What side effects are associated with this type of intervention?

Common treatments for Myoclonic Epilepsy include antiepileptic drugs such as valproate, levetiracetam, and topiramate. For treatments similar to Lorcaserin, which is a Serotonin 2C Receptor Agonist, side effects can include headache, dizziness, fatigue, nausea, and dry mouth. Additionally, some patients may experience mood changes, cognitive disturbances, and gastrointestinal issues. It is important to monitor for these side effects and discuss them with a healthcare provider to manage and mitigate any adverse effects effectively.

What prior FDA approvals exist?

FDA-approved treatments for Myoclonic Epilepsy include a variety of antiepileptic drugs (AEDs) such as valproic acid, levetiracetam, and clonazepam. These medications work through different mechanisms to control seizures. While there is limited information on FDA-approved treatments specifically targeting serotonin receptors like Lorcaserin, other AEDs that modulate neurotransmitter activity are commonly used. Fenfluramine, which has shown efficacy in Dravet Syndrome, another form of epilepsy, also acts on serotonin pathways and may offer insights into similar treatment approaches.

What other types of research exist?

Promising alternatives to Lorcaserin for Myoclonic Epilepsy include Fenfluramine, which has shown long-term efficacy in reducing seizure frequency in Dravet Syndrome patients. Additionally, other antiepileptic drugs such as Stiripentol and Cannabidiol (CBD) have also demonstrated effectiveness in managing seizures in similar patient populations.

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Lorcaserin for Epilepsy (MOMENTUM 1 Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for Myoclonic Epilepsy include antiepileptic drugs (AEDs) such as valproate, levetiracetam, and lamotrigine. Valproate works by increasing the levels of gamma-aminobutyric acid (GABA) in the brain, which helps to inhibit neuronal firing and reduce seizure activity. Levetiracetam binds to the synaptic vesicle protein SV2A, modulating neurotransmitter release and reducing hyperexcitability. Lamotrigine stabilizes neuronal membranes by inhibiting voltage-sensitive sodium channels, thereby decreasing the release of excitatory neurotransmitters like glutamate. Understanding these mechanisms is crucial for Myoclonic Epilepsy patients as it helps in selecting the most effective treatment with the least side effects. Lorcaserin, a Serotonin 2C Receptor Agonist, is being studied for its potential to modulate neurotransmitter systems differently, offering a novel approach that could benefit patients who do not respond well to traditional AEDs.

Phase 3

Recruiting

Research Sponsored by Eisai Inc.

Eligibility Criteria Checklist

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

Must have

Has at least 4 convulsive seizures during the 4 weeks of baseline

Diagnosis of epilepsy with Dravet syndrome

Must not have

Use of lorcaserin within 4 weeks before screening, or any history of it being discontinued due to lack of efficacy or adverse reactions

Recent or concomitant use of serotonergic medications or monoamine oxidase inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 14

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether lorcaserin can reduce the number of convulsive seizures in people with Dravet syndrome, a severe type of epilepsy. The goal is to see if lorcaserin works by targeting brain receptors to stabilize brain activity. Lorcaserin is currently in clinical development for the treatment of epilepsy, building on evidence that it can protect against seizures.

Who is the study for?

This trial is for males and females aged 2 years or older with Dravet syndrome, a type of epilepsy. Participants must have had at least 4 convulsive seizures in the last month and be on stable antiepileptic drugs. Those who've used lorcaserin recently, taken fenfluramine within the past two months, are on certain serotonergic medications or MAO inhibitors, or have progressive brain diseases besides Dravet can't join.

What is being tested?

The study aims to see if Lorcaserin helps reduce seizure frequency better than a placebo in those with Dravet syndrome. Patients will receive either Lorcaserin or a placebo alongside their regular antiepileptic medication to compare effectiveness.

What are the potential side effects?

Lorcaserin may cause side effects such as headaches, dizziness, fatigue, nausea, dry mouth and constipation. It might also affect serotonin levels which could lead to mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had at least 4 convulsive seizures in the last 4 weeks.

Select...

I have been diagnosed with epilepsy that is specifically Dravet syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't taken lorcaserin in the last 4 weeks, nor stopped it due to side effects or it not working.

Select...

I am currently taking or have recently taken medications that affect serotonin levels.

Select...

My condition is worsening and it's not Dravet syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 14 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Core Treatment Period (14 Weeks)

Secondary study objectives

Percentage of 50% Responders for Convulsive Seizures in the Core Treatment Period (14 Weeks) Compared to Baseline

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lorcaserin (Core Study and Open-label Extension Phase)Experimental Treatment1 Intervention

Participants will be randomized to receive lorcaserin administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to less than (\<) 20, 20 to \<40, and greater than or equal to (\>=) 40 kilogram (kg) will be 5, 10, and 20 milligram per day (mg/day) respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to \<20, 20 to \<40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin.

Group II: Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)Placebo Group2 Interventions

Participants will be randomized to receive lorcaserin matching placebo administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to \<20, 20 to \<40, and \>=40 kg will be 5, 10, and 20 mg/day respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to \<20, 20 to \<40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lorcaserin

2008

Completed Phase 3

~820

0 / 5Eligibility criteria met

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

The most common treatments for Myoclonic Epilepsy include antiepileptic drugs (AEDs) such as valproate, levetiracetam, and lamotrigine. Valproate works by increasing the levels of gamma-aminobutyric acid (GABA) in the brain, which helps to inhibit neuronal firing and reduce seizure activity. Levetiracetam binds to the synaptic vesicle protein SV2A, modulating neurotransmitter release and reducing hyperexcitability. Lamotrigine stabilizes neuronal membranes by inhibiting voltage-sensitive sodium channels, thereby decreasing the release of excitatory neurotransmitters like glutamate. Understanding these mechanisms is crucial for Myoclonic Epilepsy patients as it helps in selecting the most effective treatment with the least side effects. Lorcaserin, a Serotonin 2C Receptor Agonist, is being studied for its potential to modulate neurotransmitter systems differently, offering a novel approach that could benefit patients who do not respond well to traditional AEDs.

Melatonin treatment of non-epileptic myoclonus in children.