Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Boston Children's Hospital.
NCT03447782 is a Phase 1 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT03447782 record still lists
NCT03447782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which Naltrexone HCl (Bulk) Powder is the first listed.
NCT03447782 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03447782's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00804154 · 45 participants · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
- NCT01851694 · 45 participants · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
- NCT02896335 · 45 participants · Phase 2
Palbociclib and Pembrolizumab In Central Nervous System Metastases
- NCT03454035 · 45 participants · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI