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

NCT03447782 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: P00026929
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

New Daily Persistent Headache (NDPH)

Keywords

New Daily Persistent Headache; Chronic Headache

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

• Functional Disability

  3 months

• Self- Perceived Pain Sensitivity

  3 months

Study Arms (2)

NDPH Persistent

EXPERIMENTAL

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

Healthy Controls

NO INTERVENTION

These participants will be in the research study for the initial visit only. They will be evaluated by a physician or nurse practitioner

Interventions

Naltrexone HCl (Bulk) Powder DRUG

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

NDPH Persistent

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \) 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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Childrens Hospital

Boston, Massachusetts, 02453, United States

Location

MeSH Terms

Conditions

Headache Disorders

Interventions

Naltrexone; Dietary Fiber; Powders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

This trial had to shut down due to the emergence of the COVID-19 virus in 2020. Because of this, our sample size is smaller than anticipated and thus serves as a limitation of our trial. Additionally, healthy controls were extremely difficult to recruit for the study given the COVID-19 pandemic and thus we were unable to adequately compare NDPH patients to healthy controls.

Results Point of Contact

• Title: Dr. Alyssa Lebel
• Organization: Boston Children's Hospital

alyssa.lebel@childrens.harvard.edu

7812161960

Study Officials

• Alyssa Lebel, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Chronic Headache Program, Boston Children's Hospital ( BCH ); Associate Professor of Anesthesiology, HMS

Model Details: 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

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 27, 2018
• Study Start: July 23, 2018
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: May 6, 2022
• Results First Posted: May 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)