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

• Status: Completed
• Trial end date: 2020-11-20
• Target enrollment: 0
• Participant gender: All

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. In non-responding patients, they further aim to investigate low-dose naltrexone for the treatment of new daily persistent headache.

Adolescents ages 10-17 will be recruited from Boston Children's Hospital Pediatric Headache Program.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

1) Patients meeting clinical International Classification of Headache Disorders (ICHD-3 )classification for NDPH 2) Age 10-17 years, all sexes, races, and ethnicities 3) English speaking 4) Able to wean off headache prophylactic medication 2 weeks prior to start of Naltrexone trial (patient will still be able to use abortive medication throughout the duration of the study) 5) On stable psychotropic medication for mild anxiety and/or mood disturbance for 2 weeks

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Exclusion Criteria:

1) Children and adolescents with significant chronic medical illness: Central Nervous systen (secondary headache disorder other than mild traumatic brain injury); Cardiac, Pulmonary other than stable asthma, Metabolic, Renal, Hepatic 2) Significant psychiatric disorder, such as major depression, somatization disorder, and psychosis 3) Pregnancy 4) Intellectual delay or cognitive limitations precluding completion of questionnaires or following instructions.

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