Status:
COMPLETED
Endogenous Modulation and Central Sensitization in New Daily Persistent Headache ( NDPH ) in Children
Lead Sponsor:
Boston Children's Hospital
Conditions:
New Daily Persistent Headache (NDPH)
Eligibility:
All Genders
10-17 years
Phase:
PHASE1
PHASE2
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 im...
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
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Key Trial Info
Start Date :
July 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03447782
Start Date
July 23 2018
End Date
November 20 2020
Last Update
May 6 2022
Active Locations (1)
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1
Boston Childrens Hospital
Boston, Massachusetts, United States, 02453