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NCT03367429
The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination
Phase 4 trial testing Botox in Stroke in 4 participants. Terminated before completion.
18 September 2019
Quick facts
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 4 |
| Start date | 15 June 2018 |
| Primary completion | 18 September 2019 |
| Estimated completion | 18 September 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Botox (ONABOTULINUMTOXINA) — full drug profile →
Conditions studied
- Stroke — all drugs for Stroke →
- Muscle Spasticity — all drugs for Muscle Spasticity →
Sponsor
Weill Medical College of Cornell University
Who can join
Adults 30 to 75, any sex, with Stroke or Muscle Spasticity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03367429
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03367429 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Weill Medical College of Cornell University
- Last refreshed: 29 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03367429.
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