Cerebral PalsyNCT00173745
Treatment of Drooling With Type A Botulinum Toxin in Children With Cerebral Palsy
A study testing botulinum toxin A injection in people with Cerebral Palsy and Drooling, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Cerebral Palsy, Drooling
- What is being tested?
- botulinum toxin A injection
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2003to Sep 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University hospital
Taipei
Jeng Yi Shieh, MD, 886-2-23123456 ext. 7190, jyshieh@ha.mc.ntu.edu.tw
About this study
Official title: Treatment of Drooling With Type A Botulinum Toxin A in Children With Cerebral Palsy
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.
Read the 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.
- Conditions
- Cerebral Palsy, Drooling
- Being tested
- botulinum toxin A injection
- Keywords
- cerebral palsy, drooling, botulinum toxin
- Medical subject headings
- Cerebral Palsy, Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin A injectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
the effectiveness of botulinum toxin in treatment of drooling
Secondary outcomes (3)
the most appropriated dosage of treatment
duration of effect
side effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Jeng Yi Shieh, MD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173745
- Sponsor's protocol ID
- 9100012973
- Other IDs
- NSC93-2614-B-002-005
- Status last verified
- Jul 2002
- First submitted
- 12 Sep 2005
- Last updated
- 21 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Drooling With Type A Botulinum Toxin A in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00173745
- Acronym / sponsor ID
- 9100012973
- Conditions
- Cerebral Palsy, Drooling
- Keywords
- cerebral palsy, drooling, botulinum toxin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jun 2003
- Study completion
- Sep 2005
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin A injection | Drug | – |
Primary outcome
the effectiveness of botulinum toxin in treatment of drooling
3 secondary outcomes
the most appropriated dosage of treatment
duration of effect
side effects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeng Yi Shieh, MD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing botulinum toxin A injection in people with Cerebral Palsy and Drooling, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jern Yi Shieh, MD (886-2-23123456 ext. 7190, JYSHIEH@HA.MC.NTU.EDU.TW), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effectiveness of botulinum toxin in treatment of drooling. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2005.