What side effects are associated with this type of intervention?

Common treatments for partial seizures, such as carbamazepine, phenytoin, lamotrigine, and levetiracetam, have a range of side effects. Carbamazepine can cause dizziness, drowsiness, nausea, and potential cardiac issues like bradycardia. Phenytoin may lead to gingival hyperplasia, hirsutism, and coordination problems. Lamotrigine is associated with skin rashes, dizziness, and headaches. Levetiracetam's side effects include fatigue, irritability, and dizziness. These medications are generally effective but require monitoring for these potential adverse effects.

What prior FDA approvals exist?

Several anti-seizure medications have been approved by the FDA for the treatment of partial seizures. These include lamotrigine, levetiracetam, oxcarbazepine, and lacosamide. Lamotrigine and levetiracetam are commonly used due to their efficacy and tolerability. Oxcarbazepine is another option that has shown effectiveness in clinical trials. Lacosamide, a newer medication, has also been approved for partial seizures and is known for its favorable safety profile. These medications are similar to EQU-001, which is currently being studied for its efficacy and safety in treating focal onset seizures.

What other types of research exist?

Promising novel alternatives to EQU-001 for partial seizures include: 1. Fenfluramine (Fintepla) - Shown to reduce seizure frequency in Dravet syndrome and may be effective for other types of epilepsy. 2. Cannabidiol (CBD) - Demonstrated efficacy in treatment-resistant epilepsy, including Dravet syndrome. 3. Perampanel - An adjunctive treatment for refractory partial-onset seizures, with long-term safety and efficacy data. 4. Ganaxolone - Currently being studied for various epilepsy syndromes, including CDKL5 deficiency disorder, with promising results.

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EQU-001 for Focal Onset Seizures

Phase 2

Waitlist Available

Research Sponsored by Equilibre Biopharmaceuticals B.V.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 4 weeks from week 5 up to week 16

Summary

This trial tests EQU-001, a new medication, in adults aged 18-65 with epilepsy who have uncontrolled focal onset seizures. It aims to see if EQU-001 can better control seizures when added to their current treatments.

Who is the study for?

Adults aged 18-65 with uncontrolled focal onset seizures, currently on 1-3 anti-seizure medications (ASMs), may join this trial. They must have had a stable dose for at least 4 weeks and not be part of another drug study. Women should use birth control, and participants need to keep a seizure diary. Those with certain neurological conditions, recent substance abuse, or specific medication history are excluded.

What is being tested?

The trial is testing EQU-001's effectiveness in reducing seizures when added to current ASM treatment compared to a placebo. Participants will receive either EQU-001 (20 mg or 60 mg) or placebo during a four-week activation period followed by twelve weeks of maintenance.

What are the potential side effects?

While the side effects for EQU-001 aren't specified here, common side effects from similar epilepsy treatments can include dizziness, fatigue, nausea, and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 4 weeks from week 5 up to week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 4 weeks from week 5 up to week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 weeks from week 5 up to week 16 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Epilepsy

Change in Columbia-Suicide Severity Rating Scale (C-SSRS)

Difference in PGI-C Scale: Patient's Global Impression of Change (PGIC)

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: EQU-001 60 mgExperimental Treatment1 Intervention

EQU-001 60 mg (3 x 20 mg pills)

Group II: EQU-001 20 mgExperimental Treatment2 Interventions

EQU-001 20 mg (1 x 20 mg pill + 2 x matching placebo pills)

Group III: EQU-001 0 mgPlacebo Group1 Intervention

EQU-001 0 mg (3 x matching placebo pills)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EQU-001

2021

Completed Phase 1

~90

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

Common treatments for partial seizures, such as those being studied in the EQU-001 trial, typically work by modulating neuronal excitability to prevent seizure activity. These anti-seizure medications (ASMs) enhance inhibitory neurotransmission (e.g., GABAergic activity), reduce excitatory neurotransmission (e.g., glutamate activity), and stabilize neuronal membranes by modulating ion channels (e.g., sodium and calcium channels). Understanding these mechanisms is crucial for partial seizure patients as it helps in selecting the most effective treatment with the least side effects, thereby improving seizure control and quality of life.

[How do antiepileptic drugs work?].