A Phase 2/3 interventional study of Botulinum toxin A (BoNT-A) 50U and Botulinum toxin A (BoNT-A) 100U in Sialorrhea, sponsored by University of Malaya. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-23.
Sponsored by University of Malaya · Phase 2/3, Interventional, and Treatment
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.
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
60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.
This study's enrollment of 30 is close to the median of 31 across 44 interventional studies indexed under Sialorrhea.
Browse Sialorrhea studies →University of Malaya is the lead sponsor of 284 studies on the registry; 58 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug 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
Drug: Botulinum toxin A (BoNT-A) 50U
Drug 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
Drug: Botulinum toxin A (BoNT-A) 100U
Drug 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
Drug: Botulinum toxin A (BoNT-A) 200U
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
Also known as: Dysport
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.
Also known as: Dysport
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.
Also known as: Dysport
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
Time frame: 2,6,12 and 24 weeks post injection
subjective report of sialorrhea/ drooling within 6 months post injection
subjective report of sialorrhea using the Drooling Frequency and Severity Scale (DFS).
Time frame: 2,6,12 and 24 weeks post injection
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: incobotulinumtoxinA