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

NCT ID: NCT02425176

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-04-30

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.

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

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)

Conditions

Sialorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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 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

Group Type: ACTIVE_COMPARATOR

Botulinum toxin A (BoNT-A) 50U

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Botulinum toxin A (BoNT-A) 100U

Intervention Type: DRUG

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 toxina A (BoNT-A) 200U

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

Group Type: ACTIVE_COMPARATOR

Botulinum toxin A (BoNT-A) 200U

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Dysport; Dysport; Dysport

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Mazlina Mazlan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MAZLINA MAZLAN, MBBS, MRM

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

SAINI ABDULLAH, MBBS, MRM

Role: STUDY_CHAIR

KPJ KL REHABILITATION CENTRE

Locations

University Malaya Medical Centre

Kuala Lumpur, W.persekutuan, Malaysia

Countries

Malaysia

Other Identifiers

UMMC ETHICS 660.1

Identifier Type: -

Identifier Source: org_study_id