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

Sialorrhea Clinical Trial

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 Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425176
• Other study ID #: UMMC ETHICS 660.1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 9, 2015
• Last updated: April 20, 2015
• Start date: September 2009
• Est. completion date: April 2014

Study information

• Verified date: April 2015
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

1. Patient's subjective assessment of improvement in sialorrhoea using the Drooling Frequency and Severity Scale (Thomas-Stonell scale) at 2,6,12 and 24 weeks post-injection.

2. Duration to maximum reduction in salivation (as measured by the maximum reduction in weight of dental rolls)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nervous System Diseases
• Sialorrhea

Intervention

Drug:
• Botulinum toxin A (BoNT-A) 50U
Drug intervention: The total dose is divided equally and injected into 4 salivary glands (submandibular and parotid gland bilaterally) via a 25G or 23G needle with ultrasound guidance. One site is injected per gland. Drug is only injected once at baseline
• Botulinum toxin A (BoNT-A) 100U
The total dose is divided equally and injected into 4 salivary glands (submandibular and parotid gland bilaterally) via a 25G or 23G needle with ultrasound guidance. One site is injected per gland.
• Botulinum toxin A (BoNT-A) 200U
The total dose is divided equally and injected into 4 salivary glands (submandibular and parotid gland bilaterally) via a 25G or 23G needle with ultrasound guidance. One site is injected per gland.

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur	W.persekutuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the amount of saliva produced within 6 months	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	2,6,12 and 24 weeks post injection	No
Secondary	subjective report of sialorrhea/ drooling within 6 months post injection	subjective report of sialorrhea using the Drooling Frequency and Severity Scale (DFS).	2,6,12 and 24 weeks post injection	No