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NCT03367429 · ClinicalTrials.gov registry record · Phase 4
The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination
A Phase 4 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT03367429: Clinical Trial Phase 4 study, sponsored by Weill Medical College of Cornell University.
NCT03367429 is a Phase 4 study that was terminated before completion, run by Weill Medical College of Cornell 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
NCT03367429, a Phase 4 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
Despite the wide-spread use of botulinum toxin (BT) to treat spasticity (increased muscle tone) in central neurological disease, evidence-based guidance on dosing, dilution, and injection technique is limited. The wide-spread use of BT in spasticity management, expense of these agents, and detrimental impact from movement into non-injected muscles mandates a better understanding of BT movement within muscles. A proof-of-concept paper written by investigators at Weill Cornell Medicine introduced a non-invasive MRI approach with "voxel thresholds" that was able to detect intramuscular effects of BT at 2 and 3 months post-injection of BT. The purpose of the current set of studies is to refine this MRI technique to better visualize the movement of botulinum toxin through muscle. In addition, the investigators plan to explore, using the imaging technique, how spastic muscle and differing dilutions affect BT movement in an effort to support the development of better research techniques to study toxin movement in human muscle.
Primary Outcome
BTME volume is calculated by counting the number of abnormal voxels (each voxel volume is .0015 cc) on MRI2, which have a relaxation time greater than or equal to 3 standard deviations above the baseline mean for a subject and their muscle found on their baseline MRI.
Interventions
- DRUG Botox
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2019-09-18 |
| Phase | Phase 4 |
Why NCT03367429 stopped before completion
NCT03367429 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 Botox is the first listed.
NCT03367429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03367429 about?
NCT03367429 is a clinical study titled "The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination". Despite the wide-spread use of botulinum toxin (BT) to treat spasticity (increased muscle tone) in central neurological disease, evidence-based guidance on dosing, dilution, and injection technique is limited. The wide-spread use of BT in spasticity management, expense of these agents, and detriment...
What is the current status of trial NCT03367429?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2018-06-15. Estimated completion is 2019-09-18.
What interventions are being tested in trial NCT03367429?
The interventions under investigation include: Botox (DRUG).
Who is sponsoring clinical trial NCT03367429?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03367429'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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