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

NCT ID: NCT00173745

Last Updated: 2005-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy Drooling

Keywords

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cerebral palsy drooling botulinum toxin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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botulinum toxin A injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Jeng Yi Shieh, MD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

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National Taiwan University hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jern Yi Shieh, MD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Pey Yu Yang, MD

Role: CONTACT

Phone: 886-4-22052121

Email: [email protected]

Facility Contacts

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Jeng Yi Shieh, MD

Role: primary

Other Identifiers

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NSC93-2614-B-002-005

Identifier Type: -

Identifier Source: secondary_id

9100012973

Identifier Type: -

Identifier Source: org_study_id