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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 May 2015 |
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Main ID: |
NCT02425176 |
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Date of registration:
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09/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Botulinum Toxin-A for Sialorrhoea Treatment in Asian Adults With Neurological Diseases
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Scientific title:
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A Double-blind Randomised Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhoea Treatment in Asian Adults With Neurological Diseases |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02425176 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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SAINI ABDULLAH, MBBS, MRM |
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Address:
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Telephone:
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Email:
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Affiliation:
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KPJ KL REHABILITATION CENTRE |
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Name:
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MAZLINA MAZLAN, MBBS, MRM |
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Address:
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Telephone:
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Email:
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Affiliation:
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UNIVERSITY MALAYA |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sialorrhea
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Intervention(s)
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Drug: Botulinum toxin A (BoNT-A) 100U
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Drug: Botulinum toxin A (BoNT-A) 200U
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Drug: Botulinum toxin A (BoNT-A) 50U
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Primary Outcome(s)
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Change from baseline in the amount of saliva produced within 6 months
[Time Frame: 2,6,12 and 24 weeks post injection]
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Secondary Outcome(s)
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subjective report of sialorrhea/ drooling within 6 months post injection
[Time Frame: 2,6,12 and 24 weeks post injection]
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Secondary ID(s)
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UMMC ETHICS 660.1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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