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Headaches in children and adolescents have high incidence and prevalence rates, with consequent elevated disability costs to individuals and the community. Pediatric migraine is a disorder with substantial clinical differences compared to the adult form. Few clinical trials have been performed specifically on primary headache in pediatric populations using acute and preventative treatments, often with conflicting findings. The limited high-quality data on the effectiveness of treatments are also due to the high placebo effect, in terms of reductions in both the frequency and intensity of migraine attacks in the pediatric population. The recent introduction of calcitonin gene-related peptide (CGRP) pathway inhibitors and ditans is changing the treatment of migraine, but the majority of the data are still limited to adulthood. Thus, few drugs have indications for migraine treatment in the pediatric age group, and limited evidence gives guidance as to the choice of pharmacotherapy.
Treatments and Comparators | Status | Phase | Diagnosis | Age Range | Primary Endpoint | Planned Patients/Treatment Duration | Trial Number |
---|---|---|---|---|---|---|---|
1. Alpha lipoic acid 300mg 2. Flunarizine 5 mg |
Recruiting | IV; open label | Chronic migraine | 10 to 19 Years | Mean monthly migraine attack rate | 60/12 weeks | NCT04064814 [41] |
Erenumab three doses adjusted by weight | Recruiting | I; open label | Migraine with or without aura | 6 to 17 Years | Serum PK parameter Cmax, tmax, AUC 0–28 days, Cthrough; treatment emergent adverse events; heart rate; body temperature; blood pressure; duration and morphology of P, QRS, and T waves in ECG; standard hematology lab assessment and chemistry; standard sensory and motor assessment of body and PNS and CNS | 60/12 up to 52 weeks | NCT03499119 [31] |
1. Erenumab three doses adjusted by weight 2. Placebo |
Recruiting | III | Episodic migraine with or without aura | 6 to 11 Years; 12 to 17 years | Change from baseline in MMDs | 456/12 weeks | NCT03836040 [32] |
1. Erenumab three doses adjusted by weight 2. Placebo |
Recruiting | III | Chronic migraine | 6 to 11 Years; 12 to 17 years | Change from baseline in MMDs | 286/12 weeks | NCT03832998 [33] |
Eptinezumab adjusted by weight | Recruiting | I | Migraine with or without aura | 6 to 17 Years | Area under curve (AUC) (0–infinity) eptinezumab; Cmax eptinezumab | 32/20 weeks | NCT04537429 [37] |
Eptinezumab 100 mg IV or 300 mg IV adjusted by weight | Recruiting | III | Migraine with or without aura and chronic migraine | 6 to 17 Years | Number of participants with treatment-emergent adverse events | 610/44 weeks | NCT05164172 [38] |
1. Eptinezumab (300 or 100 mg IV adjusted by weight) 2. Placebo |
Recruiting | III | Chronic migraine | 12 to 17 Years | Change from baseline in MMDs averaged over weeks 1–12 | 285/12 weeks | NCT04965675 [39] |
Fremanezumab dose adjusted by weight | Recruiting | III; open label | Migraine with or without aura and chronic migraine | 6 to 17 Years | Incidence of AEs; incidence of participants with clinically significant changes in laboratory values; incidence of abnormal ECG findings; incidence of abnormal vital signs; incidence of abnormal physical examination findings; suicidal ideation | 550/56 weeks | NCT04530110 [36] |
1. Galcanezumab 2. Placebo |
Recruiting | III | Migraine with or without aura | 6 to 17 Years | Change from baseline in the number of monthly migraine headache days | 325/3 months | NCT03432286 [34] |
1. Galcanezumab 2. Placebo |
Recruiting | III | Chronic migraine | 12 to 17 Years | Change from baseline in the number of monthly migraine headache days | 300/3 months | NCT04616326 [35] |
1. OnabotulinumtoxinA 2. Placebo |
Active, not recruiting | II | Chronic migraine | 8 to 17 Years | Pain scores (intensity); change in duration of migraine episode; frequency of migraine; PedMIDAS scoring reduction; opioid consumption | 26 patients/48 weeks | NCT03055767 [42] |
1. Rimegepant 75 or 50 mg 2. Placebo |
Active, not yet recruiting | III | Episodic migraine with or without aura | 6 to 17 Years | Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase | 1100/12 weeks | NCT05156398 [40] |
1. Topiramate ER capsules 2. Placebo |
Recruiting | IV | Migraine with or without aura | 6 to 11 Years | Frequency of migraine attack per 28 days during the treatment phase. | 162/28 days | NCT04050293 [43] |
1. Topiramate ER capsules 2. Placebo |
Recruiting | IV | Migraine with or without aura | 6 to 11 Years | Change from baseline (last 28 days run-in period) in the monthly number of headache days during the 8-week maintenance period based on the diary. | 132/16 weeks | NCT04748601 [44] |