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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 is a Phase 3 study that was terminated before completion, run by University of Missouri, Kansas City. The registered enrollment target is 1 participants.
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.
Interventions
- DRUG amitriptyline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2025-05-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04725383
The ClinicalTrials.gov registry entry for NCT04725383 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri, Kansas City, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which amitriptyline is the first listed.
NCT04725383 reports 0 study locations.
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.
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