Clinical Trial: Botulinum Toxin-A for Sialorrhoea Treatment in Asian Adults With Neurological Diseases
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-blind Randomised Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhoea Treatment in Asian Adults With Neurological Disease
Brief 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.
Detailed Summary:
Study Objectives:
To determine the efficacy, safety, tolerability and adverse effects of three doses of Dysport® (50MU, 100MU and 200MU) in the treatment of sialorrhoea in Asian patients with neurological disorders/diseases and to determine the most efficacious dose.
Study design:
Dose-ranging double blind pilot study.
Sample size:
At least 30 adult patients with various neurological disorders complicated with sialorrhoea including stroke, motor neurone disease, traumatic brain injury and Parkinsonism would be divided into 3 dosing groups.
Study method:
Patients who satisfy inclusion criteria and have given informed consent would be randomized into 3 equal groups given different total doses-50MU, 100MU, 200MU. The total dose will be divided equally and give to each of 4 salivary glands viz. the submandibular and parotid gland bilaterally. For example, if 200MU is to be given in total, 50MU would be given to each gland. Injections would be given via a 25G needle to each gland with ultrasound guidance for better needle placement. One site will be injected per gland.
Primary outcome measure The percentage reduction in the rate of saliva production (as measured by difference in mean weight of dental rolls per minute from baseline) for each of the groups given different doses of Dysport® at 2,6,12 and 24 weeks post injection.
Secondary outcome measure
- Patient's subjective assessment of improvem
Sponsor: University of Malaya
Current Primary Outcome: Change from baseline in the amount of saliva produced within 6 months [ Time Frame: 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
Original Primary Outcome: Same as current
Current Secondary Outcome: subjective report of sialorrhea/ drooling within 6 months post injection [ Time Frame: 2,6,12 and 24 weeks post injection ]
subjective report of sialorrhea using the Drooling Frequency and Severity Scale (DFS).
Original Secondary Outcome: Same as current
Information By: University of Malaya
Dates:
Date Received: April 9, 2015
Date Started: September 2009
Date Completion:
Last Updated: April 20, 2015
Last Verified: April 2015
