A Double-blind Randomised Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhoea Treatment in Asian Adults With Neurological Diseases

NCT02425176 Phase 2/Phase 3 COMPLETED

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.

Details

Lead sponsor	University of Malaya
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	30
Start date	2009-09
Completion	2014-04

Conditions

• Sialorrhea

Interventions

• Botulinum toxin A (BoNT-A) 50U
• Botulinum toxin A (BoNT-A) 100U
• Botulinum toxin A (BoNT-A) 200U

Primary outcomes

• Change from baseline in the amount of saliva produced within 6 months — 2,6,12 and 24 weeks post injection
  the amount of saliva produced was measured by the differential weight of a dental roll gauze placed in the buccal mucosal cavity calculated via an electronic microbalance scale to the nearest 0.0001 g

Countries

Malaysia