Status:
TERMINATED
Therapy for Migraine Prevention in Children 6-11 Years of Age
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Conditions:
Migraine Disorders
Headache Disorders
Eligibility:
All Genders
6-11 years
Phase:
PHASE4
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.
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. This is a multicenter, randomized, double-blind, pla...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04050293
Start Date
July 16 2020
End Date
May 29 2024
Last Update
November 21 2025
Active Locations (1)
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1
CNS Healthcare
Memphis, Tennessee, United States, 38119