NCT00276315

Brief Summary

To compare the effectiveness and safety of Dysport® with the domestic Botulinum Toxin Type A (manufactured by Lanzhou Biologic Product Institute, P.R. China) for the treatment of hemifacial spasm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
332

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

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

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

First QC Date

January 12, 2006

Last Update Submit

April 27, 2020

Conditions

Hemifacial Spasm

Outcome Measures

Primary Outcomes (1)

  • Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels)

    At the end of week 4

Secondary Outcomes (3)

  • Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication)

    At the end of week 1 and 12

  • Improvement degree of spasm (Jankovic scale)

    At the end of week 1, 4 and 12

  • Assessment of efficacy by the subjects

    At the end of week 1, 4 and 12

Interventions

Botulinum toxin type ABIOLOGICAL
Also known as: AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient suffering from hemifacial spasm with at least 6 months duration (prior to visit 1)
  • Cohen scale ≥ to grade II

You may not qualify if:

  • Botulinum toxin type A treatment history within last 16 weeks prior to visit 1
  • Hemifacial spasm secondary to facial palsy
  • Previous alcohol or phenol injections or surgical therapy of the facial muscles
  • Requirement for botulinum toxin injection to site(s) of the body other than in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Neurology Department, Peking Union Medical College Hospital

Beijing, 100730, China

Location

Neurology Department, Guangdong Provincial People's Hospital

Guangdong, 510080, China

Location

Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, 310016, China

Location

Neurology Department, Shanghai Ruijin Hospital

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Hemifacial Spasm

Interventions

Botulinum Toxins, Type AabobotulinumtoxinA

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesSpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

December 1, 2005

Study Completion

January 1, 2007

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations

CN(4)