drugset / Trial / NCT02425176

Botulinum Toxin-A for Sialorrhoea Treatment in Asian Adults With Neurological Diseases

NCT02425176

Phase 2/3 Completed 30 enrolled University of Malaya
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The efficacy of Botulinum toxin A (BoNT-A) in Asian population has not been properly studied and there is no literature available on the most efficacious dose of BoNT-A for sialorrhoea treatment. This research is aimed to find the dose of Dysport® that would be efficacious without treatment-related adverse events and the duration of effectiveness of the drug for sialorrhea treatment in Malaysian patients. The efficacy, safety, tolerability and adverse effects of three doses of Dysport®(50MU, 100MU and 200MU) are examined at 2,6,12 and 24 weeks post injection in this double-blinding, randomized trial.

Timeline

Start
2009-09
Primary completion
2014-02
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 50 iu Other
Comparator Botulinum toxin type A Protein / enzyme biologic 100 iu Other
Comparator Botulinum toxin type A Protein / enzyme biologic 200 iu Other

Indications

No indication recorded.