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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2002 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173745
First received: September 12, 2005
Last updated: December 20, 2005
Last verified: July 2002
History of Changes
  Purpose

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 Intervention
Cerebral Palsy
Drooling
 Drug: botulinum toxin A injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment of Drooling With Type A Botulinum Toxin A in Children With Cerebral Palsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • the effectiveness of botulinum toxin in treatment of drooling

Secondary Outcome Measures:
  • the most appropriated dosage of treatment
  • duration of effect
  • side effects

Estimated Enrollment: 20
Study Start Date: June 2003
Estimated Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   6 Years to 21 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00173745

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

No publications provided

ClinicalTrials.gov Identifier: NCT00173745     History of Changes
Other Study ID Numbers: 9100012973, NSC93-2614-B-002-005
Study First Received: September 12, 2005
Last Updated: December 20, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
cerebral palsy
drooling
botulinum toxin

Additional relevant MeSH terms:
Cerebral Palsy
Sialorrhea
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Neurologic Manifestations
 Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013