Endogenous Modulation and Central Sensitization in New Daily Persistent Headache ( NDPH ) in Children
Condition: New Daily Persistent Headache (NDPH)
MeSH terms: Headache
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      The purpose of this study is to investigate low-dose naltrexone for the treatment of new
      daily persistent headache (NDPH) in adolescents ages 10-17. New daily persistent headache
      (NDPH) is a primary headache disorder characterized by continuous pain experienced for at
      least 3 months from distinct onset. Patients with NDPH have compromised academic performance,
      school absence, anxiety, depressed mood, sleep impairment, family disruption, and high health
      care costs. 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. With the
      goal of enhancing the clinical definition of NDPH, investigators will describe differences
      between patients with NDPH and healthy controls.

      Additionally, little is known about which medications effectively manage and treat NDPH. One
      proposed medication that may benefit children and adolescents with NDPH is low-dose
      naltrexone. Naltrexone is an anti-inflammatory agent, similar to the opioid antagonist
      naloxone. Naltrexone is an effective treatment for opioid addiction, however, it was recently
      discovered that when taken in low doses (1/10 of the typical dose) naltrexone is capable of
      reducing the severity of chronic pain symptoms. By acting on glial cells in the nervous
      system as well as other receptors in the brain, naltrexone is capable of exerting analgesic
      effects. With this analgesic property, it has been speculated that low-dose naltrexone may be
      an effective treatment for the management of several chronic pain conditions, including
      headache.

      Although more research must be conducted to evaluate long-term effects of using low-dose
      naltrexone, prior studies show that there are little short-term consequences associated with
      using this drug as a form of treatment for chronic pain symptoms. Investigators aim to assess
      the efficacy and safety of low-dose naltrexone in the treatment of patients with NDPH.
    

Intervention name(s): Naltrexone HCl (Bulk) Powder
Intervention type(s): Drug
Intervention description(s): 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
Intervention MeSH terms: Naltrexone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This group includes patients reviewed after 3 months of observational study with NDPH who have not improved clinically-they will take naltrexone, 4.5 mg, for 3 months. The other group includes healthy control patients
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: New Daily Persistent Headache; Chronic Headache