Treatment of Drooling With Type A Botulinum Toxin in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Treatment of Drooling With Type A Botulinum Toxin A in Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00173745
• Other study ID #: 9100012973
• Secondary ID: NSC93-2614-B-002
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: December 20, 2005
• Start date: June 2003
• Est. completion date: September 2005

Study information

• Verified date: July 2002
• Source: National Taiwan University Hospital
• Contact: Jern Yi Shieh, MD
• Phone: 886-2-23123456
• Email: JYSHIEH[@]HA.MC.NTU.EDU.TW
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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 and side effects.

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, affect articulation of the patients, and increase the risk of aspiration and dehydration. Many options, including various therapies, medications, surgeries and radiation, have been proposed to treat drooling. Yet none of these is universally successful and many have potential complications. Nerve endings of the parasympathetic post-ganglionic neurons secret aceylcholine. Botulinum toxin should be able to inhibit salivary gland secretion by blocking the release of acetylcholine. Very limited case series had proved fair result of botulinum toxin injection to treat drooling. However, most of the subjects were adult patients with neurological disorders. 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 and side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 21 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Drooling

Intervention

Drug:
• botulinum toxin A injection

Locations

Country	Name	City	State
Taiwan	National Taiwan University hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effectiveness of botulinum toxin in treatment of drooling
Secondary	the most appropriated dosage of treatment
Secondary	duration of effect
Secondary	side effects