Status:
UNKNOWN
Treatment of Drooling With Type A Botulinum Toxin in Children With Cerebral Palsy
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Conditions:
Cerebral Palsy
Drooling
Eligibility:
All Genders
6-21 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect a...
Detailed Description
Sialorrhea, or drooling, has been reported to be a significant problem in 10%to 37% of patients with cerebral palsy. Excessive drooling may cause skin maceration, increased the burden of caregiver, af...
Eligibility Criteria
Inclusion
- diagnosis of cerebral palsy
- severe drooling
- aged 6-21 yrs
- subjects (or their guardian) who are able to understand the requirements of the study and sign the informed consent form
Exclusion
- age below 6 yrs or above 21 yrs
- known allergy or sensitivity to the study medication or its component
- diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function
- subjects who have prior surgery of the submandibular gland
- subjects who are receiving medication that affect drooling such as anticholinergic drug
- inability to give informed consent
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00173745
Start Date
June 1 2003
End Date
September 1 2005
Last Update
December 21 2005
Active Locations (1)
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1
National Taiwan University hospital
Taipei, Taiwan