Therapy for Migraine Prevention in Children 6-11 Years of Age (NCT04050293) | Clinical Trial Compass
TerminatedPhase 4
Therapy for Migraine Prevention in Children 6-11 Years of Age
Stopped: Difficulty in recruitment
United States26 participantsStarted 2020-07-14
Plain-language 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.
Who can participate
Age range6 Years – 11 Years
SexALL
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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, 3-12 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 Criteria:
* 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, sedati…
What they're measuring
1
Change From Baseline in Monthly Migraine Days (MMDs) in Children 6 to 11 Years Old With Migraine.
Timeframe: 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)