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

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ClinicalTrials.gov Identifier: NCT03447782
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Alyssa Lebel, MD, Boston Children’s Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
New Daily Persistent Headache (NDPH) Drug: Naltrexone HCl (Bulk) Powder Phase 1 Phase 2

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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group 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
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Endogenous Modulation and Central Sensitization in New Daily Persistent Headache ( NDPH ) in Children
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: NDPH Persistent

Patients will be evaluated in clinic 1 month after the phone call evaluation. At this time, patients will begin a 3 month trial of low-dose naltrexone (Naltrexone HCL powder compounded to provide 4.5mg once per day orally).

Patients will be evaluated in clinic 3 months after beginning treatment with naltrexone.

Drug: Naltrexone HCl (Bulk) Powder
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




Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: 3 months ]
    1. A change in pain intensity scores and headache frequency- The NRS, numerical rating scale will be used, with a pain score between 0 to 10, with 0 being no pain and 10 being worst pain imaginable, for NDPH patients, chronic and recovered, completing 3 months of naltrexone, as compared to a cohort of patients with NDPH on standard treatment.


Secondary Outcome Measures :
  1. Functional disability [ Time Frame: 3 months ]

    1. A change in functional disability scores - The functional disability inventory (FDI) will be used to assess differences in disability pre- and post-naltrexone treatment, as well as between recovered and persistent patients.

    The FDI is a valid and reliable measure consisting of 15 items concerning perceptions of physical and psychosocial function. Total scores range from 0 to 60, with higher scores indicating greater disability.


  2. Self- Perceived Pain Sensitivity [ Time Frame: 3 months ]
    A change in self-perceived pain sensitivity - The Pain Sensitivity Questionnaire (PSQ) will be used to assess differences in pain sensitivity pre- and post-naltrexone treatment, as well as between recovered and persistent patients.The Pain Sensitivity Questionnaire (PSQ) PSQ is a valid 17 item self-report measure of pain sensitivity. Each item is rated on a scale of 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The PSQ will be used to assess differences in pain sensitivity pre- and post-naltrexone treatment, as well as between recovered and persistent patients.



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447782


Contacts
Contact: Alyssa LeBel, MD 781-216-1960 alyssa.lebel@childrens.harvard.edu
Contact: Bethany Zettler, BS 781-216-1960 bethany.zettler@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Childrens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Alyssa LeBel, MD    781-216-1960    alyssa.lebel@childrens.harvard.edu   
Contact: Bethany Zettler, BS    781-216-1960    bethany.zettler@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Principal Investigator: Alyssa Lebel, MD Boston Children’s Hospital

Responsible Party: Alyssa Lebel, MD, Director, Chronic Headache Program, Boston Children's Hospital ( BCH ); Associate Professor of Anesthesiology, HMS, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03447782     History of Changes
Other Study ID Numbers: P00026929
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alyssa Lebel, MD, Boston Children’s Hospital:
New Daily Persistent Headache
Chronic Headache

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents