What side effects are associated with this type of intervention?

Common treatments for migraine prophylaxis include anticonvulsants like topiramate and valproate, beta-blockers, and tricyclic antidepressants. Topiramate can cause side effects such as paresthesia, fatigue, anorexia, weight loss, memory difficulties, and taste perversion. Valproate may lead to nausea, somnolence, tremor, dizziness, weight gain, and hair loss, and is contraindicated in pregnancy due to teratogenicity. Gabapentin, although used, has not shown significant efficacy and can cause dizziness and somnolence. Beta-blockers like propranolol may cause fatigue, depression, and hypotension, while tricyclic antidepressants can lead to dry mouth, constipation, weight gain, and orthostatic hypotension.

What prior FDA approvals exist?

The FDA has approved several drugs for the prophylactic treatment of migraines. These include propranolol, a beta-blocker, and onabotulinumtoxinA (Botox), which has shown efficacy in reducing the frequency of chronic migraines. Anticonvulsants like topiramate and valproate have also been approved for migraine prevention. Additionally, tricyclic antidepressants such as amitriptyline are used off-label for migraine prophylaxis. These treatments aim to reduce the frequency and severity of migraine attacks, similar to the goals of the SPN-538 trial.

What other types of research exist?

Promising novel alternatives to SPN-538 for migraine prophylaxis in 2024 include onabotulinumtoxinA, exogenous ketone bodies (βHB salts), and CGRP antagonists. These treatments have demonstrated efficacy in clinical trials and offer new options for migraine prevention.

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SPN-538 for Migraine Prevention in Children

Phase 4

Waitlist Available

Research Sponsored by Supernus Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

Healthy male or female (6 to 11 years of age at the time of screening) with a history of migraine with or without aura for at least 6 months prior to screening

3 to 14 headache days (migraine and non-migraine) per month during the 3 months prior to screening and during Baseline Period

Must not have

Subjects with seizures or a history of seizure-like events

Known history of visual field defects, neurological disorder or structural disorder of the brain from birth; head trauma or previous CNS surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing SPN-538, a medication, to see if it can prevent migraines in children aged 6 to 11. The goal is to reduce how often these children get migraines by stabilizing brain activity.

Who is the study for?

This trial is for children aged 6-11 with a history of migraines, experiencing 3 to 14 headache days per month. They should have a moderate impact on daily activities due to migraines but not suffer from chronic migraine or use certain migraine medications recently. Kids with psychiatric disorders, developmental delays, seizures, brain disorders, suicidal thoughts, pregnancy, or liver/kidney issues can't join.

What is being tested?

The study tests SPN-538 against a placebo to prevent migraines in kids. It aims to see if SPN-538 reduces the number of headache days and improves life quality compared to no treatment (placebo). Participants are randomly assigned either the real medicine or placebo without knowing which one they receive.

What are the potential side effects?

While specific side effects for SPN-538 aren't listed here, common ones for migraine prevention drugs include nausea, fatigue, dry mouth and dizziness. Some may experience more serious effects like allergic reactions or mood changes.

Eligibility Criteria

Inclusion Criteria

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

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I am a healthy child aged 6-11 with a history of migraines for at least 6 months.

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I've had 3 to 14 headache days a month for the last 3 months.

Exclusion Criteria

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

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I have had seizures or events similar to seizures.

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I have a history of brain disorders, surgery, or serious head injury.

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I do not have suicidal thoughts, am not pregnant, and my liver and kidneys are functioning normally.

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I experience more than 14 headache days per month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Frequency of migraine attack per 28 days during the Treatment Phase.

Awards & Highlights

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.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SPN-538Experimental Treatment1 Intervention

Patients will be treated with SPN-538 as a single dose once a day

Group II: PlaceboPlacebo Group1 Intervention

Patients will be treated with Placebo once a day

0 / 6Eligibility 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

Common treatments for migraine work through various mechanisms to alleviate symptoms and prevent attacks. NSAIDs, such as ibuprofen and naproxen, reduce inflammation and pain by inhibiting cyclooxygenase enzymes. Triptans, like sumatriptan and zolmitriptan, activate serotonin receptors (5-HT1B/1D) to constrict blood vessels and inhibit pain pathways. Anticonvulsants, such as topiramate, stabilize neural activity by modulating ion channels and neurotransmitter release. Understanding these mechanisms is crucial for migraine patients as it helps tailor treatments to individual needs, improving efficacy and reducing the frequency and severity of migraine attacks.