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

NCT02425176 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-04-23

No results posted yet for this study

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.

Conditions

  • Sialorrhea

Interventions

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

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.

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.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • MAZLINA MAZLAN, MBBS, MRM · University of Malaya

  • SAINI ABDULLAH, MBBS, MRM · KPJ KL REHABILITATION CENTRE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2014-02-28
Completion
2014-04-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02425176 on ClinicalTrials.gov