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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Migraine Disorders, Headache Disorders

In brief

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.

Key facts

Study ID

NCT04050293

Run by

Supernus Pharmaceuticals, Inc.

People needed

26

Starts

2020-07-14

Expected to finish

2023-03-01

Last updated by the study team

2026-01-22

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• CNS Healthcare — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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