A Phase 1/2 interventional study of Naltrexone HCl (Bulk) Powder in New Daily Persistent Headache (NDPH), sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-06.
Sponsored by Boston Children's Hospital · Phase 1/2, Interventional, and Diagnostic
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.
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.
145 studies on the registry are indexed under Headache Disorders; 37 are open to participants now.
This study's enrollment of 45 is below the median of 60 across 98 interventional studies indexed under Headache Disorders.
Browse Headache Disorders studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
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Exclusion Criteria:
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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
These participants will be in the research study for the initial visit only. They will be evaluated by a physician or nurse practitioner
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
Pain Intensity
1. A change in pain intensity scores and headache frequency from visit 1 (V1) compared to visit 4 (V4) for NDPH patients after naltrexone has been administered for approximately 3 months. 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.
Time frame: 3 months
Functional Disability
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 for NDPH 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.
Time frame: 3 months
Self- Perceived Pain Sensitivity
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 persistent patients and healthy controls. 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.
Time frame: 3 months
| Milestone | NDPH Persistent |
|---|---|
| Started | 45 |
| Completed | 25 |
| Not completed | 20 |
1. A change in pain intensity scores and headache frequency from visit 1 (V1) compared to visit 4 (V4) for NDPH patients after naltrexone has been administered for approximately 3 months. 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.
| score on a scale | NDPH Persistent |
|---|---|
| V1 Pain Rating | 5.82 ± 1.47 |
| V4 Pain Rating | 4.92 ± 1.64 |
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 for NDPH 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.
| score on a scale | NDPH Persistent |
|---|---|
| FDI V1 | 15.16 ± 8.56 |
| FDI V4 | 10.96 ± 8.46 |
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 persistent patients and healthy controls. 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.
| units on a scale | NDPH Persistent |
|---|---|
| PSQ total V1 | 3.21 ± 1.03 |
| PSQ total V4 | 3.22 ± 1.50 |
Collected over 4-7 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NDPH Persistent | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
The healthy control arm was not included here as COVID-19 necessitated the shut-down of this study and no healthy controls were able to be recruited.
| Age, Categorical(Participants) | NDPH Persistent |
|---|---|
| <=18 years | 45 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | NDPH Persistent |
|---|---|
| Mean | 15.7 ± 1.32 |
| Sex: Female, Male(Participants) | NDPH Persistent |
|---|---|
| Female | 38 |
| Male | 7 |
| Race/Ethnicity, Customized(Participants) | NDPH Persistent |
|---|---|
| White or Caucasian | 36 |
| Other | 2 |
| Black or African American | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Native American or Alaskan Native | 0 |
| Unknown | 7 |
| Region of Enrollment(participants) | NDPH Persistent |
|---|---|
| United States | 45 |
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Studies of the drug tested here: Naltrexone