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

  • STATUS
    Not Recruiting
  • participants needed
    150
  • sponsor
    Boston Children’s Hospital
Updated on 2 August 2021
Investigator
Alyssa LeBel, MD
Primary Contact
Boston Childrens Hospital (3.9 mi away) Contact

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.

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 who recover within a few months and those who do not.

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.

Details
Condition New Daily Persistent Headache (NDPH), New Daily Persistent Headache (NDPH), New Daily Persistent Headache (NDPH)
Treatment Naltrexone HCl (Bulk) Powder
Clinical Study IdentifierNCT03447782
SponsorBoston Children’s Hospital
Last Modified on2 August 2021

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