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NCT03726996 · ClinicalTrials.gov registry record · Phase 4
Desipramine in Infantile Neuroaxonal Dystrophy (INAD).
A Phase 4 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT03726996: Clinical Trial Phase 4 study, sponsored by Duke University.
NCT03726996 is a Phase 4 study that was terminated before completion, run by Duke University. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03726996, a Phase 4 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a research study to find out if clinically prescribed desipramine is effective at improving the symptoms and slowing the progression of Infantile Neuroaxonal Dystrophy (INAD) in affected children. Participants will receive an initial oral dose of study drug once a day. This dose may be changed depending on response to study drug Clinically collected data will be recorded for up to 5 years. Investigators will also ask for participant permission to obtain a sample of child's skin biopsy from unused clinical sample previously collected for standard of care.
Primary Outcome
The Gross Motor Function Measure (GMFM-66) is a 66 item standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. Items are ordered in terms of difficulty and a unit of change has the same meaning throughout the scale ranging from 0 to 100. 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Scoring the GMFM-66 requires the use of a computer program called the Gross Motor Ability Est
Interventions
- DRUG Desipramine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-01-14 |
| Est. Completion | 2019-08-30 |
| Phase | Phase 4 |
Why NCT03726996 stopped before completion
NCT03726996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Desipramine is the first listed.
NCT03726996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03726996 about?
NCT03726996 is a clinical study titled "Desipramine in Infantile Neuroaxonal Dystrophy (INAD).". This is a research study to find out if clinically prescribed desipramine is effective at improving the symptoms and slowing the progression of Infantile Neuroaxonal Dystrophy (INAD) in affected children. Participants will receive an initial oral dose of study drug once a day. This dose may be chan...
What is the current status of trial NCT03726996?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2019-01-14. Estimated completion is 2019-08-30.
What interventions are being tested in trial NCT03726996?
The interventions under investigation include: Desipramine (DRUG).
Who is sponsoring clinical trial NCT03726996?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03726996's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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