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

538P401

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.

2020-07-14

2024-12-31

2024-12-31

Recruiting

Early phase I

162

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.

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2024-04-24