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NCT03447782 · ClinicalTrials.gov registry record · Phase 1
Endogenous Modulation and Central Sensitization in New Daily Persistent Headache ( NDPH ) in Children
A Phase 1 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT03447782 is a Phase 1 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 45 participants.
The verdict
NCT03447782, a Phase 1 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study 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.
Interventions
- DRUG Naltrexone HCl (Bulk) Powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-07-23 |
| Est. Completion | 2020-11-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03447782
The ClinicalTrials.gov registry entry for NCT03447782 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Naltrexone HCl (Bulk) Powder is the first listed.
NCT03447782 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03447782 about?
NCT03447782 is a clinical study titled "Endogenous Modulation and Central Sensitization in New Daily Persistent Headache ( NDPH ) in Children". 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 wh...
What is the current status of trial NCT03447782?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2018-07-23. Estimated completion is 2020-11-20.
What interventions are being tested in trial NCT03447782?
The interventions under investigation include: Naltrexone HCl (Bulk) Powder (DRUG).
Who is sponsoring clinical trial NCT03447782?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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