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NCT04725383 · ClinicalTrials.gov registry record · Phase 3
Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders
A Phase 3 study, sponsored by University of Missouri, Kansas City.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT04725383: Clinical Trial Phase 3 study, sponsored by University of Missouri, Kansas City.
NCT04725383 is a Phase 3 study that was terminated before completion, run by University of Missouri, Kansas City. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04725383, a Phase 3 study, was terminated before completion, sponsored by University of Missouri, Kansas City.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
The investigators will recruit 30 children and adolescents (15 per group x 2 groups) aged 6 to 17 years with ASD and significant repetitive behaviors that cause problems to them and to others around them. Subjects will be randomized to either amitriptyline (AMI), dosed flexibly according to response and tolerability with a maximum dose of 100mg per day or 1.5mg/kg/day, in divided doses to minimize side effects, or placebo in look-alike capsules, for 10 weeks. Rating scales will be used to measure outcomes.
Primary Outcome
1 Very Much Improved to 7 Very Much Worse
Interventions
- DRUG amitriptyline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2025-05-23 |
| Phase | Phase 3 |
Why NCT04725383 stopped before completion
NCT04725383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which amitriptyline is the first listed.
NCT04725383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04725383 about?
NCT04725383 is a clinical study titled "Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders". The investigators will recruit 30 children and adolescents (15 per group x 2 groups) aged 6 to 17 years with ASD and significant repetitive behaviors that cause problems to them and to others around them. Subjects will be randomized to either amitriptyline (AMI), dosed flexibly according to response...
What is the current status of trial NCT04725383?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2023-11-01. Estimated completion is 2025-05-23.
What interventions are being tested in trial NCT04725383?
The interventions under investigation include: amitriptyline (DRUG).
Who is sponsoring clinical trial NCT04725383?
This trial is sponsored by University of Missouri, Kansas City, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04725383's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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