Botulinum Toxin-A for Sialorrhoea Treatment in Asian Adults With Neurological Diseases
A Double-blind Randomised Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhoea Treatment in Asian Adults With Neurological Diseases
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 9, 2015
CompletedFirst Posted
Study publicly available on registry
April 23, 2015
CompletedApril 23, 2015
April 1, 2015
4.4 years
April 9, 2015
April 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
subjective report of sialorrhea/ drooling within 6 months post injection
2,6,12 and 24 weeks post injection
Study Arms (3)
Botulinum toxin A (BoNT-A) 50U
ACTIVE COMPARATORDrug dilution and dosage: 1. Prepare a mother solution of 500 U/ml by diluting Botulinum toxin A Dysport® with 1 ml of 0.9% saline. 2. Prepare in 1 ml syringe to get 50U/ml :0.1 ml drawn from the mother solution and add 0.9 ml of 0,9% saline. Total volume of 1 ml. Intervention: Botulinum toxin A (BTX-A) 50U are divided equally into 4 salivary glands, 12.5U each gland
Botulinum toxin A (BoNT-A) 100U
ACTIVE COMPARATORDrug dilution and dosage: 1\. Prepare a mother solution of 500 U/ml by diluting Botulinum toxin A Dysport® with 1 ml of 0.9% saline. 2. Prepare in 1 ml syringe to get 100U/ml :0.2 ml drawn from the mother solution and add 0.8 ml of 0.9% saline. Total volume of 1 ml. Intervention: Botulinum toxin A (BTX-A) 100U are divided equally into 4 salivary glands, 25U each gland
Botulinum toxina A (BoNT-A) 200U
ACTIVE COMPARATORDrug dilution and dosage: 1\. Prepare a mother solution of 500 U/ml by diluting Botulinum ToxinA Dysport® with 1 ml of 0.9% saline. 2. Prepare in 1 ml syringe to get 200U/ml :0.4 ml is drawn from the mother solution and 0.6ml of 0.9% saline is added. Total volume of 1 ml. Intervention: Botulinum toxin A (BTX-A) 200U are divided equally into 4 salivary glands, 50U each gland
Interventions
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
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.
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.
Eligibility Criteria
You may qualify if:
- Patients ≥ 18 years old.
- Patients with neurological disorder including stroke, motor neurone disease, traumatic brain injury and Parkinsonism, diagnosis confirmed clinically by their treating physicians.
- Patients with a Thomas-Stonell Drooling Frequency and Severity Scale combined drooling ranking of ≥5.
- 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.
You may not qualify if:
- Patients who are pregnant.
- Patients with bleeding disorders or who are on anticoagulants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Malaya Medical Centre
Kuala Lumpur, W.persekutuan, 59100, Malaysia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MAZLINA MAZLAN, MBBS, MRM
University of Malaya
- STUDY CHAIR
SAINI ABDULLAH, MBBS, MRM
KPJ KL REHABILITATION CENTRE
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 9, 2015
First Posted
April 23, 2015
Study Start
September 1, 2009
Primary Completion
February 1, 2014
Study Completion
April 1, 2014
Last Updated
April 23, 2015
Record last verified: 2015-04