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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Malaya
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

1. Patients ≥ 18 years old.

2. Patients with neurological disorder including stroke, motor neurone disease, traumatic brain injury and Parkinsonism, diagnosis confirmed clinically by their treating physicians.

3. Patients with a Thomas-Stonell Drooling Frequency and Severity Scale combined drooling ranking of ≥5.

4. Patients who are able to give signed informed consent and are willing and able to comply with scheduled visits, treatment plan and other study procedure.

Exclusion Criteria:

1. Patients who are pregnant.

2. Patients with bleeding disorders or who are on anticoagulants.