drugset / Trial / NCT03447782

Endogenous Modulation and Central Sensitization in New Daily Persistent Headache ( NDPH ) in Children

NCT03447782

Phase 1/2 Completed 45 enrolled Boston Children's Hospital
Non-randomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2018-07-23
Primary completion
2020-11-20
Completion
2020-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule 4.5 mg Oral

Indications