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

NCT04050293 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 538P401
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine Disorders; Headache Disorders

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Monthly Migraine Days (MMDs) in Children 6 to 11 Years Old With Migraine.

  The primary efficacy endpoint was the change in rate of the MMDs relative to the Prospective Baseline Period (PBP). The 28-day rate of MMDs was calculated as the ratio of the # days of migraine during the last 4 weeks of PBP and the # days with non-missing headache record in the electronic diary during the last 4 weeks of the 20-week double-blind Treatment Phase, x 28. The primary outcome measure was recorded on 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.

  Baseline, Titration Period 1 (Month 1), Titration Period 2 (Month 2), Maintenance Period 1 (Month 3), Maintenance Period 2 (Month 3), Maintenance Period 2 (Month 4) and Maintenance Period 3 (Month 5)

Study Arms (2)

SPN-538 (Topiramate XR capsule)

EXPERIMENTAL

Participants will be treated with SPN-538

Drug: SPN-538

Placebo

PLACEBO COMPARATOR

Participants will be treated with Placebo

Drug: Placebo

Interventions

Placebo DRUG

Participants will receive Placebo

Placebo

SPN-538 DRUG

Participants will receive SPN-538

SPN-538 (Topiramate XR capsule)

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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, 3-12 migraine episodes and no more than 14 headache days (migraine and non-migraine) per month during the 3 months prior to Screening and during the 28-day Prospective Baseline Period, a PedMIDAS Disability score of ≥20 and ≤139 and weight at least 20 kg and no more than 60 kg.

You may not qualify if:

• Subjects with chronic migraine (\>14 headache days per month), cluster headaches, or migraine aura without headache and who are unable to distinguish migraines from other headache types.
• Subjects with more than 14 headache days during the 28-day Prospective Baseline Period
• Have taken any disallowed migraine preventive medication including TPM within 14 days prior to the start of the Prospective Baseline Period; or used onabotulinumtoxinA (Botox®) within 3 months prior to Screening.
• Failure to respond to topiramate prophylaxis therapy (2 to 3 mg/kg/day) for a minimum of 3 months, or those who have previously discontinued TPM due to AEs within 6 months prior to Screening.
• Failure to more than 2 adequate clinical trials of an established prophylactic antimigraine regimen within 6 months prior to Screening.
• Current use of antipsychotics, antimanics, barbiturates, benzodiazepines amitriptyline, lithium, valproic acid, tricyclic antidepressants, AEDs, calcium channel blockers, sedatives, SSRIs, NSRIs, CGRP receptor antagonists, CBD oil, herbal preparations/supplements such as feverfew or St John's wort and/or any medications that could impair or decrease thinking and concentration.
• 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 \[NSAIDs\]), or use of narcotics.
• Use of non-pharmacologic complementary and alternative prophylactic approaches for migraine prevention, such as neuromodulation, acupuncture, behavioral interventions, spinal manipulation, occipital nerve block and neurofeedback.
• 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 6 months before screening, pregnancy, active liver disease or abnormal kidney function.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (1)

CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

Due to study termination (difficulty in recruitment), the target number of participants needed to achieve statistically reliable results was not met.

Results Point of Contact

• Title: Gianpiera Ceresoli-Borroni Director Clinical Research
• Organization: Supernus Pharmaceuticals

gceresoliborroni@supernus.com

3018382521

Study Officials

• Gianpiera Ceresoli-Borroni, PhD

  Employee of Supernus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, placebo-controlled, 2-arm, parallel group study

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 8, 2019
• Study Start: July 14, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: January 22, 2026
• Results First Posted: November 21, 2025

Record last verified: 2025-12

Locations

US (1)