patient Answer

Does restless legs syndrome run in families?

Because the RLS-inherited pattern of inheritance is not the same as that for the RLS phenotype itself, the genetic architecture of RLS appears to be substantially different from that of idiopathic RLS.

Anonymous Patient Answer

How does horizant 600 mg work?

The placebo effect in RLS patients is large as was shown in a large sample meta-analysis: (a) placebo effect has not been adequately controlled in previous studies regarding RLS; (b) the placebo effect may be better controlled in studies of RLS compared to other disorders such as chronic heart failure; and (c) the placebo effect may explain the discrepancy between clinical trials and observational studies in regards to the efficacy of dopaminergic drugs in relieving RLS symptoms.

Anonymous Patient Answer

Have there been other clinical trials involving horizant 600 mg?

Findings from a recent study demonstrated that a single dose of 600 mg Horizant XR was efficacious in relieving the symptoms of restless legs syndrome and that there did not appear to be a need to reinforce the dosage of Horizant XR when symptoms recurred up to 10 hours after dose administration for up to 10 days of continuous treatment.

Anonymous Patient Answer

What is the primary cause of restless legs syndrome?

Restless legs syndrome occurs as an unexpected and temporary symptom in a large part of patients and its cause remains unknown. Restless legs syndrome is a condition that needs comprehensive medical and surgical management to achieve the optimum treatment result and to decrease the risk of recurrence. It is essential to recognize RLS in patients early on as a potentially serious condition and to have a detailed evaluation followed by adequate management.

Anonymous Patient Answer

What are the common side effects of horizant 600 mg?

Symptoms of RLS include: \n- Paresthesias\n- Restless (feeling) legs\n- Restlessness\n- Sleep disruption\n- Excessive sweating\n\nSide effects of horizant are similar to those of placebo. Side effects of horizant are common. Horizant may cause dizziness (dizziness is a side effect of other CNS depressants, and can be a symptom of drug overdoses or withdrawal.) Horizant may also cause hallucinations and delusions.

Anonymous Patient Answer
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