Treatment of Drooling With Type A Botulinum Toxin in Children With Cerebral Palsy
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| ClinicalTrials.gov Identifier: NCT00173745 |
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Recruitment Status : Unknown
Verified July 2002 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : September 15, 2005
Last Update Posted : December 21, 2005
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Sponsor:
National Taiwan University Hospital
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
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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 |
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 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 |
Resource links provided by the National Library of Medicine
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
Information from the National Library of Medicine
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| ClinicalTrials.gov Identifier: | NCT00173745 History of Changes |
| Other Study ID Numbers: |
9100012973 NSC93-2614-B-002-005 |
| First Posted: | September 15, 2005 Key Record Dates |
| Last Update Posted: | December 21, 2005 |
| Last Verified: | July 2002 |
Keywords provided by National Taiwan University Hospital:
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cerebral palsy drooling botulinum toxin |
Additional relevant MeSH terms:
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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 |