Migraine Disorders Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 162 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 11 Years |
Eligibility | 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, ß-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. |
Country | Name | City | State |
---|---|---|---|
United States | CNS Healthcare | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Supernus Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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