NCT00060957

Brief Summary

This study examines botulinum toxin (BOTOX, or BTX) for the treatment of muscle twitches and spasticity associated with cerebral palsy in children. Botulinum toxin is a naturally occurring bacterial toxin (botulinum toxin) that inactivates certain parts of muscles.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2003

Completed
Last Updated

September 26, 2016

Status Verified

May 1, 2011

Enrollment Period

4.9 years

First QC Date

May 16, 2003

Last Update Submit

September 23, 2016

Conditions

Cerebral PalsyMuscle Spasticity

Keywords

Cerebral PalsySpasticityBotulinum toxinBOTOX

Interventions

Botulinum toxin type ADRUG

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Spastic diplegic cerebral palsy
  • Community or independent ambulators
  • Expressive communication skills at age 3 or above
  • Stable social environment
  • Reasonable proximity to the medical center
  • Physical therapy at least once per week
  • No other serious health problems that would interfere with the study

You may not qualify if:

  • Other forms of cerebral palsy
  • Previous treatment with botulinum toxin
  • Musculoskeletal contractures greater than 15 degrees
  • Unstable social environment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital and Regional Medical Center

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ross M. Hays, M.D.

    Children's Hospital and Regional Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 16, 2003

First Posted

May 19, 2003

Study Start

July 1, 1997

Primary Completion

June 1, 2002

Last Updated

September 26, 2016

Record last verified: 2011-05

Locations

US(1)