At a glance
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Endogenous Modulation and Central Sensitization in New Daily Persistent Headache ( NDPH ) in Children
In Brief
A Phase 2 clinical trial evaluating Naltrexone HCl (Bulk) Powder for New Daily Persistent Headache (NDPH). Completed, enrolled 45 participants across 1 site.
Detailed Summary
New daily persistent headache (NDPH) is a primary headache disorder characterized by the daily and unremitting headache pain patients experience with a distinct onset. Despite the known significant impairment associated with NDPH, the process by which some patients with NDPH recover within months while others do not is unknown. The investigators propose to refine the clinical definition and suggest a novel mechanism underlying new daily persistent headache (NDPH) in adolescents. They further aim to investigate low-dose naltrexone for the treatment of new daily persistent headache. Healthy controls will also be enrolled in order to investigate the existence of a biomarker for NDPH. Adolescents ages 10-17 will be recruited from Boston Children's Hospital Pediatric Headache Program.
Study Details
Timeline
Interventions
For the NDPH Persistent group, patient will take naltrexone, 4.5 mg, po 1 time/day for three months-Naltrexone will be compounded from Naltrexone HCL powder