Phase 2
N=45
Endogenous Modulation and Central Sensitization in New Daily Persistent Headache ( NDPH ) in Children
New Daily Persistent Headache (NDPH)
Bottom Line
View on ClinicalTrials.gov: NCT03447782 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Pain Intensity — 5.82; 4.92 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Naltrexone HCl (Bulk) Powder (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity |
5.82; 4.92 | — |
| SECONDARY Functional Disability |
15.16; 10.96 | — |
| SECONDARY Self- Perceived Pain Sensitivity |
3.21; 3.22 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
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Exclusion Criteria
- 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.
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Data sourced from ClinicalTrials.gov (NCT03447782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.