Therapy for Migraine Prevention in Children 6-11 Years of Age

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effect of SPN-538 for the prophylaxis of migraine in pediatric patients 6 to 11 years old.

Detailed Description
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The study is to assess the efficacy and safety of SPN-538 in reducing the monthly migraine headache frequency in pediatric patients with migraine. SPN-538 (or matching placebo) will be administered in patients diagnosed with migraine with or without aura based on the International Headache Society criteria. The frequency of the migraine attack will be assessed as the primary outcome measure.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of SPN-538 as a Therapy for the Prevention of Migraine in Subjects Ages 6-11 Years

Conditions
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Migraine Disorders, Headache Disorders

Intervention / Treatment
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* Drug: SPN-538
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Otherwise, 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, and a PedMIDAS Disability score of > 10 and < 50. Exclusion Criteria: Subjects with chronic migraine (>14 headache days per month), cluster headaches, or migraine aura without headache and, with > 14 headache days during the Baseline Period. Use of migraine preventive medication other than topiramate within 14 days prior to the start of the Baseline Period; or used onabotulinumtoxinA (Botox®) 3 months prior screening and non-pharmacologic complementary and alternative prophylactic approaches for migraine prevention. Failure to respond to topiramate prophylaxis therapy (2 to 3 mg/kg/day) for a minimum of 3 months, or to more than 2 clinical trials with an established prophylactic anti-migraine regimen. Current use or history of antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, β-blockers, tricyclic antidepressants, AEDs, calcium channel blockers, corticosteroids (i.e., systemic, inhaled or topical), daily NSAIDs, sedatives, serotonin selective reuptake inhibitors (SSRIs), non-selective reuptake inhibitors (NSRIs), high-dose magnesium supplements (≥600 mg/day), high-dose riboflavin (≥100 mg/day), calcitonin gene-regulated peptide (CGRP) receptor antagonists, omega-3, melatonin or cannabidiol (CBD) oil. Overuse of analgesic or migraine-specific agents for acute treatment of migraine (>10 treatment days/month of ergot-containing medications or triptans; or >15 treatment days/month with simple analgesics (including non steroidal anti-inflammatory drugs [NSAIDs]) Diagnosis of psychiatric disorder (e.g., psychosis, bipolar disorder, major depression, generalized anxiety disorders), or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation). 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. Evidence of active suicidal ideation and/or suicidal behaviors, pregnancy, active liver disease or abnormal kidney function.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind, randomized, placebo-controlled, 2-arm, parallel group study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPN-538<br>Patients will be treated with SPN-538 as a single dose once a day | Drug: SPN-538<br>* Patients will receive SPN-538<br>|
| Placebo Comparator: Placebo<br>Patients will be treated with Placebo once a day | Drug: Placebo<br>* Patients will receive Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of migraine attack per 28 days during the Treatment Phase. | The primary outcome measure will be recorded daily on an headache electronic diary uploaded on a Patient Reported Outcome (ePRO) application. The electronic diary will serve as the primary tool to collect daily headaches information. | 28 days |