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

Study Description

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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 and side effects.

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy; Drooling	Drug: botulinum toxin A injection	Not Applicable

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, 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Treatment of Drooling With Type A Botulinum Toxin A in Children With Cerebral Palsy
Study Start Date :	June 2003
Study Completion Date :	September 2005

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. the effectiveness of botulinum toxin in treatment of drooling

Secondary Outcome Measures :

1. the most appropriated dosage of treatment
2. duration of effect
3. side effects

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 21 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Jern Yi Shieh, MD	886-2-23123456 ext 7190	JYSHIEH@HA.MC.NTU.EDU.TW
Contact: Pey Yu Yang, MD	886-4-22052121 ext 7390	d7857@www.cmuh.org.tw

Locations

Taiwan
National Taiwan University hospital	Recruiting
Taipei, Taiwan
Contact: Jeng Yi Shieh, MD 886-2-23123456 ext 7190 jyshieh@ha.mc.ntu.edu.tw

Sponsors and Collaborators

National Taiwan University Hospital

National Science Council, Taiwan

Investigators

Study Director:	Jeng Yi Shieh, MD	National Taiwan University Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00173745 History of Changes
Other Study ID Numbers:	9100012973; NSC93-2614-B-002-005
First Posted:	September 15, 2005
Last Update Posted:	December 21, 2005
Last Verified:	July 2002

Keywords provided by National Taiwan University Hospital:

cerebral palsy; drooling; botulinum toxin

Additional relevant MeSH terms:

Paralysis; Cerebral Palsy; Sialorrhea; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases	Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents