What is the mechanism of action of this treatment?

Gabapentin Enacarbil, a prodrug of Gabapentin, works by modulating the release of excitatory neurotransmitters and reducing neuronal excitability, which helps alleviate the symptoms of Restless Leg Syndrome (RLS). This is crucial for RLS patients as it addresses the underlying hyperexcitability of the nervous system that contributes to the uncomfortable sensations and urge to move the legs. Other common treatments for RLS include dopamine agonists, which stimulate dopamine receptors to improve motor control and reduce symptoms, and opioids, which can help manage severe cases by altering pain perception and providing relief from discomfort. These mechanisms are important as they target different aspects of the disorder, offering a range of therapeutic options to improve patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for Restless Leg Syndrome (RLS) similar to HORIZANT (Gabapentin Enacarbil) include gabapentin and its prodrugs. Known side effects of gabapentin and gabapentin enacarbil include dizziness, somnolence, peripheral edema, and potential weight gain. Some patients may also experience fatigue, dry mouth, and ataxia. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Restless Leg Syndrome (RLS). HORIZANT (Gabapentin Enacarbil) is a prodrug of Gabapentin and is specifically approved for moderate-to-severe primary RLS. Gabapentin itself, although not specifically approved for RLS, is often used off-label due to its ability to modulate excitatory neurotransmitter release and reduce neuronal excitability. Other FDA-approved treatments for RLS include dopamine agonists such as pramipexole and ropinirole, which help alleviate symptoms by stimulating dopamine receptors. Additionally, rotigotine, a dopamine agonist available as a transdermal patch, is also approved for RLS treatment.

What other types of research exist?

Promising novel alternatives to HORIZANT for RLS patients include: 1) Rotigotine transdermal patch, a dopamine agonist that has shown efficacy in improving early morning motor function and sleep in Parkinson's disease, which may translate to benefits in RLS. 2) Sodium oxybate, primarily used for narcolepsy, has shown potential in improving sleep measures and could be considered for RLS pending further safety and efficacy studies. 3) Cannabinoids, such as nabilone, have shown preliminary efficacy for sleep problems in Parkinson's disease and may offer benefits for RLS with more data. These alternatives offer different mechanisms of action and could provide new options for RLS management.

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Gamma-Aminobutyric Acid (GABA) Analog

HORIZANT for Restless Legs Syndrome (RLS Trial)

Phase 4

Waitlist Available

Research Sponsored by XenoPort, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests the safety and effectiveness of HORIZANT in teenagers with severe Restless Legs Syndrome. The medication helps reduce leg discomfort, aiding relaxation and better sleep. HORIZANT has shown improvements in previous studies for moderate to severe restless legs syndrome.

Who is the study for?

This trial is for adolescents aged 13-17 with moderate-to-severe primary Restless Legs Syndrome (RLS) who completed the HORIZANT Study XP109. Participants must not use drugs affecting RLS or sleep, and if sexually active, agree to effective contraception methods. Those with unstable medical conditions or noncompliance risks are excluded.

What is being tested?

The study tests the long-term effectiveness and safety of a daily dose of HORIZANT (Gabapentin Enacarbil) at 600 mg in treating adolescent RLS. It's an extension study focusing on those who've previously taken part in related research.

What are the potential side effects?

While specific side effects for this age group aren't listed here, Gabapentin Enacarbil can generally cause dizziness, sleepiness, headache, nausea, and fatigue among others.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Global Impression of Improvement (CGI-I) score

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815

Allergic reaction

100%

80%

60%

40%

20%

Study treatment Arm

Gabapentin

Benzodiazepine

Awards & Highlights

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HORIZANT 600 mgExperimental Treatment1 Intervention

HORIZANT 600 mg once daily

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Gabapentin Enacarbil, a prodrug of Gabapentin, works by modulating the release of excitatory neurotransmitters and reducing neuronal excitability, which helps alleviate the symptoms of Restless Leg Syndrome (RLS). This is crucial for RLS patients as it addresses the underlying hyperexcitability of the nervous system that contributes to the uncomfortable sensations and urge to move the legs. Other common treatments for RLS include dopamine agonists, which stimulate dopamine receptors to improve motor control and reduce symptoms, and opioids, which can help manage severe cases by altering pain perception and providing relief from discomfort. These mechanisms are important as they target different aspects of the disorder, offering a range of therapeutic options to improve patient outcomes.

Some pharmacological studies on the spastic mouse.Remarkable improvement of primary orthostatic tremor using perampanel.Flumazenil therapy for a gabapentin-induced coma: a case report.