NCT00173745

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

December 21, 2005

Status Verified

July 1, 2002

First QC Date

September 12, 2005

Last Update Submit

December 20, 2005

Conditions

Cerebral PalsyDrooling

Keywords

cerebral palsydroolingbotulinum toxin

Outcome Measures

Primary Outcomes (1)

  • the effectiveness of botulinum toxin in treatment of drooling

Secondary Outcomes (3)

  • the most appropriated dosage of treatment

  • duration of effect

  • side effects

Interventions

botulinum toxin A injectionDRUG

Eligibility Criteria

Age6 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Cerebral PalsySialorrhea

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Jeng Yi Shieh, MD

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Jern Yi Shieh, MD

CONTACT

886-2-23123456JYSHIEH@HA.MC.NTU.EDU.TW

Pey Yu Yang, MD

CONTACT

886-4-22052121d7857@www.cmuh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

June 1, 2003

Study Completion

September 1, 2005

Last Updated

December 21, 2005

Record last verified: 2002-07

Locations

TW(1)