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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine Disorders; Headache Disorders
• Intervention / Treatment: Drug: SPN-538; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gianpiera Ceresoli-Borroni, PhD; Phone Number: 301-838-2521; Email: gceresoliborroni@supenus.com
• Study Contact Backup: Name: Azmi Nasser, PhD; Phone Number: 240-403-5303; Email: anasser@supernus.com

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Recruiting
      • CNS Healthcare
      • Contact: Linda Byrd; Email: lbyrd@cnshealthcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Supernus Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Migraine Disorders; Headache; Headache Disorders
• Other Study ID Numbers: 538P401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No