Therapy for Migraine Prevention in Children 6-11 Years of Age
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Headache Disorders
- Migraine Disorders
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Double-blind, randomized, placebo-controlled, 2-arm, parallel group studyMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 6 years and 11 years
- Gender
- Both males and females
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. SPN-538 (or matching placebo) will be administered in patients diagnosed with migraine with or without aura based on the International Headache Society c...
The study is to assess the efficacy and safety of SPN-538 in reducing the monthly migraine headache frequency in pediatric patients with migraine. SPN-538 (or matching placebo) will be administered in patients diagnosed with migraine with or without aura based on the International Headache Society criteria. The frequency of the migraine attack will be assessed as the primary outcome measure.
Tracking Information
- NCT #
- NCT04050293
- Collaborators
- Not Provided
- Investigators
- Not Provided
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