SialorrheaPhase 2/3NCT02425176

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

A Phase 2/3 study testing Botulinum toxin A (BoNT-A) 50U, Botulinum toxin A (BoNT-A) 100U and Botulinum toxin A (BoNT-A) 200U in people with Sialorrhea, run by University of Malaya at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sialorrhea
What is being tested?: Botulinum toxin A (BoNT-A) 50U, Botulinum toxin A (BoNT-A) 100U and Botulinum toxin A (BoNT-A) 200U
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteMalaysia
Study dates: Sep 2009to Apr 2014
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

University Malaya Medical Centre
Kuala Lumpur, W.persekutuan, 59100

Other trials in Malaysia

About this study

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

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.

Read the detailed 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

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

Conditions: Sialorrhea
Being tested: Botulinum toxin A (BoNT-A) 50U, Botulinum toxin A (BoNT-A) 100U, Botulinum toxin A (BoNT-A) 200U
Keywords: botulinum toxin, sialorrhoea, drooling
Medical subject headings: Sialorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Botulinum toxin A (BoNT-A) 50UDrug
Also called Dysport
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) 100UDrug
Also called 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.
Botulinum toxin A (BoNT-A) 200UDrug
Also called 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.

Study groups in NCT02425176
Study group	Role	What they receive
Botulinum toxin A (BoNT-A) 50U	Active comparator	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 Receives: Drug: Botulinum toxin A (BoNT-A) 50U
Botulinum toxin A (BoNT-A) 100U	Active comparator	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 Receives: Drug: Botulinum toxin A (BoNT-A) 100U
Botulinum toxina A (BoNT-A) 200U	Active comparator	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 Receives: Drug: Botulinum toxin A (BoNT-A) 200U

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2,6,12 and 24 weeks post injection

Secondary outcomes (1)

subjective report of sialorrhea/ drooling within 6 months post injection
subjective report of sialorrhea using the Drooling Frequency and Severity Scale (DFS).
Measured: 2,6,12 and 24 weeks post injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Apr 2014

First posted23 Apr 2015 (estimated)
Study startSep 2009
Primary completionFeb 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SialorrheaStudies of the same condition, open and under way.
More trials run by University of MalayaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02425176
Sponsor's protocol ID: UMMC ETHICS 660.1
Status last verified: Apr 2015
First submitted: 9 Apr 2015
Last updated: 23 Apr 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Local Vibration for Drooling in Children With Cerebral Palsy
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Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease
Transcutaneous Vagal Nerve Stimulation (tVNS), Parkinson Disease (PD)
Recruiting
Application of Neuro-electrostimulation as a Treatment for Patients With Dry Mouth
Saliva Altered
Not yet recruiting
Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
Cerebral Palsy (CP), Drooling
Active, not recruiting
Effect of SCS Technique on Oromotor Skills in Children With CP
Sialorrhea, Spastic Cerebral Palsy (sCP)

All Sialorrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02425176
Acronym / sponsor ID: UMMC ETHICS 660.1
Conditions: Sialorrhea
Keywords: botulinum toxin, sialorrhoea, drooling
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of MalayaUniversity, hospital or other
Study start: Sep 2009
Primary completion: Feb 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 23 Apr 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Objectives:

Study design:

Dose-ranging double blind pilot study.

Sample size:

Study method:

Secondary outcome measure

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Botulinum toxin A (BoNT-A) 50U	Active comparator	Drug: Botulinum toxin A (BoNT-A) 50UDrug 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 comparator	Drug: Botulinum toxin A (BoNT-A) 100UDrug 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 comparator	Drug: Botulinum toxin A (BoNT-A) 200UDrug 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Botulinum toxin A (BoNT-A) 50UAlso: DysportDrug 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	Drug	Botulinum toxin A (BoNT-A) 50U
Botulinum toxin A (BoNT-A) 100UAlso: DysportThe 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	Botulinum toxin A (BoNT-A) 100U
Botulinum toxin A (BoNT-A) 200UAlso: DysportThe 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	Botulinum toxina A (BoNT-A) 200U

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

1 secondary outcome

subjective report of sialorrhea/ drooling within 6 months post injection
Time frame: 2,6,12 and 24 weeks post injection

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.

Related trials for Sialorrhea

Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Active, not recruiting
Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease
Transcutaneous Vagal Nerve Stimulation (tVNS), Parkinson Disease (PD)
Recruiting
Application of Neuro-electrostimulation as a Treatment for Patients With Dry Mouth
Saliva Altered
Not yet recruiting
Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
Cerebral Palsy (CP), Drooling
Active, not recruiting
Effect of SCS Technique on Oromotor Skills in Children With CP
Sialorrhea, Spastic Cerebral Palsy (sCP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MAZLINA MAZLAN, MBBS, MRM principal investigator

University of Malaya

SAINI ABDULLAH, MBBS, MRM study chair

KPJ KL REHABILITATION CENTRE

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the amount of saliva produced within 6 months (time frame: 2,6,12 and 24 weeks post injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02425176.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015.