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NCT04695600
Onabotulinum Toxin A (Botox) in the Treatment of Transfer Dysphagia
Phase 2, PHASE3 trial testing Botulinum Toxin Type A Injection [Botox] in Transfer Dysphagia in 100 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | All India Institute of Medical Sciences |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 22 August 2023 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across India |
Drugs / interventions tested
- Botulinum Toxin Type A Injection [Botox] — full drug profile →
Conditions studied
- Transfer Dysphagia — all drugs for Transfer Dysphagia →
- Oropharyngeal Dysphagia — all drugs for Oropharyngeal Dysphagia →
- Cricopharyngeus Muscle Dysfunction — all drugs for Cricopharyngeus Muscle Dysfunction →
- Dysphagia, Late Effect of Stroke — all drugs for Dysphagia, Late Effect of Stroke →
Sponsor
All India Institute of Medical Sciences
Who can join
14 and older, any sex, with Transfer Dysphagia or Oropharyngeal Dysphagia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Dysphagia in patients with stroke, multiple sclerosis, parkinsonism or dystonia can occur due to relative hypertonia of the cricopharyngeus muscle. In the resting state, muscle is contracted and relaxes only during deglutition. Treatment of dysphagia by injecting botulinum toxin in the cricopharyngeus was described by Schneider et al. in 1994. More than 100 cases have been described after that, however there are no randomized controlled trials. A meta-analysis from Cochrane has also concluded that there is no sufficient evidence to conclude regarding the efficacy and safety of Botulinum toxin injection in cricopharyngeal dysfunction. So this study is necessary to fill this void in knowledge
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04695600
- Europe PMC full search
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Related trials
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Other All India Institute of Medical Sciences trials
Trials by the same sponsor.
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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 NCT04695600 (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 All India Institute of Medical Sciences
- Last refreshed: 13 September 2023
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